Utilisation of locally delivered doxycycline in non-surgical treatment of chronic periodontitis. A comparative multi-centre trial of 2 treatment approaches.

AIM: In the present 6-month multicentre trial, the outcome of 2 different approaches to non-surgical treatment of chronic periodontitis, both involving the use of a locally delivered controlled-release doxycycline, was evaluated. MATERIAL AND METHODS: 105 adult patients with moderately advanced chronic periodontitis from 3 centres participated in the trial. Each patient had to present with at least 8 periodontal sites in 2 jaw quadrants with a probing pocket depth (PPD) of > or =5 mm and bleeding following pocket probing (BoP), out of which at least 2 sites had to be > or =7 mm and a further 2 sites > or =6 mm. Following a baseline examination, including assessments of plaque, PPD, clinical attachment level (CAL) and BoP, careful instruction in oral hygiene was given. The patients were then randomly assigned to one of two treatment groups: scaling/root planing (SRP) with local analgesia or debridement (supra- and subgingival ultrasonic instrumentation without analgesia). The "SRP" group received a single episode of full-mouth supra-/subgingival scaling and root planing under local analgesia. In addition, at a 3-month recall visit, a full-mouth supra-/subgingival debridement using ultrasonic instrumentation was provided. This was followed by subgingival application of an 8.5% w/w doxycycline polymer at sites with a remaining PPD of > or =5 mm. The patients of the "debridement" group were initially subjected to a 45-minute full-mouth debridement with the use of an ultrasonic instrument and without administration of local analgesia, and followed by application of doxycycline in sites with a PPD of > or =5 mm. At month 3, sites with a remaining PPD of > or =5 mm were subjected to scaling and root planing. Clinical re-examinations were performed at 3 and 6 months. RESULTS: At 3 months, the proportion of sites showing PPD of < or =4 mm was significantly higher in the "debridement" group than in the "SRP" group (58% versus 50%; p<0.05). The CAL gain at 3 months amounted to 0.8 mm in the "debridement" group and 0.5 mm in the "SRP" group (p=0.064). The proportion of sites demonstrating a clinically significant CAL gain (> or =2 mm) was higher in the "debridement" group than in the "SRP" group (38% versus 30%; p<0.05). At the 6-month examination, no statistically significant differences in PPD or CAL were found between the two treatment groups. BoP was significantly lower for the "debridement" group than for the "SRP" group (p<0.001) both at 3- and 6 months. The mean total treatment time (baseline and 3-month) for the "SRP" patients was 3:11 h, compared to 2:00 h for the patients in the "debridement" group (p<0.001). CONCLUSION: The results indicate that simplified subgingival instrumentation combined with local application of doxycycline in deep periodontal sites can be considered as a justified approach for non-surgical treatment of chronic periodontitis.

An economic evaluation of a chlorhexidine chip for treating chronic periodontitis: the CHIP (chlorhexidine in periodontitis) study.

BACKGROUND: The authors previously suggested that an adjunctive, controlled-release chlorhexidine, or CHX, chip may reduce periodontal surgical needs at little additional cost. This article presents an economic analysis of the CHX chip in general dental practice. METHODS: In a one-year prospective clinical trial, 484 chronic periodontitis patients in 52 general practices across the United States were treated with either scaling and root planing, or SRP, plus any therapy prescribed by treating, unblinded dentists; or SRP plus other therapy as above but including the CHX chip. Economic data were collected from bills, case report forms and 12-month treatment recommendations from blinded periodontist evaluators. RESULTS: Total dental charges were higher for SRP + CHX chip patients vs. SRP patients when CHX chip costs were included (P = .027) but lower when CHX chip costs were excluded (P = .012). About one-half of the CHX chip acquisition cost was offset by savings in other charges. SRP + CHX chip patients were about 50 percent less likely to undergo surgical procedures than were SRP patients (P = .021). At the end of the trial, periodontist evaluators recommended similar additional procedures for both groups: SRP, about 46 percent; maintenance, about 37 percent; surgery, 56 percent for SRP alone and 63 percent for SRP + CHX chip. CONCLUSIONS: Adjunctive CHX chip use for general-practice patients with periodontitis increased costs but reduced surgeries over one year. At study's end, periodontists recommended similar additional surgical treatment for both groups. CLINICAL IMPLICATIONS: In general practice, routine use of the CHX chip suggests that costs will be partially offset by reduced surgery over at least one year.

