Status:
COMPLETED
MTZ Plus AMX in the Treatment of Smokers and Non-smokers
Lead Sponsor:
University of Guarulhos
Conditions:
Chronic Periodontitis
Smoking
Eligibility:
All Genders
35-75 years
Phase:
PHASE4
Brief Summary
Randomized controlled clinical trials have demonstrated that the use of amoxicillin (AMX) and metronidazole (MTZ) as adjuncts to mechanical therapy improves the clinical and microbiological outcomes o...
Detailed Description
Sample size calculation: This study is designed to compare the clinical and microbiological effects of the treatment of smoker and non-smoker subjects with SRP+MTZ+AMX. The ideal sample size to assur...
Eligibility Criteria
Inclusion
- Chronic periodontitis (AAP 1999);
- ≥35 years of age;
- Presence of at least 15 teeth;
- Minimum of 6 teeth with at least one site each with PD and clinical attachment level (CAL) ≥5 mm;
- At least 30% of the sites with PD and CAL ≥4 mm and bleeding on probing (BOP).
- Smokers: had smoked at least 10 cigarettes per day for a minimum of 5 years;
- Non-smokers: had never smoked.
Exclusion
- Previous subgingival periodontal therapy;
- Pregnancy;
- Nursing;
- Systemic diseases that could affect the progression of periodontal disease (e.g. diabetes, osteoporosis);
- Long-term administration of anti - inflammatory medications;
- Need for antibiotic pre-medication for routine dental therapy;
- Continuous use of mouthrinses containing antimicrobials;
- Antibiotic therapy in the previous 6 months
- Allergy to MTZ or AMX.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT01837199
Start Date
July 1 2011
Last Update
April 23 2013
Active Locations (1)
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1
University of Guarulhos
Guarulhos, São Paulo/ SP, Brazil, 07023-070