BOTOX Neurotoxin Muscle / Dentist USA

BOTOX Neurotoxin to Masseter Muscle Demo – Transcription

 

  1. SHATKIN: So that — because this is part of the consultation. So the patient comes to your office. She’s going to give you the history and then we’re going to —
  1. THARP: Tell me about your problems. Tell me what you’re going on, what’s going on.

MARLEY: Well, recently I’ve grinded my teeth at night.

MARLEY: Every morning I wake up and I just am so sore for the rest of the day.

  1. THARP: Point to where you’re sore.

MARLEY: Basically all in here.

  1. THARP: Right in there. Do you have any clicking or popping in your jaw joints?

MARLEY: Yeah, my jaw.

  1. SHATKIN: Jaw cracks. And when you wake up in the morning, it seems better. But by the end of the day, it’s problematic, or is it you wake up in the morning with a sore jaw?

MARLEY: I wake up with a sore jaw.

  1. THARP: Did you have any history of ever falling down and hitting your chin? Do you remember that at all?

MARLEY: I don’t believe so.

  1. THARP: That’s good. Do you notice any difference of when you’re under stress or tension and when you’re not under stress or tension?

MARLEY: Yeah, when I’m under stress I clench up a lot.

  1. THARP: So Dr. Dawson likes to see that when you’re doing a corroboration, it’s not always because you hate your mother. Anyhow, let me get the other girl on here and then we’ll see if we can do a quick exam to see how sore your muscles are.
  1. SHATKIN: So your history is pretty typical of what a TMJ patient has had. Have you had some therapies done up until now to help this?

MARLEY: No. But recently I have gone to a speech therapist because I have broken modules, and she’s noticed that it’s all combined with the tenseness with my jaw and throat.

  1. SHATKIN: Right.

MARLEY: And she’s worked on trying to just relieve some stress. She did the thing with the pinky up in the back molar.

  1. SHATKIN: And she felt that —
  1. THARP: Did she find out that your lateral pterygoid was hot?

MARLEY: Yes.

  1. SHATKIN: You had some pain there?

THARP: Good. Now when we do that exam, I want you to watch her eyes. Because even if the patient doesn’t say they’re having pain, when you get to the point where you’re touching a hot muscle, the eyes automatically cringe just a little bit.

  1. SHATKIN: And one last question before he exams you. Have you ever had a night guard or anything you wear to prevent the grinding at night?

MARLEY: Yeah, I’ve tried a small cap made by a dentist that goes on my bottom teeth, but it was just too uncomfortable. And then with other mouth guards, I’m too much of a light sleeper for it to — with me to fall asleep.

  1. SHATKIN: Would you find it that it would pop out of your mouth at the middle of the night and wake up on the pillow?

MARLEY: Yeah, it was too uncomfortable.

  1. SHATKIN: So you were pushing it out on your own. Ok, I’m going to step aside and let Dr. Therapa do your exam.
  1. THARP: Yeah, we’ll do the —
  1. SHATKIN: Can you zoom in there, Dave, maybe get a better view?
  1. THARP: First thing I’m going to do is just do a palpation exam of the joints. Everybody knows they’re right in front of the tragus. Go ahead and open, close. Open, close. Now do you feel any clicking at this point?

MARLEY: Yeah, in my left side.

  1. THARP: Without — normally I would do this with a doppler. Does anybody have a doppler in this room? Have you ever used one? They’re really quite fun and easy. It’s the same —
  1. SHATKIN: Let’s see if we can get it.
  1. THARP: Yeah, you might be able to hear it. Open. Not hearing it.
  1. SHATKIN: Those are high heels in the back of the room
  1. SHATKIN: Not really significant.
  1. THARP: And good, she’s brought me a tongue compressor. This is something that I always teach every young dentist that I’ve gotten. Centric relation is, you would think, very hard for a patient to get into, and it isn’t. A patient can — you can put a patient themselves into centric relation. You take a flat surface like a tongue compressor, or what I like to use is my mouth mirror. Put it right between their center of their teeth, close. Ok now slide your lower jaw forward and back. Forward, back. Now do you feel any clicking, by the way, when we do that? It should be the same type of clicking when you do it open and close.

MARLEY: Uh-huh.

  1. THARP: Now when you go all the way to the back, she’s going to be in centric relation, or if she has a damaged joint because of the clicking. She’ll be what we call adapted centric posture. Now, lighten up that state all the way in that back position, and she’s already in centric right there. Now, what you do to teach a patient that there might be something wrong with their bite, go ahead and stay in that back position, all the way in the back. Not forward, go to the back again. You can watch them smile at me and do that. Just smile.

 

  1. SHATKIN: Don’t choke
  1. THARP: There you go. So she’s in centric right there, or darn close to it. Now, lighten up just as light as can be. I’m going to slide the tongue compressor out. And I want you to close straight up feather-like and tell me if you hit any of your teeth first, ok? Close feather-like straight up. Did you hit any one tooth first?

MARLEY: Uh-huh.

  1. THARP: Point to it. Right there, and it’s usually in the first bi-area. That’s the most common. Most people think it’s the second molars, but that’s the most common interference for when you’re doing that kind of corroboration. So she just learned there’s something wrong with her bite that might be making her want to grind her teeth more. Let me do one more demonstration. We’re going to try that same thing. Tilt your head way there. Let me cradle your head. Thumbs on a chin. Second and third fingers way in the back at the corner of the mandible. And I’m just going to give you open and close with me, feather-like. Let me just see if we can get that at the same spot. And I’m pushing mainly up with the back. And now it’s started to come together until you barely touch. Did you hit the same spot?

THARP: That’s the confirmation that she has an interference that maybe want her to grind more. So now, take your little finger. Go right up past the second molars and watch her eyes. Shift your jaw to the left a little bit. A little — that’s it, good. See, you see them blink? Does that hurt?

  1. THARP: Now do the same thing on the other side. Shift your jaw to the left, other left. Your right, rather. Your right — there we go, good. And the right side now will hurt just a little bit, but not as bad, right?

MARLEY: Yeah.

  1. THARP: So she’s got — she’s got a hot lateral pterygoid. And if we had a doppler, we could confirm that she has an opening click that is reciprocal — that the disc actually is clicking. Once you open the clicking back onto the head of the condyle, clicking back off once she comes back to adapted centric posture. It’s no longer centric relation once you have a damaged joint. What we want to do — you can also palpate the temporalis, the lateral pterygoid, the internal pterygoid — I’m sorry, not [inaudible 6:52] pterygoid, the masseters. But usually you don’t get painful muscles except the lateral pterygoid. Anything there?
  1. THARP: A little bit right there? So she’s even sore in her masseters. That means she’s really gnashing. It’s [difficult 7:09].
  1. THARP: So I’m looking forward to helping you. You may not get it until a week from now, but you’ll notice a big difference in how your pain level is. Do you get headaches? THARP: Point to where you get the headaches at. Right here?

MARLEY: Yeah, more in the forehead.

  1. THARP: Right there. Yeah, it almost always comes right at the —
  1. SHATKIN: The tension.
  1. THARP: Interior part of the temporalis. Sometimes you get it here, sometimes you get it in the back.

MARLEY: Yeah. It goes randomly.

  1. SHATKIN: That was good. Alright, so why don’t you take her through the marketing process or do you want me to do the marketing process?
  1. THARP: You do the marketing process.
  1. SHATKIN: I’m going to give you this microphone back and grab some — there you go.
  1. THARP: I’ll just take it.
  1. SHATKIN: And then I’m going to get — this is how I do it. I let the dentist do the diagnostic part of it, and then I’ll come in and if they’re referred from my dental practice here or somewhere else. Actually, the reason I had a patient that came in from Maryland to have the injections done, actually a dentist sent her to me because he knew that I did this. And she flew down in the morning and flew back in the afternoon. So we’re going to —

NURSE ACKERMAN: Are you going to mark her first?

