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

The Forsyth Institute

Status and phase: Completed; Phase 2

Conditions: Periodontitis; Periodontal Diseases

Treatments: Drug: Amoxicillin; Procedure: Scaling and root planing; Drug: Doxycycline; Drug: Metronidazole

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00066066

R01DE014242 (U.S. NIH Grant/Contract)

NIDCR-14242

Details and patient eligibility

About

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.

Full 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.

Enrollment: 146 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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146 participants in 3 patient groups, including a placebo group

Scaling and root planing alone

Placebo Comparator group

Description:

Full mouth scaling and root planing (SRP) alone plus a placebo pill taken twice daily for 2 weeks.

Treatment:

Procedure: Scaling and root planing

SRP + Metronidazole

Active Comparator group

Description:

Full mouth Scaling and Root Planing plus Metronidazole (MET) 250 mg tid x 14 days

Treatment:

Drug: Metronidazole

SRP + MET + Amoxicillin + Doxycycline

Active Comparator group

Description:

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

Treatment:

Drug: Doxycycline

Drug: Amoxicillin