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Effect of Three Periodontal Therapies in Current Smokers and Non-Smokers

This study is currently recruiting patients

Verified by National Institute of Dental and Craniofacial Research (NIDCR) September 2006

Sponsored by: National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by: National Institute of Dental and Craniofacial Research (NIDCR)
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: doxycycline
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title: Effect of Three Periodontal Therapies in Current Smokers and Non-Smokers

Further study details as provided by National Institute of Dental and Craniofacial Research (NIDCR):
Primary Outcomes: Periodontal attachment level; Periodontal pocket depth; Counts of 40 bacterial subgingival species
Expected Total Enrollment:  216

Study start: July 2003;  Expected completion: December 2008
Last follow-up: April 2008;  Data entry closure: April 2008

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 above,  Genders Eligible for Study:  Both
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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00066066


Massachusetts
Department of Periodontology, Boston,  Massachusetts,  02115,  United States; Recruiting
Anne Haffajee, DDS  617-262-5200  Ext. 243    ahaffajee@forsyth.org 
Anne Haffajee,  Principal Investigator

Study chairs or principal investigators

Anne Haffajee, DDS,  Principal Investigator,  Boston, MA   

More Information

Study ID Numbers:  NIDCR-14242
Last Updated:  September 13, 2006
Record first received:  August 1, 2003
ClinicalTrials.gov Identifier:  NCT00066066
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-09-29





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