Effect of Three Periodontal Therapies in Current Smokers and Non-Smokers
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|ClinicalTrials.gov Identifier: NCT00066066|
Recruitment Status : Completed
First Posted : August 5, 2003
Results First Posted : April 22, 2013
Last Update Posted : April 22, 2013
|Condition or disease||Intervention/treatment||Phase|
|Periodontitis Periodontal Diseases||Procedure: Scaling and root planing Drug: Metronidazole Drug: Amoxicillin Drug: Doxycycline||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||146 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Three Periodontal Therapies in Current Smokers and Non-Smokers|
|Study Start Date :||July 2003|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2009|
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.
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.
Active Comparator: SRP + Metronidazole
Full mouth Scaling and Root Planing plus Metronidazole (MET) 250 mg tid x 14 days
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.
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
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 Name: Atridox
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00066066
|United States, Massachusetts|
|Department of Periodontology|
|Cambridge, Massachusetts, United States, 02142|
|Principal Investigator:||Anne Haffajee, DDS||Boston, MA|
|Principal Investigator:||Ricardo Teles, DDS, DMSc||The Forsyth Institute|