  1. SHATKIN: Yeah, I’ll mark her. I’m going to let Kathy dilute this for us so she can get it ready. And we’re going to show you the dilution later. So basically, it’s really pretty simple. Just like we did on our styrofoam dummies. I’m going to have her bite down and I’m feeling the anterior border of the masseter [8:38] right here. It’s obvious. It’s hard to miss. Relax. When they’re relaxed, you can still feel it on here. But many times, you can’t. So bite that down again. So I’m just going to mark the anterior border right there with my marking pen. Now, relax. Now I’m going to mark the back. Sorry, go ahead and bite again. Right here. The only other anatomic area — you can relax now — is the inferior border of the mandible near the angle. The mandible is right here. So I want to be up in this area. I don’t want to be up too high. The protygland is back in here. So part of the product is overlined in the masseter muscle. So we’re going to pretend that we don’t want the product injected, although sometimes we’ll put Botox in the product. But it doesn’t make any sense to do that. So we’ll try to stay a little bit more if we go to divide this in half. We’re going to go a little bit more on the anterior side of it. But either way, you’re going to [inaudible 9:32] with the bulk of the muscle. A lot of instructors suggest you want to avoid piercing the protygland. I don’t think it’s a big problem unless you hit one of the ducts or some major duct there where you could get salivary cyst or some drainage. You wouldn’t want to do that. So that’s why for our purposes, we’re going to stay a little bit more towards the anterior surface of it.

So Ms. [9:55], go ahead and clench again. I can see your muscle balls. Her bulkiest part of the muscle is right here. I’m going to put one dot there, and then we’ll just go a little bit below that, perhaps. And I’ve got my two spots there that I’m going to inject. So now I’m going to do the same thing on the other side so the people on this side can see. So go ahead and bite down. I’m feeling the border there. Remember what I said: the facial artery is coming about a centimeter right across here, so we want to stay away from that. Bite down again. I’m going to mark the posterior aspect right there. And then bite down real hard. So she’s got — this side is a little bit different. The bulk is more right here. And then I’m going to do it just another section there. So they don’t have to be exactly symmetrical because as Dr. Tharp pointed out, she’s got more left lateral pterygoid problem than she has on the right side. So that could be why the masseter is a little bit different shape there. But these are my two marks. Now if you want to be safe, when you’re drawing this like we did on our facial skull there. Draw a line there so you’re not actually hitting the dots where I marked in there, because that would be a big mistake. You don’t want to do that.

So what Kathy did was she — did you reconstitute it yet?

NURSE ACKERMAN: Not yet. I just wanted to show up because not everybody — well we’re going to have people reconstituting, but not everybody will get a [freeze-dried 11:07].

  1. SHATKIN: Let’s go over this. Thank you, Kathy. So she drew out of the bacteriostatic saline, which is buffered saline, which would give you a little bit of up to one week or ten days of use of the Botox. She drew up 1cc and a little bit more. I recommend using 1cc syringes because if you’re using three and you’re off slightly, it will just change the concentration. So if you use one, it’s a little bit more exact. So a little bit more than 1cc, you’re going to push it up until you get exactly to the one. You can’t see from where you are, but you will when you’re up close. And then she popped off the outer cap. It’s sterile inside, so you don’t have to cleanse it with alcohol. It’s still sterile. And then you’re just going to take this and push it right in. It’s freeze-dried, which is interesting. The bottom — the very first Botox I got, I thought there was nothing in there. I knew you had to reconstitute, but I’m looking at it and saying, I don’t think there’s anything in there. But then I called up the company, and they said, yeah, they said there’s something in there. It’s basically freeze-dries in the bottom of the bottle, and that’s the difference between this and Xeomin. Xeomin coats the total lining of the bottle and you have to agitate it a little bit differently. But with this Botox, you just put the needle through here. It’ll draw it in. You see it draw right in because it’s in the vacuum. You don’t want to force it in. You don’t want to agitate it. You don’t want to shake it. You just want to put it in like that, and then what I usually do is I just do this on the table, or you can spin it like this. Sometimes they recommend just rotating it like this, but in a gentle, comfortable way. We’re going to have some bottles for you to practice on later. So then what we do is we take that out, and I like to take the cap off. Problem is if you stick a needle through this now, as you’re going to clean it with alcohol, it’s going to dull the needle. And I got a picture of that on the next talk, which we’re going to do after lunch.

