Control of Periodontal Infections

Study Overview
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Brief Summary
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The purpose of this study is to test combined effects of scaling and root planing with periodontal surgery, systemically administered amoxicillin and metronidazole, and/or local tetracycline on pocket depth reduction and attachment level gain in patients with chronic periodontitis.

Detailed Description
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In this 2x2x2 factorial design study, 229 moderate to advanced chronic periodontitis patients stratified according to current smoking status were recruited in USA and Sweden. Patients were randomly assigned to 8 groups, all of which were treated by SRP plus none, one, two or three adjunctive treatments. Thus, patients were assigned to groups that did or did not receive Surg, LAb, SAb or LAb+SAb (All) providing 8 treatment combinations (Surg + All, Surg + SAb, Surg + LAb, Surg alone, SRP + All, SRP + SAb, SRP + LAb, SRP alone). Clinical, microbiological and immunological measurements were taken for 2 years (at baseline, 3, 6, 12, 18 and 24 months). To focus on changes diseased sites, analysis was restricted to sites with baseline pocket depth greater than 5 mm. (also, these were the only sites treated by LAb). In this report, main effects and interactions were evaluated for PD reduction and AL gain two years post therapy for 187 of patients. Mean values were computed for each treatment group and averages after 2 years were compared to baseline by ANOVA. Factorial ANCOVA was used to examine significance of differences between Surg or not, SAb or not and LAb or not for PD reduction and AL gain using baseline attachment level or pocket depth as covariates and including current smoking as a factor.

Official Title
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Control of Periodontal Infections

Conditions
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Periodontitis

Intervention / Treatment
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* Other: scaling and root planing
* Drug: local tetracycline
* Drug: systemic metronidazole and amoxicillin
* Other: surgery
* Drug: local antibiotics and systemic metronidazole and amoxicillin
* Other: local tetracycline and periodontal surgery
* Other: periodontal surgery and systemic metronidazole and amoxicillin
* Other: surgery, local tetracycline, systemic metronidazole and amoxicillin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: greater than 20 years of age had a least 15 natural teeth in good general health at least 4 teeth with pockets > 6 mm at least 8 teeth with AL > 3 mm at baseline Exclusion Criteria: pregnant or nursing (if female) having antibiotic or periodontal therapy in the previous three months systemic conditions that would affect the course of periodontal disease systemic conditions that required antibiotic coverage allergic to drugs used in the study

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Scaling and root planing<br>scaling and root planing as a solo therapy | Other: scaling and root planing<br>* scaling and root planing as a single therapy<br>|
| Experimental: Periodontal surgery<br> | Other: surgery<br>* periodontal surgery in residual pockets of >4mm<br>|
| Experimental: systemic antibiotics<br> | Drug: systemic metronidazole and amoxicillin<br>* systemic metronidazole (250 mg tid x 14) and amoxicillin (500 mg bid x 14<br>|
| Experimental: Local delivery of tetracycline<br> | Drug: local tetracycline<br>* local delivery of tetracycline fibers releasing approximately 1.7 mg/tooth in all pockets >5mm<br>|
| Experimental: local antibiotic and systemic antibiotics<br> | Drug: local antibiotics and systemic metronidazole and amoxicillin<br>* 1.7 mg/tooth tetracycline fiber plus metronidazole (250 mg tid x14d)and amoxicillin (500 mg bid x 14d)<br>|
| Experimental: local antibiotics and surgery<br> | Other: local tetracycline and periodontal surgery<br>* local delivery of tetracycline fibers releasing approximately 1.7 mg/tooth in all pockets >5mm and periodontal surgery in residual pockets of >4mm<br>|
| Experimental: systemic antibiotics and surgery<br> | Other: periodontal surgery and systemic metronidazole and amoxicillin<br>* surgery in residual pockets >4mm and metronidazole (250mg tidx14d) and amoxicillin (500mg bidx14d)<br>|
| Experimental: local and systemic antibiotics and surgery<br> | Other: surgery, local tetracycline, systemic metronidazole and amoxicillin<br>* periodontal surgery in residual pockets >4mm, tetracycline ibers releasing approximately 1.7 mg/tooth in pockets >5mm, systemic metronidazlo (250mg tidx14d) and amoxicillin (500 mg bidx14d)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Attachment Level Gain |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing pocket depth reduction |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amoxicillin, antibiotics, chronic periodontitis, local drug delivery, metronidazol, randomized controlled trial, subgingival scaling, surgery, tetracycline, moderate to advanced chronic periodontitis