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

PHASE2CompletedINTERVENTIONAL
Enrollment

146

Participants

Timeline

Start Date

July 31, 2003

Primary Completion Date

July 31, 2009

Study Completion Date

July 31, 2009

Conditions
PeriodontitisPeriodontal Diseases
Interventions
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.

Trial Locations (1)

02142

Department of Periodontology, Cambridge

All Listed Sponsors
collaborator

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

lead

The Forsyth Institute

OTHER

NCT00066066 - Effect of Three Periodontal Therapies in Current Smokers and Non-Smokers | Biotech Hunter | Biotech Hunter