So we’re going to pop this off. You can use actually a can opener, but we use the scissors because we got them in the office. You just pop them off, and you leave the rubber cap there. If it comes loose, you can always take it off later. So there, I took the cap off. Here’s our rubber cap. So the [substance 13:09] that goes back on. There’s our solution. Now there’s different ways to draw it up, and every time you stick that needle into something that’s glass, it’s going to dull the tip. I usually do no more than five injections through the skin with one needle. Now because she’s got a — because the masseter’s a deeper muscle, we’re going to use our 1cc syringe. And we’re going to use the half-inch needle like I mentioned before. And I just happened to have a 30 gauge. [inaudible 13:35] I’m going to use a 30 gauge needle, a little more comfortable, but it’s half-inch. This is like, I think, 3/8ths of an inch, so it goes a little bit deeper. So we got the 1cc syringe and what we’re going to do is we’re going to draw up the Botox equivalent to that amount. So we put 1cc in there. So that’s every 10th of a cc is 10 units. Because you have 10/10ths is a full. So every 10th is 1cc, so I’m going to make sure that needle is [squished 14:06] down properly. It should fit the syringe easily, and we’re going to put it in there. And since I want five units in two spots, that’s 10 units total, I’m going to drop one-tenth of a cc. Pretty easy, right? I try not to let the needle touch down at the bottom too much. If it does touch a little bit, it’s ok, but very lightly. And then I’m going to draw it up. Now what did I do wrong? I didn’t push the air out first. Put it back in there. Remember I told you, we got to push out the air like we showed you earlier, and then we’re going to put that in there and draw it up to 1/10th. 1/10th cc, there we go. No, I’m going to do it — well, we’ll do it twice. I’ll do it two times. We’ll draw it two times so we do both sides. Sometimes you get a little bubble there. So draw it up until the line we want to put in, 2/10ths. So we do half on each side. So I cleanse the skin with it. I’ve already got it marked, I cleanse the skin, a little tissue.

MAN 1: Each tenth you used ten units.

  1. SHATKIN: Right. The way to do five and five, on one side, five, and five on the other side.

MAN 2: So what’s the saline for? I lost you.

  1. SHATKIN: We reconstituted it because it comes freeze-dried in the bottle. So we mix it in there to reconstitute it. That’s all the saline we put in there. No more saline.

MAN 2: How much saline are you putting into one bottle?

NURSE ACKERMAN: 1/16th.

  1. SHATKIN: We put 1mL, 1cc. That takes 100 units for 1cc.

MAN 2: So one to one. We’re diluting it in half.

  1. SHATKIN: 1cc. Well no, not half. It’s dry to start with. There’s nothing in there, no liquid in there.

MAN 2: Oh, you’re just making it.

  1. SHATKIN: Yeah, we’re just making it. That’s the recap. We’re going to do some more of that later, but we got the demonstration gals here, so we want to do it now. So I just cleanse the skin and sometimes patients walk out of the office with the tissue underneath their shirt here because — yeah?

AUDIENCE: Can you turn her towards this way?

