Effect of Three Periodontal Therapies in Current Smokers and Non-Smokers
Condition: Periodontitis; Periodontal Diseases
MeSH terms: Periodontitis; Periodontal Diseases
Intervention: Scaling and root planing; Metronidazole; Amoxicillin; Doxycycline
Intervention description: 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.
Intervention MeSH terms: Amoxicillin; Metronidazole; Doxycycline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 146.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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