Sodium Alendronate in Non Surgical Periodontal Therapy

Condition(s) targeted: Periodontitis; Bone Resorption

Intervention: Sodium alendronate (Drug); Placebo (Other)

Phase: Phase 4

Status: Completed

Sponsored by: Federal University of Minas Gerais

Official(s) and/or principal investigator(s):
Fernando O Costa, PhD, Study Chair, Affiliation: Head of Periodontology

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.

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

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

Primary outcome:

Changes in pocket depth

Changes in clinical attachment level

Secondary outcome: Changes in bone defects

Minimum age: 30 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

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

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

Starting date: November 2012
Last updated: June 9, 2015