  1. SHATKIN: Yeah, let me turn her this way. Now everybody can see. Then I’ll stand on this side, maybe that will be better. Turn your head this way. So here’s my spots, clench down. I want 10 on each side, isn’t that what we decided, 10 on each side? So I’m going to put half of the 1/10th on one spot, all the way in. And half of the 1/10th in the other spot, keep clenching. And then that side’s done. I’ll do a little massage there just so it won’t drip. Now the other side, for the purpose of the people that are looking on the other side, clean it with some alcohol just to cleanse the skin. That’s all I have to do to clean it. Go ahead and clench down. The biggest, bulkiest spot of that —
  1. THARP: And you’re going all the way in with that needle.
  1. SHATKIN: The needle’s all the way in. And then that’s it. It’s a half-inch deep, but remember, your skin’s thickness affects it a little bit. And then that’s it. That wasn’t too bad, was it?

Non-biodegradable Dermal Fillers

Several non-biodegradable fillers are available (Table 1.2). As well as being expensive, frequent injections can be quite tiresome for both the patient and the physician, and so the application of a non-biodegradable or permanent filler holds a certain attraction. Conversely, there are certain disadvantages that should be taken into account. First, patients of all ages can be treated in aesthetic medicine. It may therefore be quite uncertain how a permanent depot will appear after 3 or even 4 decades, by which time age and solar- induced elastosis has reduced the dermal and epidermal layers. Second, there is always a possibility of adverse reactions to fillers. The most common subacute or late reaction to permanent fillers is the development of a granuloma. Treatment of an adverse reaction to a filler material is much more difficult when the filler is non-biodegradable because it will provide a permanent stimulus for the surrounding tissue.

Silicone Dermal Filler

Injectable silicone filler is one of the oldest injectable filler materials used. Medical-grade silicon is a clear, oily, colorless liquid composed of long chains of polymerized dimethylsiloxane. There are several methods of injection for this product. One of the recommended techniques is the microdroplet technique (Orentreich 2000; Webster et al. 1986). Fluid silicone is injected into the dermis as 0.01 ml microdroplets. Each mircodroplet is separated by 1 mm. Undercorrection is recommended as the main side effect is a foreign body ( fibrotic) reaction. In fact, as a result of severe adverse reactions, the FDA declared the use of injectable silicone illegal in 1991. Nevertheless, silicone oil is still widely used in other countries.

Polyacrylamide Aquamid

Polyacrylamide (trade name Aquamid) is composed of 97.5 % water and 2.5% cross-linked poly- acrylamide. It is recommended for folds, skin sculpturing, and facial atrophy. It is not effective for new wrinkles. Aquamid should be injected deeply using the subcutaneous tunneling tech- nique (Breiting et al. 2004; De Cassia Novaes and Berg 2003).

Combination of Non-biodegradable and Biodegradable Fillers

Some fillers are a combination of non-biodegradable (permanent) and biodegradable (temporary) materials. The purpose of the biodegradable material is to act as a carrier and to ensure an immediate effect until the fibrotic foreign body reaction induced by the non-biodegradable filler leads to visible effects.

Polymethylmethacrylate PMMA and Collagen – Bellafill / ArteFill

The combination of polymethylmethacrylate (PMMA) and collagen (Artefill / Bellafill) was introduced at the end of the 1980s and is the oldest available combination preparation. PMMA beads are suspended in a solution of 3.5% bovine collagen (as a carrier) and 0.3 % lidocaine (for pain relief). While the collagen resorbs over a period of 2–3 months, the PMMA spheres become en- capsulated by fibrotic material. Bellafill PMMA has been used for a variety of aesthetic indications.

Artecoll / Artefill / Bellafill PMMA should be injected into the lower third of the dermis with a 26- to 27-gauge needle using the tunneling technique. The material should not be injected too supercially; the needle should never be visible through the skin. Careful massage with a fingertip after application helps to distribute the material more evenly. Overcorrection is not advisable; however, a second implantation may be necessary after 3 months (Lemperle et al. 2003). Although the preparation contains collagen, in Europe a skin test is not mandatory (personal communication Ro l Medical International).