The effect of locally delivered controlled-release doxycycline or scaling and root planing on periodontal maintenance patients over 9 months.

BACKGROUND: This research report evaluates clinical changes resulting from local delivery of doxycycline hyclate (DH) or traditional scaling and root planing (SRP) in a group of patients undergoing supportive periodontal therapy (SPT). METHODS: In all, 141 patients received either DH (67) or SRP (74) treatment in sites > or =5 mm on one-half of their dentition at baseline and month 4. RESULTS: Clinical results were determined at month 9. Baseline mean probing depth recordings were similar between the two groups (DH = 5.9 mm; SRP = 5.9 mm). Mean month 9 results showed similar clinical results for attachment level gain (DH 0.7 mm; SRP 0.8 mm) and probing depth reduction (DH 1.3 mm; SRP 1.1 mm). Percentage of sites showing > or =2 mm attachment level gain at month 9 was 24.7% in the DH group and 21.2% in the SRP group. Thirty-nine percent (39%) of DH sites and 38% of SRP sites showed > or =2 mm probing depth reduction. When treated sides of the dentition were compared to untreated sides, DH showed a difference in disease activity (> or =2 mm attachment loss) from 19.3% (untreated) to 7.2% (treated); and SRP from 14.3% (untreated) to 8.1% (treated). CONCLUSIONS: Results show that both DH without concomitant mechanical instrumentation and SRP were equally effective as SPT in this patient group over the 9-month study period.

The cost-effectiveness of a new chlorhexidine delivery system in the treatment of adult periodontitis.

BACKGROUND: Periodontal treatment is costly. The authors assessed the potential economic impact of a new periodontal chemotherapeutic, testing the hypothesis that its adjunctive use would result in reduced periodontal surgical needs. METHODS: An economic model estimated treatment needs following two clinical trials of the adjunctive use of a chlorhexidine, or CHX, -containing chip compared with scaling and root planing, or SRP, alone. Needs were based on periodontal status at nine months and a probabilistic algorithm; costs were assigned on the basis of a national dental survey and an average wholesale price of the CHX chip. RESULTS: The base case model projected significantly more maintenance procedures and significantly fewer periodontal surgical procedures for patients treated with SRP and the CHX chip compared with patients who were treated with SRP alone (54.4 percent vs. 46.4 percent, P = .014; 29.2 percent vs. 35.5 percent, P = .015, respectively). Average total costs of care for patients treated with SRP and CHX chip were $737 +/- $244 compared with $734 +/- $239 for patients treated with SRP alone. Sensitivity analyses to account for variations in practice patterns did not appreciably alter the results. When data were analyzed after only three or six months of treatment, the significant differences in treatment needs disappeared. CONCLUSIONS: The CHX chip is a new, apparently cost-effective treatment option for non-surgical periodontal therapy. Adjunctive use of the CHX chip could reduce periodontal surgical needs significantly at little or no additional cost. CLINICAL IMPLICATIONS: Results suggest that incorporating the CHX chip into routine practice requires a new algorithm for management of periodontal disease. To obtain full clinical benefit, treatment needs to be continued for nine months.

Two multi-center studies evaluating locally delivered doxycycline hyclate, placebo control, oral hygiene, and scaling and root planing in the treatment of periodontitis.

