Control of Periodontal Infections

The Forsyth Institute

Status and phase: Completed; Phase 3

Conditions: Periodontitis

Treatments: Other: scaling and root planing; Other: surgery, local tetracycline, systemic metronidazole and amoxicillin; Other: surgery; Drug: local tetracycline; Other: local tetracycline and periodontal surgery; Drug: local antibiotics and systemic metronidazole and amoxicillin; Drug: systemic metronidazole and amoxicillin; Other: periodontal surgery and systemic metronidazole and amoxicillin

Study type: Interventional

Funder types: Other

Identifiers

NCT01098448

NIDCR-012861

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 187 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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187 participants in 8 patient groups

Scaling and root planing

Active Comparator group

Description:

scaling and root planing as a solo therapy

Treatment:

Other: scaling and root planing

Periodontal surgery

Experimental group

Treatment:

Other: surgery

systemic antibiotics

Experimental group

Treatment:

Drug: systemic metronidazole and amoxicillin

Local delivery of tetracycline

Experimental group

Treatment:

Drug: local tetracycline

local antibiotic and systemic antibiotics

Experimental group

Treatment:

Drug: local antibiotics and systemic metronidazole and amoxicillin

local antibiotics and surgery

Experimental group

Treatment:

Other: local tetracycline and periodontal surgery

systemic antibiotics and surgery

Experimental group

Treatment:

Other: periodontal surgery and systemic metronidazole and amoxicillin

local and systemic antibiotics and surgery

Experimental group

Treatment:

Other: surgery, local tetracycline, systemic metronidazole and amoxicillin