Hydroxyethylmethacrylate and Hyaluronic Acid – DermaLive

Hydroxyethylmethacrylate (HEMA) and ethylmethacrylate microspheres suspended in hyaluronic acid have been available in Europe as DermaLive since the end of the 1990s. This product consists of 40% bacterial hyaluronic acid and 60% acrylic hydrogel particles (diameter of 45–65 μm). A similar formulation with larger- sized particles (about 85–110 μm) and a somewhat higher hyaluronic acid content is marketed as DermaDeep and is intended to be injected deeper.

DermaLive should only be injected with a 27.5-gauge needle into the deeper layers of the dermis, at the junction between the dermis and the hypodermis, with the tunneling technique, while DermaDeep is supposed to be injected with a slightly bigger needle (26.5-gauge) deeper into the subperiosteal layer or the hypodermis. Overcorrection must be avoided. In addition, it is recommended that a period of at least 3 months should be le between two injection sessions (Bergeret-Galley et al. 2001).

Buy CAHA Radiesse Calcium Hydroxylapatite

Calcium hydroxylapatite (CHP / CAHA) is another comparatively new product that is made from synthetically formed calcium phosphate pearls, a procedure that is classified as bioceramics and involves the ionic bonding of calcium and phosphate ions. When injected they form a foundation within a matrix that allows the local cellular infiltration of fibroblasts. e complex is available as a gel to allow easier application.

Again, as for the majority of injectable llers, there are 40 clinical trials that show equivalence or even superiority to standard products (Comite et al. 2004; Sklar and White 2004; Tzikas 2004). Based on information from the manufacturer, the e ects of this product should last longer than for other biodegradable products.

In contrast to the other fillers, CHP is visible on x-rays; patients should be informed of this so that they can tell their doctors should they re- quire an x-ray of the face.

Hyaluronic Acid Injections dermal filler – Belotero, Juvederm Voluma, Restylane. USA, UK, Canada, Australia

Hyaluronic Acid Dermal Fillers

After the bovine collagens, the emergence of different hyaluronic acid preparations has revolutionized the injectable filler market because they require no prior skin test. Hyaluronic acid, which belongs to the family of glycosaminoglycans, consists of repeated disaccharide units. e hydrophilic properties of hyaluronic acid attract water into the extracellular matrix and therefore increase the skin turgor. Hyaluronic acid is gradually degraded. In order to increase the durability of the various hyaluronic acid preparations, stabilization is usually obtained by cross linking with several substances, such as 1.4-butanediol diglycidyl ether, which is found in Restylane.

Hyaluronic acids can be derived from avian or bacterial sources; each product has its own, specific characteristics. Several preparations adapted for different injection depths are available for most products, which di er based on the concentration of hyaluronic acid and the degree of cross-linking, and thus the rate of degradation.

Hyaluronic Acid of Avian Origin

Cross-linked hyaluronic acid of avian origin became the first non collagen filler to be widely used. e Hylaform product family is based on hyaluronic acid derived from processed rooster combs. Several products with different viscosities allow the treatment of different dermal levels. e Hylaform product family, with an average content of hyaluronic acid of 5.5 mg/ml, is easy to inject due to its superior rheological proper- ties and is less palpable than some products of bacterial origin (Manna et al. 1999).

In 2003, data from a clinical trial comparing Hylaform with Zyplast for the treatment of nasolabial folds was presented to the FDA. A total of 480 patients were included in this study which, to our knowledge, has not yet been published. Based on the data that are available from the FDA, no difference between the products could be established. A er 12 weeks the mean (±standard deviation) wrinkle severity score, which ranged from 0 to 5, was 3.3±1.11 for Hylaform and 2.2±1.12 for Zyplast (http://www.fda.gov/).

Hyaluronic Acid of Bacterial Origin

Typical examples for bacterial hyaluronic acid products are the Restylane and Juvederm / HydraFill families. e hyaluronic acid used for these products has a lower molecular weight, but is used at a higher concentration than the avian products: 20 mg/ml for Restylane and 24 mg/ml for Juvederm / HydraFill.

e rheology of these products is less than that of avian hyaluronic acid, and therefore in- creased pressure has to be applied while inject- ing the material into the dermis. Furthermore, a er injection the product is much more palpable. For example, when treating nasolabial folds the product remains palpable as a threadlike structure for days or even months. e material dissolves more gradually, however, and so over- correction is not necessary.

