Sodium Alendronate in Non Surgical Periodontal Therapy

Phase 4

Completed

• Conditions: Periodontitis; Bone Resorption
• Interventions: Drug: Sodium alendronate; Other: Placebo

• Registration Number: NCT02470611
• Lead Sponsor: Federal University of Minas Gerais

Brief Summary

In the past few years, studies have evaluated the effect of systemic use of sodium alendronate, especially in the treatment of structural bone defects caused by periodontal diseases. This study evaluated the effects of non-surgical periodontal treatment associated with the topical application of 1% sodium alendronate on clinical and topographical parameters. Chronic periodontitis patients were recruited for the present study and were monitored at 3 and 6 months after baseline examinations. A placebo gel was used as control.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Primary Completion: 2013-11
• Study Completion: 2014-11
• Status Verified: 2015-06
• Study First Submitted: 2015-06-02
• Study First Submitted QC: 2015-06-09
• Last Update Submitted: 2015-06-09
• Study First Posted: 2015-06-12
• Last Update Posted: 2015-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• chronic periodontitis
• two contralateral teeth showing periodontal pocket depth ≥ 5mm, clinical attachment loss > 3mm, proximal vertical bone defects, no prosthetic device, without caries lesions, proximal dental contact and lack of premature occlusal contact
• systemically healthy volunteers

Exclusion Criteria

• need for antibiotic or systemic/local antibiotic use in the previous 3 months
• periodontal treatment in the previous 6 months
• pregnancy or lactation
• immunological disorders or imune suppressive treatments
• diabetes
• smoking
• orthodontic appliances or removable prosthesis
• osteoporosis
• known or suspected allergy to biphosphonates
• systemic use of biphosphonates

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium Alendronate	Sodium alendronate	Adjunctive use of 1% sodium alendronate gel as part of periodontitis treatment
Placebo	Placebo	Adjunctive use of placebo gel as part of periodontitis treatment

Primary Outcome Measures

Name	Time	Method
Changes in pocket depth	baseline and 3- and to 6-month evaluations	Reductions in pocket depth overtime
Changes in clinical attachment level	baseline and 3- and to 6-month evaluations	Gain in clinical attachment level overtime

Secondary Outcome Measures

Name	Time	Method
Changes in bone defects	Baseline and 6 months	Reduction in bone defects by bone filling

Trial Locations

Locations (1)

Dental clinic of pontifical catholic university; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil