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Effect of Three Periodontal Therapies in Current Smokers and Non-Smokers
This study has been completed.

First Received on August 1, 2003.   Last Updated on November 8, 2010   History of Changes
Sponsor: The Forsyth Institute
Collaborator: National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by: The Forsyth Institute
ClinicalTrials.gov Identifier: NCT00066066
  Purpose

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
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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Three Periodontal Therapies in Current Smokers and Non-Smokers

Resource links provided by NLM:


Further study details as provided by The Forsyth Institute:

Primary Outcome Measures:
  • Change in mean attachment level [ Time Frame: Baseline, 3, 6 12 18 and 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 216
Study Start Date: July 2003
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A1
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.
Placebo Comparator: A2
Amoxicillin
Drug: Metronidazole
Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species.
Placebo Comparator: A3
Tetracycline
Drug: Tetracycline
Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • > 20 teeth
  • > 5% sites (approx. 8 sites) with pocket depth > 4 mm and / or 5% sites with attachment level > 4 mm and mean AL < 4.5 mm and mean PD < 3.9 mm (not including tooth brush abrasions).

Exclusion Criteria:

  • > 50% of sites with pocket depth or attachment level > 4 mm
  • Pregnancy or nursing
  • Periodontal or antibiotic therapy in the previous 6 months
  • Any systemic condition which might influence the course of periodontal disease or treatment (e.g. diabetes, AIDS)
  • Any systemic condition which requires antibiotic coverage for routine periodontal procedures (e.g. heart conditions, joint replacements etc.)
  • Liver disease
  • Any known allergy to amoxicillin, metronidazole or doxycycline
  • Lactose intolerance
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00066066

Locations
United States, Massachusetts
Department of Periodontology
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
The Forsyth Institute
Investigators
Principal Investigator: Anne Haffajee, DDS Boston, MA
  More Information

No publications provided

Responsible Party: Ricardo Teles/PI/Associate Member of the Staff, The Forsyth Institute
ClinicalTrials.gov Identifier: NCT00066066     History of Changes
Other Study ID Numbers: NIDCR-14242, R01DE014242
Study First Received: August 1, 2003
Last Updated: November 8, 2010
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on February 09, 2012