In contrast to other hyaluronic-acid-based products, clinical trials focusing on safety and durability exist for Hyalform and Restylane. A randomized controlled clinical trial was conducted to compare the e cacy and safety of Restylane and Zyplast. A total of 137 patients were included in the intention-to-treat analysis. A er 6 months the authors concluded that Restylane was superior to Zyplast (based on the assessment of the Winkle Severity Rating Scale). e superi- ority of Restylane (i. e., where the investigator felt that Restylane was more effective) was observed in 56.9 % of their patients, compared to 9.5 % pa- tients in whom the investigator felt that Zyplast was superior (p<0.0001). ose patients in whom there was no difference between these products (33.6 %) were not included in the simple univariate statistics (Narins et al. 2003). Although the authors concluded that Restylane was superior to Zyplast, it was later determined by the FDA that these data were not su cient to claim the superiority of Restylane compared to Zyplast at the de ned study endpoint of 6 months. No such data exist at the moment for any of the other bac- terial hyaluronic acid products. However, clini- cal trials for Juvederm/HydraFill in the United States are underway and are expected to be com- pleted soon.

Combination of Hyaluronic Acid and Dextranes

Combination of hyaluronic acid, hydrox- proylmethylcelluose and dextranes, marketed as Matridex, is thought to be more durable than other products. However, there is as yet no good clinical data on its e cacy and safety.

Polylactic Acid

Polylactid acid (PLA) is a synthetic biodegrad- able material. It is basically the same substance as that used in suture material. When injected into the deep dermis it gradually stimulates collagen formation. is takes some time and the manu- facturer recommends three initial treatment ses- sions, each approximately 6–8 weeks apart. A er the three initial treatments the result are sup- posed to last for up to 2 years. erefore, PLA cannot be compared with a standard ller like hyaluronic acid where the e ects can be seen im- mediately and where the results gradually abate a er each injection.

is product has to be diluted with sterile wa- ter at least 2 h before injection. Although initially the recommended dilution for PLA was 3 ml, the current recommendation is to dilute it in a vol- ume of 5 ml. Some of our colleagues add 1 ml of a local anesthetic to decrease the pain associated with the injection. Only retrograde injection is recommended. Even when administered using the correct injection technique and the higher dilution, in some cases the needle will block dur- ing the injection, at which point the needle has to be changed.

us far, studies on the e cacy and safety of PLA are based mainly on the treatment of HIV patients with drug-induced lipoatrophy (Moyle et al. 2004; Perry 2004; Valantin et al. 2003). Only case reports and case series exist for the use of PLA for aesthetic indications (Rzany et al. 2004; Woerle et al. 2004). According to the manufacturer, a clinical trial covering aesthetic indications is under way in the United States.

Overview of Injectable Fillers – Collagen

Biodegradable Fillers

Biodegradable llers are de ned as having a limited life span usually ranging from a couple to several months, or even to a couple of years. ey usually consist of puri ed dermal compo- nents from human, animal, or bacterial sources and can be divided into the following categories: xenogra s (donor and recipient are from di er- ent species), autogra s (donor and recipient are from the same individual), homogra s (donor and recipient are from the same species), and synthetic materials.

Collagen
Collagens from various sources and with speci c characteristics exist. erefore, it is important to discuss the di erent products separately.

Collagen of Bovine Origin

Prior to the introduction of the hyaluronic acids, collagen was the most widely used ller and was considered the gold standard with which other dermal llers were compared. e classical bo- vine enzyme-digested collagen (95 % type I, 5 % type III) is available in several preparations, which can be distinguished by the collagen con- tent and the addition of glutaraldehyde for sta- bilization (Homicz and Watson 2004). Glutar- aldehyde crosslinks lysine residues within the collagen structure, thereby increasing the stabil- ity of the product and its ability to resist in vivo enzymatic degradation.

