A M Polson

University of Pennsylvania, Philadelphia, Pennsylvania, United States

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Publications (119)270.33 Total impact

  • [Show abstract] [Hide abstract]
    ABSTRACT: Previous studies showed that adjunctive subantimicrobial dose doxycycline (SDD; 20 mg, twice daily) provides significant clinical benefits to scaling and root planing (SRP). A modified-release SDD formulation containing 40 mg doxycycline (SDD-40) to be taken once daily has been developed. The aim of this study was to investigate the efficacy of SDD-40 when used as an adjunct to SRP for the treatment of periodontitis. A 9-month, double-masked, randomized, placebo-controlled, multicenter study was conducted to test the efficacy of adjunctive SDD-40 in 266 subjects with periodontitis. Subjects were treated by SRP and randomized to receive SDD-40 or placebo for 9 months with evaluations at 3, 6, and 9 months. Adjunctive SDD-40 provided significantly greater clinical benefits than placebo at all time points. At month 9, at sites with baseline probing depths (PD) > or =6 mm, 72% to 76% of sites in the SDD-40 group demonstrated clinically significant PD reductions and clinical attachment level (CAL) gains > or =2 mm compared to 56% to 58% of sites in the placebo group (P <0.0001); 48% to 52% of sites in the SDD-40 group demonstrated PD reductions and CAL gains > or =3 mm compared to 32% of sites in the placebo group (P <0.0001). In moderate sites (baseline PD 4 to 6 mm), adjunctive SDD-40 provided significant clinical benefits compared to placebo for mean CAL (all time points: P <0.05), PD (3 months: P = 0.002; 6 and 9 months: P = 0.001), and bleeding on probing (BOP) (3 months: P <0.01; 6 months: P <0.02; 9 months: P <0.05). In deep sites (baseline PD > or =7 mm), SDD-40 provided significant benefits over control for mean CAL (3 months: P <0.05; 6 and 9 months: P <0.01), PD (all time points: P <0.001), and BOP (3 months: P <0.05; 6 months: not statistically significant; 9 months: P <0.05). Compliance with study medication was high (>92%) with no significant differences in adverse events between groups and no evidence of microbiologically significant changes or development of antibiotic resistance in the subgingival flora in either group. SDD-40 used as an adjunct to SRP resulted in significantly greater clinical benefits than SRP alone in the treatment of periodontitis.
    Journal of Periodontology 04/2008; 79(3):440-52. · 2.40 Impact Factor
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    ABSTRACT: Previous studies showed that host modulation therapy (HMT) or topical antimicrobial therapy (TAT) provided significant adjunctive benefits to scaling and root planing (SRP) in the treatment of chronic periodontitis (CP). The purpose of this study was to evaluate a combination therapy involving SRP, HMT, and TAT in the treatment of moderate to severe CP. A 6-month, randomized, multicenter, placebo-controlled, examiner-masked study was undertaken to evaluate the clinical usefulness of a combination treatment of systemically delivered doxycycline hyclate (HMT; 20 mg, twice a day) plus locally delivered doxycycline hyclate gel (TAT; 10%, in pockets > or =5 mm) in combination with SRP versus SRP plus placebo. Clinical outcomes included mean changes in probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), and gingival index (GI) at baseline and at 3 and 6 months. In 171 subjects, combination therapy provided significantly greater clinical benefits than control therapy for all clinical measures at 3 and 6 months. In moderate CP (PD of 4 to 6 mm), combination therapy provided significant benefits over control for PD (3 and 6 months: P <0.01), CAL (3 months: P <0.01; 6 months: P <0.03), BOP (3 months: P <0.02; 6 months: P <0.05), and GI (3 months: P <0.01; 6 months: P <0.03). In severe CP (PD > or =7 mm), combination therapy provided significant benefits over control for PD (3 and 6 months: P <0.01), CAL (3 months: P <0.01; 6 months: P <0.02), BOP (3 months: P <0.01; 6 months: P >0.05), and GI (3 months: P <0.01; 6 months: P <0.01). Combination therapy, including SRP, HMT, and TAT, provided significantly greater clinical benefits than SRP alone in the treatment of moderate to severe CP.