BACKGROUND: The clinical efficacy and safety of doxycycline hyclate (8.5% w/w) delivered subgingivally in a biodegradable polymer (DH) was compared to placebo control (VC), oral hygiene (OH), and scaling and root planing (SRP) in 2 multi-center studies. METHODS: Each study entered 411 patients who demonstrated moderate to severe periodontitis. Patients had 2 or more quadrants each with a minimum of 4 qualifying pockets > or =5 mm that bled on probing. At least 2 of the pockets were > or =7 mm. Treatment with DH, VC, OH, or SRP was provided at baseline and again at month 4. Clinical parameters were recorded monthly. RESULTS: DH and SRP resulted in nearly identical clinical changes over time in both studies. Mean 9 month clinical attachment level gain (ALG) was 0.8 mm for the DH group and 0.7 mm for the SRP group in Study 1, and 0.8 mm (DH) and 0.9 mm (SRP) in Study 2. Mean probing depth (PD) reduction was 1.1 mm for the DH group and 0.9 mm for the SRP group in Study 1 and 1.3 mm for both groups in Study 2. Frequency distributions showed an ALG > or =2 mm in 29% of DH sites versus 27% of SRP sites in Study 1 and 31% of DH sites versus 34% of SRP sites in Study 2. PD reductions > or =2 mm were seen in 32% of DH sites versus 31% of SRP sites in Study 1 and 41% of DH sites versus 43% of SRP sites in Study 2. Comparisons between DH, VC, and OH treatment groups showed DH treatment to be statistically superior to VC and OH. Safety data demonstrated a benign safety profile with use of the DH product. CONCLUSIONS: Results of this trial demonstrate that treatment of periodontitis with subgingivally delivered doxycycline in a biodegradable polymer is equally effective as scaling and root planing and superior in effect to placebo control and oral hygiene in reducing the clinical signs of adult periodontitis over a 9-month period. This represents positive changes resulting from the use of subgingivally applied doxycycline as scaling and root planing was not limited regarding time of the procedure or use of local anesthesia.

Assessing the effectiveness of locally delivered chlorhexidine in the treatment of periodontitis.

BACKGROUND: Several multicenter random clinical trials have studied a second-generation easy-to-use chlorhexidine local delivery system to assess its effectiveness as an adjunct to scaling and root planing, or SRP. METHODS: The author reviews the pharmacokinetics of the local delivery system and two of the multicenter randomized clinical trials. One study evaluated 118 patients using split-arch design and the other study 447 patients using parallel design. All patients underwent SRP. Test sites, which had pocket depths of 5 millimeters or larger, received a chlorhexidine chip (in both studies) or a placebo chip (the parallel study only). Test sites that remained 5 mm or larger were re-treated with a chip at three months and at six months (parallel study only). RESULTS: Both studies found greater mean reductions in probing depth when the chlorhexidine chip was used in conjunction with SRP than when SRP was used alone (1.16 mm vs. 0.7 mm, P < or = .0001, in the split-arch-design study and 0.95 mm vs. 0.65 mm, P = .00001, in the parallel-design study). The combined therapy resulted in significantly more sites with probing depth reductions of 2 mm or more compared with SRP alone (49.5 percent vs. 32.1 percent; P < .0001, in the split-arch-design study and 19.1 percent vs. 8 percent, P < .0001, in the parallel-design study). CONCLUSIONS: Use of the chlorhexidine chip has significantly improved the clinical parameters of periodontitis when used as an adjunct to SRP. CLINICAL IMPLICATIONS: When used with SRP, the chlorhexidine chip offers the clinician a new method of achieving and maintaining periodontal stability.

Effect of brushing with sonic and counterrotational toothbrushes on the bond strength of orthodontic brackets.

The purpose of this study was to evaluate the effect of brushing with both a sonic and mechanical counter rotary power toothbrush on the bond strength of orthodontic brackets. Forty-five extracted teeth were divided into three random groups and had orthodontic brackets bonded to them. One group was brushed with a counterrotational toothbrush, the Interplak, one group with a sonic toothbrush, the Sonicare, and a third group was not brushed and was held as a control. After the equivalent of 2 years brushing, the teeth were placed in an Instron machine and the shear force to remove the brackets was recorded. Group 1, the counter rotary power brush, had a mean of 107.5 kg/cm2, the second group, the sonic brush, had a mean of 79.7 kg/cm2, and the control group had a mean of 125. 4 kg/cm2. Single factor analysis of variance followed by the Fisher-Hayter Multiple Comparison Procedure showed a statistically significant difference between the sonic power brush and the control (P <.01), but no significant difference between the counter rotary and the control (P >.05). There was no significant difference between the two power brushes (P >.05).

Local delivery of antimicrobials: a new era in the treatment of adult periodontitis.

This article discusses the principles, products, and techniques currently available for local delivery of antimicrobials in the treatment of adult periodontitis. Four principles provide the scientific basis for the treatment of periodontitis: it is caused by bacteria; it cannot be cured, but it can be controlled; clinicians cannot remove all the plaque and calculus; and periodontitis reinfects. This article stresses how the local delivery of antimicrobials can help the clinician achieve the goals of arresting the disease and maintaining the disease in the arrested or controlled state. Rationales for reevaluating the treated patient and treatment options are presented. Local-delivery systems are reviewed, stressing those available in the United States. Pharmacokinetics, multicenter randomized trials, and techniques are presented.

A new horizon for the dental hygienist: controlled local delivery of antimicrobials.

All drugs and controlled local delivery systems must be approved by the Food and Drug Administration (FDA) prior to being marketed and used in clinical practice. These systems can only be used in the clinical office setting by the dentist or under his/her supervision. One controlled local antimicrobial delivery system, tetracycline fiber, has been on the market for several years. A second system, chlorhexidine chip, was approved by the FDA in May 1998, and a third system, doxycycline polymer, was approved in September 1998. Local delivery of antimicrobials will significantly change the way periodontitis is treated. Dental hygienists may be key therapists in providing this therapy. This article discusses the science and techniques of the three systems: tetracycline fiber, doxycycline polymer, and chlorhexidine chip. The dental hygienist's role in providing local delivery treatment is stressed. Factors important in selecting the most suitable delivery system are also discussed. This article represents a large portion of the presentation, "The Local Delivery of Antimicrobials in the Treatment of Periodontitis," made at the annual session of the American Dental Hygienists' Association (ADHA) June 27 and 28, 1998.

The use of locally delivered chlorhexidine in the treatment of periodontitis. Clinical results.

Since the advent of a nondegradable controlled local delivery of antibiotics in 1979, several second generation systems have been developed. Second generation systems have attempted to improve on the early system. Chlorhexidine has been used effectively for over 30 years as an antiseptic. In the early 1970s, chlorhexidine gluconate was incorporated at 0.2% into mouthrinses in Europe and in 1986 it was incorporated at 0.12% in a mouthrinse in the United States. Since these mouthrinses were effective in reducing the supragingival flora, had a high safety margin, and had no reported bacterial resistance, chlorhexidine offered a therapeutic advantage for a local delivery system. This system was developed and studied. This report will discuss this new biodegradable system containing chlorhexidine gluconate as the active agent (PerioChip). Pharmacokinetics of the system and a review of the multicenter studies in Europe and the United States are discussed. In these randomized clinical trials the chlorhexidine chip has been shown to enhance the effects of scaling and root planing. Chlorhexidine chip in conjunction with scaling and root planing, when compared to scaling and root planing alone, has shown significant improvement in probing pocket depth reduction, probing attachment level and bleeding on probing. This delivery system, in combination with scaling and root planing, has also resulted in significantly more probing depth reductions of 2 mm or more. The system is safe and efficacious. Placement of the chip is usually done in less than 1 min, it requires no retention system, biodegrades, and does not require a follow-up dental appointment.

Effect of brushing with sonic and counterrotational toothbrushes on the bond strength of full veneer crowns.

STATEMENT OF PROBLEM: Earlier studies on orthodontic brackets have shown a loss of bond strength after a sonic toothbrush was used. PURPOSE: This in vitro study evaluated the difference in bond strength of single complete veneer crowns after being subjected to the equivalent of 2 years of brushing with sonic and counterrotational toothbrushes. MATERIAL AND METHODS: Complete gold crowns were fabricated with a conventional indirect technique for 30 extracted, intact, prepared human premolar teeth. Castings were then luted to the teeth with glass ionomer cement. Teeth were randomly divided into 3 groups of 10 teeth each, 1 group to be brushed with Sonicare sonic toothbrush, 1 group to be brushed with Interplak counterrotational mechanical toothbrush, and 1 group as the control. Groups 1 and 2 were then brushed for the equivalent of 2 years per tooth. A uniform force of 50 g for the sonic toothbrush and 120 g for the counterrotational toothbrush was used. Control specimens were not brushed. Brush heads and sample teeth in contact with the toothbrush were kept moist at all times. Tensile dislodgment force was determined with an Instron universal testing machine. RESULTS: The castings brushed with a sonic toothbrush required a mean of 43.22 kg (+/- 11.16) force to remove the crowns from the teeth, whereas the counterrotational group required a mean of 42.87 kg (+/- 10.42) and the control group a mean of 42.12 kg (+/- 6.61). Analysis of variance on the force data indicated no differences among the 3 groups in the force needed to remove the castings (F[2,24] = 0.031, P = .97). CONCLUSION: This in vitro study demonstrated no significant differences between groups in the amount of tensile dislodgment force required to remove cemented full veneer crowns from prepared teeth after brushing for the equivalent of 2 years time with a sonic toothbrush or a counterrotational toothbrush.

Chemical treatment of periodontitis: local delivery of antimicrobials.

Periodontitis is a bacterial infection. It appears in a generalised form but more often appears in local areas in a patient's mouth or is reduced to localised areas by mechanical treatment. Periodontitis lends itself well to treatment by means of a controlled local delivery system using an antimicrobial agent. Several products have been introduced or are in the process of clearing regulatory agencies. It is the goal of all local delivery systems to deliver high concentrations of an antimicrobial directly to the site of the periodontal infection. Concentrations of medication can be achieved considerably higher than could be obtained with systemic administration, while the systemic uptake of the medication is minimal. Five local delivery systems (tetracycline fibre, doxycycline polymer, chlorhexidine chip, minocycline ointment and metronidazole gel) are now available. Techniques for their use and the supporting scientific evidence are presented and indications for the use of the various systems are also discussed. These local delivery systems offer the clinician additional therapeutic procedures to aid in the treatment of the chronic inflammatory periodontal diseases.

Adjunctive use of a subgingival controlled-release chlorhexidine chip reduces probing depth and improves attachment level compared with scaling and root planing alone.

The present studies evaluated the efficacy of a controlled-release biodegradable chlorhexidine (CHX) (2.5 mg) chip when used as an adjunct to scaling and root planing on reducing probing depth (PD) and improving clinical attachment level (CAL) in adult periodontitis. Two double-blind, randomized, placebo-controlled multi-center clinical trials (5 centers each) were conducted; pooled data are reported from all 10 centers (447 patients). At baseline, following 1 hour of scaling and root planing (SRP) in patients free of supragingival calculus, the chip was placed in target sites with PD 5 to 8 mm which bled on probing. Chip placement was repeated at 3 and/or 6 months if PD remained > or = 5 mm. Study sites in active chip subjects received either CHX chip plus SRP or SRP alone (to maintain study blind). Sites in placebo chip subjects received either placebo chip plus SRP or SRP alone. Examinations were performed at baseline; 7 days; 6 weeks; and 3, 6, and 9 months. At 9 months significant reductions from baseline favoring the chlorhexidine chip compared with both control treatments were observed with respect to PD (chlorhexidine chip plus SRP, 0.95 +/- 0.05 mm; SRP alone, 0.65 +/- 0.05 mm, P < 0.001; placebo chip plus SRP, 0.69 +/- 0.05 mm, P < 0.001) and CAL (chlorhexidine chip plus SRP, 0.75 +/- 0.06 mm; SRP alone, 0.58 +/- 0.06 mm, P < 0.05; placebo chip plus SRP, 0.55 +/- 0.06 mm, P < 0.05). The proportion of patients who evidenced a PD reduction from baseline of 2 mm or more at 9 months was significantly greater in the chlorhexidine chip group (19%) compared with SRP controls (8%) (P < 0.05). Adverse effects were minor and transient toothache, including pain, tenderness, aching, throbbing, soreness, discomfort, or sensitivity was the only adverse effect that was higher in the chlorhexidine group as compared to placebo (P = 0.042). These data demonstrate that the adjunctive use of the chlorhexidine chip results in a significant reduction of PD when compared with both SRP alone or the adjunctive use of a placebo chip. These multi-center randomized control trials suggest that the chlorhexidine chip is a safe and effective adjunctive chemotherapy for the treatment of adult periodontitis.

The effects of an ultrasonic toothbrush on plaque accumulation and gingival inflammation.

