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OpenTrials
Completed

NCT Number: NCT01098448

Control of Periodontal Infections

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Forsyth Institute

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Scaling and root planing

Other

scaling and root planing as a single therapy

local tetracycline

Drug

local delivery of tetracycline fibers releasing approximately 1.7 mg/tooth in all pockets >5mm

systemic metronidazole and amoxicillin

Drug

systemic metronidazole (250 mg tid x 14) and amoxicillin (500 mg bid x 14

SURGERY

Other

periodontal surgery in residual pockets of >4mm

local antibiotics and systemic metronidazole and amoxicillin

Drug

1.7 mg/tooth tetracycline fiber plus metronidazole (250 mg tid x14d)and amoxicillin (500 mg bid x 14d)

local tetracycline and periodontal surgery

Other

local delivery of tetracycline fibers releasing approximately 1.7 mg/tooth in all pockets >5mm and periodontal surgery in residual pockets of >4mm

periodontal surgery and systemic metronidazole and amoxicillin

Other

surgery in residual pockets >4mm and metronidazole (250mg tidx14d) and amoxicillin (500mg bidx14d)

surgery, local tetracycline, systemic metronidazole and amoxicillin

Other

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)

Primary outcomes

  1. Clinical Attachment Level Gain

    Time frame: 24 months

Secondary outcomes

  1. Probing pocket depth reduction

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

The Forsyth Institute

Other

Collaborators

  • Boston University
  • Göteborg University

Registry information

Important dates

Study start
1999
Primary completion
2004
Study completion
2004
First posted
Apr 2, 2010
Registry last updated
Apr 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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