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Control of Periodontal Infections

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01098448
First Posted: April 2, 2010
Last Update Posted: April 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Göteborg University
Boston University
Information provided by:
The Forsyth Institute
  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
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Control of Periodontal Infections

Further study details as provided by The Forsyth Institute:

Primary Outcome Measures:
  • Clinical Attachment Level Gain [ Time Frame: 24 months ]

Secondary Outcome Measures:
  • Probing pocket depth reduction [ Time Frame: 24 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01098448


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

Responsible Party: Sigmund Socransky, The Forsyth Institute
ClinicalTrials.gov Identifier: NCT01098448     History of Changes
Other Study ID Numbers: NIDCR-012861
First Submitted: April 1, 2010
First Posted: April 2, 2010
Last Update Posted: April 2, 2010
Last Verified: April 2010

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
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Bacterial Agents
Amoxicillin
Tetracycline
Antibiotics, Antitubercular
Metronidazole
Anti-Infective Agents
Antitubercular Agents
Antiprotozoal Agents
Antiparasitic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action