    Journal of Periodontology 01/2008; 79(1):33-41. · 2.40 Impact Factor
  • Journal Of Clinical Periodontology 01/2008; 28(12):1115-1120. · 3.69 Impact Factor
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    ABSTRACT: Several studies reported some success toward regeneration in infrabony defects using enamel matrix derivative (EMD). Clinically and statistically significant improvements in probing depth reduction, clinical attachment levels, and bone fill have been demonstrated. This multi-center study evaluated the potential for sensitization to EMD in a subgroup of periodontal patients treated at least twice with at least 2 months between treatments. Three hundred seventy-six (376) patients in 11 university-based postgraduate periodontics programs and five private practices were selected. Surgeries were performed on infrabony defects. Following reflection of mucoperiosteal flaps and debridement of the root surface and defect, root conditioning (either citric acid pH = 1 or 24% EDTA) was performed and the site was irrigated with sterile saline. Enamel matrix derivative was reconstituted and applied to the exposed root surface and the bony defect. Flaps were sutured and pressure applied for 5 minutes. The second test defect was treated in a similar manner at least 8 weeks after the first surgery. The patient was given a diary card where any subjective adverse events (erythema, swelling, itching, headache, root hypersensitivity, or pain) were recorded at weeks 1 and 2 post-surgery. In addition, objective adverse events (gingival inflammation, ulcers, abscess, cratering, and lesions) were recorded by the investigator on an adverse event form. No clinical adverse reactions to multiple applications of EMD were noted. Of 376 patients, two were referred to a dermatologist for evaluation, but neither had signs indicating any adverse events due to EMD treatment. Instead their reactions were classified as a small local abscess and tinea cruris. The single immunoassay performed (on the patient with a small local abscess) did not demonstrate any EMD-reactive antibodies, neither IgE nor IgG. Other subjective/objective reactions that occurred during this study were of the type that are commonly experienced by patients immediately following periodontal surgery, but were not related to EMD. They included headache, swelling, itching, pain, and root hypersensitivity. This study demonstrated a lack of clinical adverse reactions following two separate applications of EMD. Any subjective/objective adverse reactions experienced by the patient were typical complications following routine periodontal surgery and were not directly related to the use of enamel matrix derivative.
    Journal of Periodontology 08/2004; 75(7):1001-8. · 2.40 Impact Factor
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    ABSTRACT: This paper examines the effects of smoking on the treatment outcomes of two nonsurgical therapies: (1) scaling and root planing alone (SRP) or (2) controlled-release of subgingivally delivered doxycycline hyclate in a polylactic acid based polymer gel. Subjects from 2 9-month multicenter studies were classified as nonsmokers (never smoked: 100 subjects), former smokers (137 subjects), and current smokers (≥10 cigarettes/day: 121 subjects). Clinical parameters were analyzed for treated sites with baseline probing depths ≥5 mm and for a subset of treated sites with baseline probing depths of ≥7 mm. Clinical parameters (plaque levels, clinical attachment levels, pocket depths, and bleeding on probing) were analyzed at baseline, 4, 6, and 9 months. In the doxycycline treated group in general, there were neither marked significant differences in clinical attachment gain nor differences in probing depth reduction among the 3 smoking groups. On the other hand, in the scaling and root planing treated group in general, there were significant differences in clinical attachment gain and pocket depth reduction, with non-smokers responding better than former smokers and current smokers at 6 and 9 months. These differences in clinical response between scaling and root planing alone versus controlled-release of locally-delivered doxycycline hyclate among these 3 smoking groups are discussed in relation to treatment implications for smokers.
