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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00066066
Recruitment Status : Completed
First Posted : August 5, 2003
Results First Posted : April 22, 2013
Last Update Posted : April 22, 2013
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
The Forsyth Institute

Tracking Information
First Submitted Date  ICMJE August 1, 2003
First Posted Date  ICMJE August 5, 2003
Results First Submitted Date  ICMJE December 11, 2012
Results First Posted Date  ICMJE April 22, 2013
Last Update Posted Date April 22, 2013
Study Start Date  ICMJE July 2003
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2013)
Change in Mean Clinical Attachment Level. [ Time Frame: Baseline, 3, 6 and 12 months ]
Periodontal diseases are clinically diagnosed by assessments of gingival inflammation and measurements of tissue destruction. The damage to the apparatus of support of the teeth is quantified using measurements of probing pocket depth (PD) and clinical attachment level (CAL). These measurements are obtained using a periodontal probe which is introduced into the gingival sulcus to determine the distance in millimeters from the gingival margin to the depth of the sulcus or pocket (PD). Since the gingival margin fluctuates in response to inflammation (hyperplasia) or might recede, a more accurate measure of loss of attachment is obtained using the CAL, which measures the distance from a "fixed" landmark on the tooth such as the cemento-enamel junction to the depth of the pocket. Changes in CAL from baseline were used to assess results obtained with the treatment of periodontal diseases.
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • Periodontal attachment level
  • Periodontal pocket depth
  • Counts of 40 bacterial subgingival species
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Effect of Three Periodontal Therapies in Current Smokers and Non-Smokers
Official Title  ICMJE Effect of Three Periodontal Therapies in Current Smokers and Non-Smokers
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Periodontitis
  • Periodontal Diseases
Intervention  ICMJE
  • Procedure: Scaling and root planing
    Scaling and root planning (SRP) is the mechanical debridement of the tooth and root surfaces and is standard of care in periodontal therapy.
  • Drug: Metronidazole
    Metronidazole (MET) is an antibiotic that is particularly effective against Gram negative bacterial species. The dose for this study is: 250 mg tid x 14d.
  • Drug: Amoxicillin
    Amoxicillin (AMOX) is a broad spectrum antibiotic and was prescribed at 500 mg tid for 14d.
  • Drug: Doxycycline
    The ATRIDOX (doxycycline hyclate) ® product is a subgingival controlled-release product composed of a two syringe mixing system. Syringe A contains 450 mg of the ATRIGEL® Delivery System, which is a bioabsorbable, flowable polymeric formulation composed of 36.7% poly(DLlactide) (PLA) dissolved in 63.3% N-methyl-2-pyrrolidone (NMP). Syringe B contains 50 mg of doxycycline hyclate which is equivalent to 42.5 mg doxycycline. The constituted product is a pale yellow to yellow viscous liquid with a concentration of 10% of doxycycline hyclate. Upon contact with the crevicular fluid, the liquid product solidifies and then allows for controlled release of drug for a period of 7 days. Doxycycline is a broad-spectrum antibiotic synthetically derived from oxytetracycline.
    Other Name: Atridox
Study Arms  ICMJE
  • Placebo Comparator: Scaling and root planing alone
    Full mouth scaling and root planing (SRP) alone plus a placebo pill taken twice daily for 2 weeks.
    Intervention: Procedure: Scaling and root planing
  • Active Comparator: SRP + Metronidazole
    Full mouth Scaling and Root Planing plus Metronidazole (MET) 250 mg tid x 14 days
    Intervention: Drug: Metronidazole
  • Active Comparator: SRP + MET + Amoxicillin + Doxycycline
    Full mouth Scaling and Root Planing plus Metronidazole (MET) 250 mg tid x 14 d and Amoxicillin (AMOX) 500 mg tid for 14 days and local drug delivery of Doxycycline (TET LDD) in pockets >4mm
    • Drug: Amoxicillin
    • Drug: Doxycycline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 6, 2013)
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00066066
Other Study ID Numbers  ICMJE NIDCR-14242
R01DE014242 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The Forsyth Institute
Study Sponsor  ICMJE The Forsyth Institute
Collaborators  ICMJE National Institute of Dental and Craniofacial Research (NIDCR)
Investigators  ICMJE
Principal Investigator: Anne Haffajee, DDS Boston, MA
Principal Investigator: Ricardo Teles, DDS, DMSc The Forsyth Institute
PRS Account The Forsyth Institute
Verification Date March 2013

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