Depending on the collagen content and the degree of crosslinking, di erent products should be used for di erent levels of the dermis. For ex-

ample, Zyderm 1 and Zyderm 2, which are llers with noncrosslinked collagen, should be injected super cially into the papillary level of the der- mis. Zyplast, a crosslinked form, should be in- jected more deeply into the reticular layer. All of these products are easy to inject. Furthermore, overcorrection is recommended for Zyderm 1 and Zyderm 2, as these collagen preparations will loose volume over time.

Zyderm Collagen was cleared for market- ing in 1981 by the Food and Drug Administra- tion (FDA) a er reviewing clinical data based on a large case series of 9,427 tested and 5,109 treated patients (Cooperman et al. 1985; Matti and Nicolle 1990). In addition to this case series, which focused mainly on safety issues, a recent clinical trial showed that it was e ective for at least several months (Cooperman et al. 1985; Matti and Nicolle 1990)

As collagen may elicit hypersensitivity reac- tions, pretesting is so far mandatory. Pretesting consists of an intradermal injection of Zyderm 1 collagen into the volar aspect of the forearm. A minimum of one skin test should be admin- istered and evaluated a er 28 days.

Collagen of Porcine Origin

A few porcine collagen-based llers have been described in the literature (Saray 2003). How- ever, they have not been widely used. A novel porcine collagen ller, Evolence, was introduced into the European market in 2004. In contrast to other collagens, this product is crosslinked by mimicking the process of collagen glycation using d-ribose as the crosslinking agent. A ran- domized clinical trial is currently under way with the objective of presenting the superior ef- cacy of Evolence to bacterial hyaluronic acid for the treatment of nasolabial folds. Data on the e cacy of the implant have not yet been pub- lished. e company that produces this collagen ller states a product durability of at least 1 year. In the recent Conformité Européenne (CE) cer- ti cation of Evolence, pretesting was not consid- ered a prerequisite.

Collagen of Human Origin

Collagen of human origin can be of allogenous or autologous nature.

Collagen of Allogenous Nature (from Cadaver)

In addition to bovine or porcine sources, colla- gen can be derived from human cadavers. Data is available for two products: Dermalogon and Cymetra. Both products derive from pooled hu- man cadaverous tissue from accredited tissue banks. Overcorrection is recommended by the manufacturer. Here again the available data on the e cacy and safety of the product are limited. Cymetra was tested against Zyplast in a random- ized controlled trial. A total of 47 patients were treated: 20 received Cymetra and 27 received Zyplast. Various photometric outcome measures

Collagen of Allogenous Nature (from Culture)

Later-generation noncadaverous collagen prod- ucts are CosmoDerm and CosmoPlast. ey are made from natural human collagen grown un- der controlled laboratory conditions. ere is no need for a pretreatment skin test for these ster- ile devices, which are composed of highly puri- ed human-based collagen that is dispersed in phosphate-bu ered physiological saline contain- ing 0.3% lidocaine. CosmoDerm is a noncross- linked formulation that is used in the treatment of super cial lines, whereas CosmoPlast is cross- linked and is used primarily in the treatment of more pronounced wrinkles. ese products are not available in countries outside of the United States; regulations surrounding products of hu- man origin vary on a country-by-country basis (Bauman 2004). No clinical trials are available because the FDA concluded that since Cos- moDerm and CosmoPlast represent a material source change to Zyderm and Zyplast (from bo- vine- to human-based collagen), they did not re- quire new clinical e cacy studies to be carried out.

Collagen of Autologous Nature

e commercial preparation Autologon consists of dermal extracellular matrix, primarily col- lagen (types I, III, and VI), that has been har- vested from the patient‘s own skin. It requires the excision of the patient‘s skin and is therefore mostly suitable for those undergoing surgical procedures. Here again, overcorrection is rec- ommended by the manufacturer. e available data on the e cacy and safety of the product are limited (Sclafani et al. 2000).