Control of Periodontal Infections
1 other identifier
interventional
187
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 1999
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
April 1, 2010
CompletedFirst Posted
Study publicly available on registry
April 2, 2010
CompletedApril 2, 2010
April 1, 2010
5.3 years
April 1, 2010
April 1, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical Attachment Level Gain
24 months
Secondary Outcomes (1)
Probing pocket depth reduction
24 months
Study Arms (8)
Scaling and root planing
ACTIVE COMPARATORscaling and root planing as a solo therapy
Periodontal surgery
EXPERIMENTALsystemic antibiotics
EXPERIMENTALLocal delivery of tetracycline
EXPERIMENTALlocal antibiotic and systemic antibiotics
EXPERIMENTALlocal antibiotics and surgery
EXPERIMENTALsystemic antibiotics and surgery
EXPERIMENTALlocal and systemic antibiotics and surgery
EXPERIMENTALInterventions
local delivery of tetracycline fibers releasing approximately 1.7 mg/tooth in all pockets \>5mm
systemic metronidazole (250 mg tid x 14) and amoxicillin (500 mg bid x 14
1.7 mg/tooth tetracycline fiber plus metronidazole (250 mg tid x14d)and amoxicillin (500 mg bid x 14d)
local delivery of tetracycline fibers releasing approximately 1.7 mg/tooth in all pockets \>5mm and periodontal surgery in residual pockets of \>4mm
surgery in residual pockets \>4mm and metronidazole (250mg tidx14d) and amoxicillin (500mg bidx14d)
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Forsyth Institutelead
- Göteborg Universitycollaborator
- Boston Universitycollaborator
Study Sites (1)
The Forsyth Institute
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
J Max Goodson, DDS, PhD
The Forsyth Institute
- PRINCIPAL INVESTIGATOR
Anne D Haffajee, BDS
The Forsyth Institute
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 1, 2010
First Posted
April 2, 2010
Study Start
September 1, 1999
Primary Completion
December 1, 2004
Study Completion
December 1, 2004
Last Updated
April 2, 2010
Record last verified: 2010-04