    Journal Of Clinical Periodontology 10/2003; 26(10):683 - 691. · 3.69 Impact Factor
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    ABSTRACT: The effect of subgingival calculus on the clinical outcomes of the local delivery of antimicrobials is unknown. This study examines the clinical outcomes of treatment with locally delivered controlled-release doxycycline (DH) or scaling and root planing (SRP) in subsets of adult periodontitis patients with known baseline levels of subgingival calculus. The data examined were obtained from 393 patients who participated in 2 multi-center trials. All patients had baseline subgingival calculus levels assessed and were then treated at baseline and month 4 with either DH or SRP. Clinical attachment levels (CAL), pocket depth (PD) and bleeding on probing (BOP) were assessed at baseline and months 1, 2, 4, 5, 6, 8 and 9. Treatment with either DH or SRP resulted in significant statistical and clinical improvements in CAL, PD and BOP. These clinical outcomes were equivalent regardless of the extent of subgingival calculus present at baseline. The results indicate that the primary clinical effects of these therapies are the result of a disruption and reduction of the subgingival plaque and not the effect of the removal of subgingival calculus and contaminated cementum.
    Journal Of Clinical Periodontology 03/2002; 29(2):87-91. · 3.69 Impact Factor
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    ABSTRACT: The purpose of this retrospective analysis was to examine what effect, if any, the time elapsed between an individual's last episode of scaling and root planing and subsequent treatment with a sustained-release doxycycline hyclate gel (DH) alone or scaling and root planing alone (SRP) would have upon adult periodontitis. A total of 207 subjects were included in the DH group and 210 patients in the SRP group. Periodontitis was defined as those sites which presented with pocket depths > or =5 mm and exhibited bleeding upon probing. In both DH and SRP groups, 3 sub-groups of subjects were identified according to their last episode of scaling and root planing prior to the study baseline: within 2 to 6 months, >6 but < or =12 months, and one or more times in their life but not within the last 12 months. Each study site was treated twice over a 9-month study period, once at baseline and again at 4 months. Data from the study sites at 4, 6, and 9 months were then evaluated for changes in probing depth, clinical attachment level, and bleeding upon probing. At the 9-month evaluation, all sub-groups in the DH and SRP treatment arms presented with improvement in the measured clinical parameters, as compared to baseline. No significant differences were observed in the measured periodontal indices among the study sites between the three sub-groups for either treatment. It is concluded that the time interval since the last episode of scaling and root planing had no observable effect on the results achieved when treating periodontitis sites with locally delivered doxycycline hyclate alone or scaling and root planing alone. The treatment of periodontitis sites with locally delivered doxycycline hyclate resulted in clinical improvement comparable to scaling and root planing irrespective of the patient's prophylaxis frequency.
    Journal Of Clinical Periodontology 12/2001; 28(12):1115-20. · 3.69 Impact Factor
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    ABSTRACT: Subantimicrobial dose doxycycline (SDD 20 mg bid) plus scaling and root planing (SRP) significantly improved clinical attachment level (CAL) and reduced probing depth (PD) compared with placebo plus SRP in a double-blind, placebo-controlled, multicenter study of patients with adult periodontitis (AP). In a study conducted as a follow-up, the post-treatment effects of SDD were assessed in patients who completed the SRP study. The SRP study was a 9-month, active-treatment study and the follow-up was a 3-month, no-treatment study. In the SRP study, tooth sites in qualifying quadrants were scaled and root planed and patients were randomized to receive twice daily SDD 20 mg or placebo. In the follow-up, patients received no study drug; investigators and patients remained blinded to the previous treatment group assignments. Efficacy measures included the change in CAL and PD from baseline values determined at the start of the SRP study in tooth sites stratified by baseline PD (i.e., 0-3 mm, 4-6 mm, > or =7 mm). Safety was evaluated using adverse event data and the results of clinical laboratory tests, oral pathology examinations, and microbiological assessments. Within each disease stratum, the incremental improvements in PD and CAL demonstrated in the SDD group over 9 months of active treatment were maintained through 3 additional months of no treatment. Treatment cessation did not result in an accelerated regression of periodontal health. No differences in the incidence of adverse events (including those related to infection) or laboratory or microbiological parameters were noted between the SDD group and the placebo group. The administration of SDD 20 mg bid for a period of up to 9 months is not associated with rebound effects or delayed or negative after-effects for a 3-month period after cessation of therapy.
