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Control of Periodontal Infections

Primary Purpose

Periodontitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
scaling and root planing
local tetracycline
systemic metronidazole and amoxicillin
surgery
local antibiotics and systemic metronidazole and amoxicillin
local tetracycline and periodontal surgery
periodontal surgery and systemic metronidazole and amoxicillin
surgery, local tetracycline, systemic metronidazole and amoxicillin
Sponsored by
The Forsyth Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring Amoxicillin, antibiotics, chronic periodontitis, local drug delivery, metronidazol, randomized controlled trial, subgingival scaling, surgery, tetracycline, moderate to advanced chronic periodontitis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The Forsyth Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Scaling and root planing

Periodontal surgery

systemic antibiotics

Local delivery of tetracycline

local antibiotic and systemic antibiotics

local antibiotics and surgery

systemic antibiotics and surgery

local and systemic antibiotics and surgery

Arm Description

scaling and root planing as a solo therapy

Outcomes

Primary Outcome Measures

Clinical Attachment Level Gain

Secondary Outcome Measures

Probing pocket depth reduction

Full Information

First Posted
April 1, 2010
Last Updated
April 1, 2010
Sponsor
The Forsyth Institute
Collaborators
Göteborg University, Boston University
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1. Study Identification

Unique Protocol Identification Number
NCT01098448
Brief Title
Control of Periodontal Infections
Official Title
Control of Periodontal Infections
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
September 1999 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
December 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The Forsyth Institute
Collaborators
Göteborg University, Boston University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
Amoxicillin, antibiotics, chronic periodontitis, local drug delivery, metronidazol, randomized controlled trial, subgingival scaling, surgery, tetracycline, moderate to advanced chronic periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
187 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Scaling and root planing
Arm Type
Active Comparator
Arm Description
scaling and root planing as a solo therapy
Arm Title
Periodontal surgery
Arm Type
Experimental
Arm Title
systemic antibiotics
Arm Type
Experimental
Arm Title
Local delivery of tetracycline
Arm Type
Experimental
Arm Title
local antibiotic and systemic antibiotics
Arm Type
Experimental
Arm Title
local antibiotics and surgery
Arm Type
Experimental
Arm Title
systemic antibiotics and surgery
Arm Type
Experimental
Arm Title
local and systemic antibiotics and surgery
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
scaling and root planing
Intervention Description
scaling and root planing as a single therapy
Intervention Type
Drug
Intervention Name(s)
local tetracycline
Intervention Description
local delivery of tetracycline fibers releasing approximately 1.7 mg/tooth in all pockets >5mm
Intervention Type
Drug
Intervention Name(s)
systemic metronidazole and amoxicillin
Intervention Description
systemic metronidazole (250 mg tid x 14) and amoxicillin (500 mg bid x 14
Intervention Type
Other
Intervention Name(s)
surgery
Intervention Description
periodontal surgery in residual pockets of >4mm
Intervention Type
Drug
Intervention Name(s)
local antibiotics and systemic metronidazole and amoxicillin
Intervention Description
1.7 mg/tooth tetracycline fiber plus metronidazole (250 mg tid x14d)and amoxicillin (500 mg bid x 14d)
Intervention Type
Other
Intervention Name(s)
local tetracycline and periodontal surgery
Intervention Description
local delivery of tetracycline fibers releasing approximately 1.7 mg/tooth in all pockets >5mm and periodontal surgery in residual pockets of >4mm
Intervention Type
Other
Intervention Name(s)
periodontal surgery and systemic metronidazole and amoxicillin
Intervention Description
surgery in residual pockets >4mm and metronidazole (250mg tidx14d) and amoxicillin (500mg bidx14d)
Intervention Type
Other
Intervention Name(s)
surgery, local tetracycline, systemic metronidazole and amoxicillin
Intervention Description
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 Outcome Measure Information:
Title
Clinical Attachment Level Gain
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Probing pocket depth reduction
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J Max Goodson, DDS, PhD
Organizational Affiliation
The Forsyth Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anne D Haffajee, BDS
Organizational Affiliation
The Forsyth Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Forsyth Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Control of Periodontal Infections

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