At a glance
ClinicalIndex Comparison Record- ✓At least 20 teeth present
- ✓At least 5% of sites (approximately 8 sites) with pocket depth >4 mm and/or 5% sites with attachment level >4 mm
- ✓Mean attachment level <4.5 mm and mean pocket depth <3.9 mm (excluding tooth brush abrasions)
- ✕>50% of sites with pocket depth or attachment level >4 mm (advanced periodontal disease)
- ✕Pregnancy or nursing
- ✕Periodontal or antibiotic therapy in the previous 6 months
- ✕Systemic conditions that might influence periodontal disease course or treatment (e.g., diabetes, AIDS)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effect of Three Periodontal Therapies in Current Smokers and Non-Smokers
In Brief
A Phase 2 clinical trial evaluating Scaling and root planing, Metronidazole, and 2 other interventions for Periodontitis and Periodontal Diseases. Completed, enrolled 146 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Scaling and root planning (SRP) is the mechanical debridement of the tooth and root surfaces and is standard of care in periodontal therapy.
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.
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.