    Journal Of Clinical Periodontology 09/2001; 28(8):782-9. · 3.69 Impact Factor
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    ABSTRACT: In a previous study, subantimicrobial dose doxycycline (SDD) significantly improved clinical parameters associated with periodontal health in patients with adult periodontitis (AP) when used as an adjunct to a maintenance schedule of supragingival scaling and dental prophylaxis. In this double-blind, placebo-controlled, parallel-group, multicenter study, the efficacy and safety of SDD were evaluated in conjunction with scaling and root planing (SRP) in patients with AP. Patients (n = 190) received SRP at the baseline visit and were randomized to receive either SDD 20 mg bid or placebo bid for 9 months. Efficacy parameters included the per-patient mean changes in clinical attachment level (CAL) and probing depth (PD) from baseline, the per-patient percentages of tooth sites with attachment loss (AL) > or = 2 mm and > or = 3 mm from baseline, and the per-patient percentage of tooth sites with bleeding on probing. Prior to analysis, tooth sites were stratified by the degree of disease severity evident at baseline In tooth sites with mild to moderate disease and severe disease (n = 183, intent-to-treat population), improvements in CAL and PD were significantly greater with adjunctive SDD than with adjunctive placebo at 3, 6, and 9 months (all P <0.05). In tooth sites with severe disease, the per-patient percentage of sites with AL > or = 2 mm from baseline to month 9 was significantly lower with adjunctive SDD than with adjunctive placebo (P<0.05). Improvements in clinical outcomes occurred without detrimental shifts in the normal periodontal flora or the acquisition of doxycycline resistance or multiantibiotic resistance. SDD was well tolerated, with a low incidence of discontinuations due to adverse events. The adjunctive use of SDD with SRP is more effective than SRP alone and may represent a new approach in the long-term management of AP.
    Journal of Periodontology 04/2000; 71(4):521-32. · 2.40 Impact Factor
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    ABSTRACT: 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). 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. 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). 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.
    Journal of Periodontology 01/2000; 71(1):22-30. · 2.40 Impact Factor
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    ABSTRACT: Studies have indicated an important role for host-derived proteases in the pathogenesis of periodontal disease. The objectives of this study were: 1) to develop an assay measuring protease activity in situ and 2) to localize and characterize the enzymatic activity in intact inflamed and healthy gingiva. Gingival specimens were prepared and over-laid with a quenched fluorescent substrate. Protease activity was visualized by fluorescence microscopy and correlated with histologic features. In inflamed tissues, enzymatic activity was detected mainly in the connective tissue (predominantly matrix metalloproteases) and, to some extent, in the epithelium (predominantly serine proteases). In contrast, clinically healthy tissues failed to exhibit significant amounts of protease activity. Quantitative and qualitative characteristics of protease activity in intact tissues were found to be pH dependent. The method described here enabled assessment of active proteases in intact tissues where cell-cell and cell-matrix interactions had been maintained. Our results indicate that there are substantial differences in the distribution of specific proteases between clinically healthy and inflamed periodontal tissues.
    Journal of Periodontology 12/1999; 70(11):1303-12. · 2.40 Impact Factor
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    ABSTRACT: This paper examines the effects of smoking on the treatment outcomes of two nonsurgical therapies: (1) scaling and root planing alone (SRP) or (2) controlled-release of subgingivally delivered doxycycline hyclate in a polylactic acid based polymer gel. Subjects from 2 9-month multicenter studies were classified as nonsmokers (never smoked: 100 subjects), former smokers (137 subjects), and current smokers (> or = 10 cigarettes/day: 121 subjects). Clinical parameters were analyzed for treated sites with baseline probing depths > or = 5 mm and for a subset of treated sites with baseline probing depths of > or = 7 mm. Clinical parameters (plaque levels, clinical attachment levels, pocket depths, and bleeding on probing) were analyzed at baseline, 4, 6, and 9 months. In the doxycycline treated group in general, there were neither marked significant differences in clinical attachment gain nor differences in probing depth reduction among the 3 smoking groups. On the other hand, in the scaling and root planing treated group in general, there were significant differences in clinical attachment gain and pocket depth reduction, with non-smokers responding better than former smokers and current smokers at 6 and 9 months. These differences in clinical response between scaling and root planing alone versus controlled-release of locally-delivered doxycycline hyclate among these 3 smoking groups are discussed in relation to treatment implications for smokers.
