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Sponsored by: |
National Institute of Dental and Craniofacial Research (NIDCR) |
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Information provided by: | National Institute of Dental and Craniofacial Research (NIDCR) |
ClinicalTrials.gov Identifier: | NCT00066066 |
The purpose of this study is to determine in current and non-smokers the clinical and microbiological effects of 3 therapies: scaling and root planing (SRP) alone; SRP in combination with the orally administered antibiotic metronidazole; and SRP with the orally administered antibiotics metronidazole and amoxicillin along with the locally delivered antibiotic doxycycline at periodontal pockets >= 4 mm.
Condition | Intervention | Phase |
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Periodontitis Periodontal Diseases |
Drug: Group 1: metronidazole Drug: Group 2: metronidazole + amoxicillin + locally delivered Drug: Tetracycline Drug: Metronidazole |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Effect of Three Periodontal Therapies in Current Smokers and Non-Smokers |
Estimated Enrollment: | 216 |
Study Start Date: | July 2003 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A1: Placebo Comparator
The arms of the study are based on 3 treatment groups 1. scaling and root planing alone (SRP); 2. SRP + systemically administered metronidazole; 3. SRP + systemically administered metronidazole and amoxicillin and locally delivered tetracycline; in both smokers and non smokers with chronic periodontitis. |
Drug: Group 1: metronidazole
antibiotic that is particularly effective against gram negative bacterial species.
Drug: Group 2: metronidazole + amoxicillin + locally delivered
Amoxicillin is a broad spectrum antibiotic that is effective against a wide range of bacterial species.
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A2: Placebo Comparator
Amoxicillin
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Drug: Metronidazole
Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species.
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A3: Placebo Comparator
Tetracycline
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Drug: Tetracycline
Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally.
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Cigarette smokers have more severe periodontal disease and more widespread colonization by periodontal pathogens than non smokers. In addition, smokers respond less well to periodontal therapies, particularly mechanical therapies such as scaling and root planing (SRP) and surgery. Recent data from our laboratory have indicated that treatment that included antibiotics produced a better clinical effect in smokers than mechanical therapy alone. Thus, the purpose of the present investigation is to compare the immediate and long-term effects of 3 periodontal therapies on clinical, microbiological and host parameters in current and non smokers. In this double blind, placebo-controlled, randomized study, 108 current smokers and 108 non smokers will be randomly assigned to 1 of 3 treatment groups: SRP alone; SRP + systemically administered metronidazole; SRP + systemically administered amoxicillin and metronidazole and local delivery of doxycycline at pockets > 4 mm. Plaque Index, Gingival Index, % of sites with bleeding on probing, suppuration, pocket depth and attachment level will be measured at 6 sites per tooth at all teeth excluding 3rd molars at baseline, 3, 6, 12, 18 and 24 months.
Subgingival plaque samples taken from the mesial aspect of each tooth at the same time points will be analyzed individually for their content of 40 subgingival species using checkerboard DNA-DNA hybridization. Antibody levels to 20 subgingival species will be measured in serum samples taken at baseline, 6 and 24 months. Levels of IL-1b, IL-10 and IFNg will be measured in GCF samples taken from the 4 deepest pockets at baseline, 3, 6 and 24 months. The major hypothesis to be tested is whether smokers respond better to periodontal therapies that include 1 or more antibiotics. Other hypotheses will test whether host and microbiological parameters differ between smokers and non smokers and if such parameters are comparably altered after therapy in both groups. The results will be of immediate clinical benefit to the large segment of periodontal patients who smoke cigarettes.
Smokers make up 26 - 30% of the adult population and form a disproportionately high segment of the population requiring periodontal treatment. They may have special needs in terms of periodontal therapy which should be clarified by the proposed investigation. In addition, the cigarette smoker is an example of a periodontal patient who is "compromised" in terms of his/her ability to cope with infectious diseases. The proposed investigation should provide a model to examine methods that could be useful in treating compromised patients whether compromised by harmful habits such as smoking, systemic disease or genetic background.
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Department of Periodontology | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Anne Haffajee, DDS 617-262-5200 ext 243 ahaffajee@forsyth.org | |
Principal Investigator: Anne Haffajee |
Principal Investigator: | Anne Haffajee, DDS | Boston, MA |
Responsible Party: | The Forsyth Institute ( Anne D. Haffajee/PI/Chair Department of Periodontology/Senior Member of the Staff ) |
Study ID Numbers: | NIDCR-14242 |
Study First Received: | August 1, 2003 |
Last Updated: | July 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00066066 History of Changes |
Health Authority: | United States: Federal Government |
Mouth Diseases Metronidazole Anti-Bacterial Agents Amoxicillin Periodontal Diseases |
Radiation-Sensitizing Agents Periodontitis Stomatognathic Diseases Tetracycline |
Mouth Diseases Metronidazole Anti-Infective Agents Antiprotozoal Agents Amoxicillin Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Enzyme Inhibitors Tetracycline |
Pharmacologic Actions Protein Synthesis Inhibitors Anti-Bacterial Agents Antiparasitic Agents Periodontal Diseases Radiation-Sensitizing Agents Periodontitis Therapeutic Uses Stomatognathic Diseases |