Sodium Alendronate in Non Surgical Periodontal Therapy

Periodontitis Clinical Trial

— SANSPET  

Official title:

Effects of 1% Sodium Alendronate in Non Surgical Periodontal Therapy on Clinical and Tomographical Parameters: a Randomized Placebo Controlled 6-month Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02470611
• Other study ID #: CAAE- 22493714.5.0000.5149
• Secondary ID: 22493714.5.0000.
• Status: Completed
• Phase: Phase 4
• First received: June 2, 2015
• Last updated: June 9, 2015
• Start date: November 2012
• Est. completion date: November 2014

Study information

• Verified date: June 2015
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Resorption
• Periodontitis

Intervention

Drug:
• Sodium alendronate
After manual quadrant-wise scaling and root planing, at the final treatment appointment the randomized selected periodontal site (showing pocket depth = 5mm, clinical attachment loss > 3mm and proximal bone defects) received 1% sodium alendronate gel

Other:
• Placebo
After manual quadrant-wise scaling and root planing, at the final treatment appointment the randomized selected periodontal site (showing pocket depth = 5mm, clinical attachment loss > 3mm and proximal bone defects) received 1% placebo gel

Locations

Country	Name	City	State
Brazil	Dental clinic of pontifical catholic university	Belo Horizonte	Minas Gerais

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of Minas Gerais	Pontifícia Universidade Católica de Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in pocket depth	Reductions in pocket depth overtime	baseline and 3- and to 6-month evaluations	No
Primary	Changes in clinical attachment level	Gain in clinical attachment level overtime	baseline and 3- and to 6-month evaluations	No
Secondary	Changes in bone defects	Reduction in bone defects by bone filling	Baseline and 6 months	No