    Journal Of Clinical Periodontology 11/1999; 26(10):683-91. · 3.69 Impact Factor
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    ABSTRACT: 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. 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. 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. 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.
    Journal of Periodontology 06/1999; 70(5):490-503. · 2.40 Impact Factor
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    ABSTRACT: Biodegradable barrier films were made by coagulating a solution of poly(DL-lactide) in N-methyl-2-pyrrolidone on porous polyethylene pads wetted with saline solution. The semisolid films were cut into 10 x 10 mm barriers and implanted subcutaneously in rabbits. At monthly intervals, the polymer implant sites were compared histologically to those implanted with USP negative control plastic. The polymer films were retrieved from the surrounding tissue, dried, weighed, and the changes in molecular weight determined using gel permeation chromatography. The molecular weight of the polymer decreased at a relatively constant rate over 5 months; however, no significant mass loss occurred until 5 months postimplantation. Also, no distinct histological differences were noted between the polymer barrier and the control plastic sites until 6 months when histiocytes and multinucleated giant cells showed a modest increase around fragmented polymer films. Similar barrier films also were fitted over naturally occurring buccal dehiscence defects in beagle dogs and the tissue sites compared histologically at 6 months to sham-operated control sites. New bone and dense connective tissues closely approximated segments of the remaining polymer and demonstrated the biocompatibility of the biodegradable films. Histomorphometric analyses of treated sites compared to sham controls showed that the polymer barrier is effective in promoting bone and cementum regeneration in periodontal defects in dogs.
    Journal of Biomedical Materials Research 12/1998; 42(2):303-11.
  • L Minsk, A M Polson
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    ABSTRACT: To determine if hormone supplementation reduces the risk of failure for osseointegration of dental implants in postmenopausal women, the treatment outcomes of 116 women older than age 50, treated with 450 endosseous dental implants, were analyzed in this retrospective study. The findings indicated that hormone replacement therapy may not be linked with improved outcomes of endosseous dental implant treatment in postmenopausal women. Smoking, however, appears to significantly increase the implant failure rate in the group observed in this study.
    Compendium of continuing education in dentistry (Jamesburg, N.J.: 1995) 10/1998; 19(9):859-62, 864; quiz 866.
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    G Greenstein, A Polson
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    ABSTRACT: This review article evaluates the role of local drug delivery systems in the management of periodontal diseases. The efficacy of several local delivery devices (i.e., tetracycline fibers, metronidazole and minocycline gels, chlorhexidine chips, and doxycycline polymer) which are either commercially available in the United States or abroad, or are currently under consideration for Food and Drug Administration (FDA) approval are discussed. The drug delivery systems are assessed with regard to their functional characteristics, effectiveness as a monotherapy, as compared to scaling and root planing, and ability to enhance conventional therapy. Furthermore, controversies associated with local delivery are addressed (e.g., induction of bacterial resistant strains, the efficacy of systemic versus local drug delivery, and whether local drug delivery should function as an alternative or as an adjunct to conventional treatment).
    Journal of Periodontology 06/1998; 69(5):507-20. · 2.40 Impact Factor
  • W J Killoy, A M Polson
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    ABSTRACT: 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.
    Dental Clinics of North America 05/1998; 42(2):263-83.
