Control of Periodontal Infections

This study has been completed.
Sponsor:
Collaborators:
University of Goteberg, Sweden
Boston University
Information provided by:
The Forsyth Institute
ClinicalTrials.gov Identifier:
NCT01098448
First received: April 1, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Periodontitis
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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Control of Periodontal Infections

Resource links provided by NLM:


Further study details as provided by The Forsyth Institute:

Primary Outcome Measures:
  • Clinical Attachment Level Gain [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Probing pocket depth reduction [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 187
Study Start Date: September 1999
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Scaling and root planing
scaling and root planing as a solo therapy
Other: scaling and root planing
scaling and root planing as a single therapy
Experimental: Periodontal surgery Other: surgery
periodontal surgery in residual pockets of >4mm
Experimental: systemic antibiotics Drug: systemic metronidazole and amoxicillin
systemic metronidazole (250 mg tid x 14) and amoxicillin (500 mg bid x 14
Experimental: Local delivery of tetracycline Drug: local tetracycline
local delivery of tetracycline fibers releasing approximately 1.7 mg/tooth in all pockets >5mm
Experimental: local antibiotic and systemic antibiotics Drug: local antibiotics and systemic metronidazole and amoxicillin
1.7 mg/tooth tetracycline fiber plus metronidazole (250 mg tid x14d)and amoxicillin (500 mg bid x 14d)
Experimental: local antibiotics and surgery Other: local tetracycline and periodontal surgery
local delivery of tetracycline fibers releasing approximately 1.7 mg/tooth in all pockets >5mm and periodontal surgery in residual pockets of >4mm
Experimental: systemic antibiotics and surgery Other: periodontal surgery and systemic metronidazole and amoxicillin
surgery in residual pockets >4mm and metronidazole (250mg tidx14d) and amoxicillin (500mg bidx14d)
Experimental: local and systemic antibiotics and surgery Other: surgery, local tetracycline, systemic metronidazole and amoxicillin
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)

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01098448

Locations
United States, Massachusetts
The Forsyth Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
The Forsyth Institute
University of Goteberg, Sweden
Boston University
Investigators
Principal Investigator: J Max Goodson, DDS, PhD The Forsyth Institute
Principal Investigator: Anne D Haffajee, BDS The Forsyth Institute
  More Information

No publications provided

Responsible Party: Sigmund Socransky, The Forsyth Institute
ClinicalTrials.gov Identifier: NCT01098448     History of Changes
Other Study ID Numbers: NIDCR-012861
Study First Received: April 1, 2010
Last Updated: April 1, 2010
Health Authority: United States: Institutional Review Board
Sweden: Institutional Review Board

Keywords provided by The Forsyth Institute:
Amoxicillin
antibiotics
chronic periodontitis
local drug delivery
metronidazol
randomized controlled trial
subgingival scaling
surgery
tetracycline
moderate to advanced chronic periodontitis

Additional relevant MeSH terms:
Periodontitis
Mouth Diseases
Periodontal Diseases
Stomatognathic Diseases
Amoxicillin
Anti-Bacterial Agents
Antibiotics, Antitubercular
Metronidazole
Tetracycline
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014