- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00066066
Effect of Three Periodontal Therapies in Current Smokers and Non-Smokers
March 6, 2013 updated by: The Forsyth Institute
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
146
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Cambridge, Massachusetts, United States, 02142
- Department of Periodontology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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Scaling and root planning (SRP) is the mechanical debridement of the tooth and root surfaces and is standard of care in periodontal therapy.
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Active Comparator: SRP + Metronidazole
Full mouth Scaling and Root Planing plus Metronidazole (MET) 250 mg tid x 14 days
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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.
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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
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Amoxicillin (AMOX) is a broad spectrum antibiotic and was prescribed at 500 mg tid for 14d.
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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Baseline, 3, 6 and 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anne Haffajee, DDS, Boston, MA
- Principal Investigator: Ricardo Teles, DDS, DMSc, The Forsyth Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2003
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
August 1, 2003
First Submitted That Met QC Criteria
August 4, 2003
First Posted (Estimate)
August 5, 2003
Study Record Updates
Last Update Posted (Estimate)
April 22, 2013
Last Update Submitted That Met QC Criteria
March 6, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIDCR-14242
- R01DE014242 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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