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    ABSTRACT: This multi-center single-blind study compared clinical outcomes following guided tissue regeneration (GTR) treating human Class II furcation defects with a new polylactic-acid-based bioabsorbable barrier (test treatment) or a non-absorbable ePTFE barrier (control treatment). Clinical parameters evaluated were change in vertical attachment level (VAL), horizontal attachment level (HAL), probing depth (PD), and gingival margin location (REC). Surgical treatment resulted in clinically and statistically equivalent changes when comparisons were made between test and control treatments. VAL gain was 2.0 mm for test and 1.6 mm for control groups; HAL gain was 2.1 mm for both test and control groups. PD reduction was 2.3 mm for the test group and 2.1 mm for the control group. Test sites experienced an additional 0.3 mm of recession beyond baseline; control sites, 0.5 mm. Within-group comparisons showed that the amount of recession was not significantly different from baseline in the test group. Recession in the control group was significantly different from baseline. All other parameters in both the test and control groups were significantly different from baseline. Evaluation of safety data indicated no significant differences between test and control treatments, although there was a strong trend for the control group to have more postoperative abscess or suppuration than test sites (control = 11; test = 4; P = 0.06).
    Journal of Periodontology 08/1997; 68(7):667-75. · 2.40 Impact Factor
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    ABSTRACT: THE EFFICACY OF A BIOABSORBABLE polylactic acid based barrier was evaluated using naturally occurring buccal Class II furcation defects in beagle dogs. Sixteen furcation sites (8 control and 8 experimental) were treated in 6 adult animals. After full thickness flap reflection, exposed furcations and root surfaces were thoroughly root planed. In experimental sites a customized barrier was formed and fitted to cover the defect. Surgical flaps were replaced slightly coronal to the cemento-enamel junction. Animals were sacrificed at 6 months and specimens processed for histologic evaluation. Histologic and histometric analyses were done using 6 micrograms step serial sections in the buccal-lingual plane, corresponding to the buccal-lingual extent of the furcation. Results were: mean total defect experimental sites 1.92 mm; control sites 1.47 mm. Mean new cementum formation experimental sites 1.36 mm (71% of initial defect); control sites 0.25 mm (17% of initial defect). Mean new bone formation experimental sites 1.42 mm (74% of initial defect); control sites 0.20 mm (14% of initial defect). Mean junctional epithelium formation experimental sites 0.42 mm (22% of initial defect); control sites 1.21 mm (82% of initial defect). Statistical analysis demonstrated significant differences in all healing parameters favoring experimental (barrier-treated) sites. In this model, regeneration (new bone, cementum, and periodontal ligament) of 71% of the original defect in experimental sites and only 14% in control sites demonstrated a response that highly favored use of the barrier.
    Journal of Periodontology 07/1997; 68(6):536-44. · 2.40 Impact Factor
  • A M Polson
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    ABSTRACT: The present report provides an overview of practical issues related to training, calibrating, and monitoring the individuals involved in conducting a clinical trial. These aspects are considered in relation to a theoretical multi-center clinical trial designed to test the safety and efficacy of a new periodontal treatment. Many factors need to be controlled in order to reduce inherent variability and provide standardization across the study population and study centers in a large-scale multi-center clinical trial. Components incorporated to control these factors include identification and recruitment of study centers, pre-study training and organization of the teams at the different research centers, quality assurance procedures and monitoring of the study for compliance with protocol and safety requirements, and management of databases. Details are given regarding the use of pre-study survey questionnaires to assess research center capabilities, methods for training and calibrating examiners and therapists and methods for integrating these aspects prior to actual study commencement, and quality assurance after the study has begun. The review considers the critical practical details regarding all of these aspects of study organization and execution.
    Annals of Periodontology 04/1997; 2(1):75-82.

Publication Stats

3k Citations
270.33 Total Impact Points

Institutions

  • 1996–2008
    • University of Pennsylvania
      • • Department of Periodontics
      • • School of Dental Medicine
      Philadelphia, Pennsylvania, United States
  • 1998
    • University of Missouri - Kansas City
      • Department of Periodontics
      Kansas City, MO, United States
  • 1997
    • Loma Linda University
      • Department of Periodontics
      Loma Linda, CA, United States
  • 1995
    • University of Colorado
      Denver, Colorado, United States
  • 1988–1989
    • Georgia Health Sciences University
      • Department of Periodontics
      Augusta, GA, United States
    • UCL Eastman Dental Institute
      Londinium, England, United Kingdom
  • 1985
    • Rochester Institute of Technology
      Rochester, New York, United States