The purpose of this study was to evaluate the effectiveness of an ultrasonic toothbrush to reduce plaque and gingival inflammation when compared to a manual toothbrush. 62 healthy adult patients with a plaque index of at least 2.0, a 50% bleeding index and at least 16 natural teeth participated in this study. 31 patients were randomly assigned to the manual toothbrush group (group A) and 31 were assigned to an ultrasonic toothbrush group (group B). The Turesky et al. plaque index (PI), Eastman bleeding index, and Loe & Silness gingival index (GI) were performed at baseline, 15, and 30 days at the beginning of each appointment (pre-brushing). Patients then brushed with their assigned toothbrush and a post-brushing plaque index was recorded. Kruskal-Wallis one-way analysis of variance (ANOVA) was performed to determine between group differences on the parameters of all clinical indices. Results of the pre-brushing plaque index in group B were significantly lower at 15 and 30 days compared to group A. The post-brushing plaque index demonstrated no statistically significant between or within group differences. Both groups demonstrated significant within group reductions in GI and BI from baseline to 15 days and from 15 to 30 days, however, no between group differences were noted. The results of this study support the ability of an ultrasonic toothbrush to significantly remove plaque and reduce inflammation as well as a manual toothbrush over a 30 day period.

Controlled local delivery of antimicrobials in the treatment of periodontitis.

Five local delivery systems with five different antimicrobial agents have been discussed. All are capable of delivering high concentrations of their antimicrobial to the site of the periodontal infection. Although only one system, tetracycline fiber, is available in United States, two other systems, chlorhexidine chip and doxycycline polymer, may be available in the near future. Two other systems, metronidazole gel and minocycline ointment, are available in other countries. Data from pertinent studies were presented as were techniques for using the various systems. Indications for the use of the products were also discussed. In selecting the appropriate delivery system, the clinician has to weigh the efficacy of the products, ease of use, availability, and cost. Although local delivery systems do not replace existing periodontal therapies, they do have a place in the treatment of periodontitis and offer the dentist additional methods to aid in the control of periodontal diseases.

The time and ease of placement of the chlorhexidine chip local delivery system.

The first local delivery system for an antimicrobial agent was a nondegradable tetracycline-impregnated fiber introduced by Goodson et al in 1979. PerioChip, a biodegradable chip containing chlorhexidine, was recently approved by the Food and Drug Administration for the treatment of adult periodontitis. During several multicenter randomized clinical trials, this product, when used as an adjunct to scaling and root planing, was found to reduce probing depth and improve attachment level significantly more than scaling and root planing alone.

Laser irradiation of bone. I. An in vitro study concerning the effects of the CO2 laser on oral mucosa and subjacent bone.

The purpose of this study was twofold: first, to evaluate the histologic effects of CO2 laser irradiation on biopsies of porcine oral mucosa and underlying bone under conditions that simulate the applications of the laser during gingival surgery; and second, to evaluate the histologic effects on cortical bone following irradiation with increasing energy densities. Specimens consisting of mucosa and underlying bone were subjected to multiple passes of the laser beam in the same line of incision at energy densities ranging from 240 to 1,032 J/cm2. A second group of specimens consisting only of cortical bone was irradiated by a single pass of the laser at energy densities ranging from 40 to 2,062 J/cm2. In both groups the mean depth of ablation, width of surface damage, and widths of the zones of thermal necrosis and thermal damage were determined. Results showed a direct correlation between increasing energy density and/or number of energy beam passes and increasing depths of ablation and widths of surface damage. Further, more than three passes at 1,032 J/cm2 penetrated the mucosal layer to involve underlying bone. The mean depth of ablation for bone specimens following a single pass of the energy beam ranged from 0.02 mm at 160 J/cm2 to a maximum of 0.75 mm at 2,062 J/cm2. Using those energy densities most common to oral soft tissue surgery, the mean depth of ablation in bone specimens ranged from 0.17 mm at 240 J/cm2 to 0.28 mm at 640 J/cm2 to 0.35 mm at 1,032 J/cm2. All specimens regardless of tissue composition, energy density, or number of energy beam passes exhibited a distinct layer of residual carbonized tissue, a zone of thermal necrosis characterized by tissue coagulation, and a zone of tissue exhibiting thermal damage.

Histologic evaluation of soft tissue attachment to CO2 laser-treated root surfaces: an in vivo study.

