Control of Periodontal Infections
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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 |
- Clinical Attachment Level Gain [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- 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 |
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| United States, Massachusetts | |
| The Forsyth Institute | |
| Boston, Massachusetts, United States, 02115 | |
| 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 Periodontal Diseases Mouth Diseases Stomatognathic Diseases Tetracycline Amoxicillin Anti-Bacterial Agents Metronidazole Protein Synthesis Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Infective Agents Therapeutic Uses Radiation-Sensitizing Agents Physiological Effects of Drugs Antiprotozoal Agents Antiparasitic Agents |
ClinicalTrials.gov processed this record on May 19, 2013