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Effect of Three Periodontal Therapies in Current Smokers and Non-Smokers
This study is currently recruiting participants.
Study NCT00066066   Information provided by National Institute of Dental and Craniofacial Research (NIDCR)
First Received: August 1, 2003   Last Updated: July 15, 2008   History of Changes

August 1, 2003
July 15, 2008
July 2003
April 2008   (final data collection date for primary outcome measure)
Change in mean attachment level [ Time Frame: Baseline, 3, 6 12 18 and 24 months ] [ Designated as safety issue: No ]
  • Periodontal attachment level
  • Periodontal pocket depth
  • Counts of 40 bacterial subgingival species
Complete list of historical versions of study NCT00066066 on ClinicalTrials.gov Archive Site
 
 
 
Effect of Three Periodontal Therapies in Current Smokers and Non-Smokers
Effect of Three Periodontal Therapies in Current Smokers and Non-Smokers

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.

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.

Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
  • Periodontitis
  • Periodontal Diseases
  • Drug: Group 1: metronidazole
  • Drug: Group 2: metronidazole + amoxicillin + locally delivered
  • Drug: Tetracycline
  • Drug: Metronidazole
  • 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.
  • Placebo Comparator: Amoxicillin
  • Placebo Comparator: Tetracycline
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
216
April 2009
April 2008   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
 
United States
 
NCT00066066
Anne D. Haffajee/PI/Chair Department of Periodontology/Senior Member of the Staff, The Forsyth Institute
NIDCR-14242
National Institute of Dental and Craniofacial Research (NIDCR)
 
Principal Investigator: Anne Haffajee, DDS Boston, MA
National Institute of Dental and Craniofacial Research (NIDCR)
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP