Immunological and clinical evaluation of supporting dental tissues using local simvastatin a controlled clinical trial

Not Applicable

Recruiting

• Conditions: Chronic periodontitis; K05.3

• Registration Number: RBR-74j2z5
• Lead Sponsor: Faculdade de Odontologia da Universidade de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-18
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Age between 30 years and 70 years. At least 15 teeth in the mouth excluding third molars. Diagnosis of generalized chronic periodontitis according to Armitage et al 1999, which provides for the collection of clinical, radiographic findings and verification of medical and dental history. As clinical periodontal findings, patients should have at least 30% of the periodontal sites with PCS and NCI > 4mm and bleeding on probing. In addition, they should have radiographic evidence of bone loss around the viable teeth. D) Go to scheduled return visits, and should be able to maintain good biofilm control at reevaluations (O'Leary plaque index <30%)

Exclusion Criteria

Patients with medical history linked to systemic diseases. Hypersensitivity to any type of statin. Have used any type of antibiotic for at least 3 months prior to the study. Had peridontal treatment 6 months before the beginning of the trial. Being pregnant and / or breastfeeding. Alcohol users, smokers and ex-smokers (5 years at least). Patients with cancer and / or undergoing chemotherapeutic / radiotherapeutic treatment. Patients diagnosed with aggressive periodontitis. Also excluded from the analyzes dental elements that have pathogenic endodontic ivolvement, third molars and dental implants

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the clinical attachment gain of periodontal pockets (sites with PD more or equal to 5 mm), calculated by the difference at the baseline periodontal evaluation and pos-treatment, as 1.4mm of standard deviation and 95% confidence interval.

Secondary Outcome Measures

Name	Time	Method
Evaluate the differences on Plaque index, pocket depth, bleeding on probing, gingival crevicular fluid cytokines, and salivary cytokines before and after treatment, as noticed 95% confidence interval.