There is little support in the dental literature to justify the use of lasers for periodontal root therapy. To the contrary, there are several in vitro studies suggesting potentially adverse effects when lasers are applied to root surfaces. The purpose of this study was to evaluate, in vivo, soft tissue attachment to root surfaces following CO2 laser irradiation. Using a four-quadrant design with one quadrant serving as an untreated control, the remaining quadrants in each of two dogs were treated by (1) scaling and root planing, (2) laser only, and (3) laser followed by scaling and root planing. Prior to the assigned treatments, the roots of three teeth in each quadrant (including the control) were exposed by flap reflection and ostectomy. After root therapy the flaps were repositioned and allowed to heal for 28 days. Clinical attachment levels were determined prior to surgery, at 28 days, and by histologic measurement. Results indicate that specimens treated with laser only lost attachment compared to controls and other treatment groups. Furthermore, there was no histologic evidence of soft tissue attachment to a laser-treated surface that featured a residual char layer.

Multi-center comparative evaluation of subgingivally delivered sanguinarine and doxycycline in the treatment of periodontitis. I. Study design, procedures, and management.

The design and conduct of a 9-month multi-center clinical trial to evaluate the safety and efficacy of subgingivally delivered 5% sanguinarium chloride (SC) and 10% doxycycline hyclate (DH) from a biodegradable drug delivery system in the treatment of adult periodontitis is described. The 3-group randomized study of 180 adults with moderate to severe periodontitis was a modified double-blind parallel design. One group received DH, one group received SC, and the other group received the vehicle control (VC). Patients selected had two quadrants with a minimum of four periodontal pockets > or = 5 mm in depth with two sites > or = 7 mm. All qualifying sites exhibited bleeding on gentle probing. Qualifying sites were treated at baseline and again at 4 months. Clinical response was assessed by measuring attachment level, probing depth, and bleeding on probing at monthly examinations at qualifying sites and the entire dentition. The plaque index was measured monthly to verify oral hygiene status. The parallel design afforded the opportunity to distinguish between treatment effectiveness of SC, DH, and VC independent of possible crossover effects. Also the effectiveness of oral hygiene in untreated sites of the mouth could be evaluated. Finally, treatment effects in moderate (5 to 6 mm) and deep (> or = 7 mm) pockets in both treated and untreated sites could be compared. The design was capable of simulating a periodontal practice maintenance program and assessing the response according to maintenance and treatment history. Study management procedures that emphasized center examiner and therapist training and adherence to protocol and procedures to reduce variability are described.

Multi-center comparative evaluation of subgingivally delivered sanguinarine and doxycycline in the treatment of periodontitis. II. Clinical results.

The clinical safety and effectiveness of a subgingivally delivered biodegradable drug delivery system containing either 10% doxycycline hyclate (DH), 5% sanguinarium chloride (SC) or no agent (VC) was evaluated in a 9-month multi-center trial. The study was a randomized parallel design with 180 patients who demonstrated moderate to severe periodontitis. All patients had at least two quadrants with a minimum of four qualifying pockets > or = 5 mm that bled on probing. Two of the qualifying pockets were required to be > or = 7 mm. At baseline and at 4 months all qualified sites were treated with the test article administered via syringe. Probing depth reduction (PDR), attachment level gain (ALG), bleeding on probing reduction (BOP), and plaque index were determined monthly. Analysis of efficacy data from the 173 efficacy-evaluable patients indicated that all treatments gave significant positive clinical changes from baseline at all subsequent timepoints. DH was superior to SC and VC in PDR at all timepoints (P < or = 0.01 to 0.001) with a maximum reduction of 2.0 mm at 5 months. For ALG, DH was superior to VC at months 2, 3, 4, 5, 6, 8, and 9 (P < or = 0.04 to 0.002) and superior to SC at months 5, 6, 7, 8, and 9 (P < or = 0.01 to 0.001) with a maximum ALG of 1.2 mm at 6 months. For BOP reduction, DH was superior to VC at all time points (P < or = 0.05) and to SC at months 3, 5, 6, 8, and 9 (P < or = 0.03). For DH, the maximum ALG in deep (> or = 7 mm) pockets was 1.7 mm and PDR 2.9 mm compared to 0.8 mm and 1.6 mm, respectively for moderate (5 to 6 mm) pockets. Test articles were applied without anesthesia and no serious adverse events occurred in the trial. The results of this study indicate that 10% doxycycline hyclate delivered in a biodegradable delivery system is an effective means of reducing the clinical signs of adult periodontitis and exhibits a benign safety profile.