Sodium Alendronate in Non Surgical Periodontal Therapy (SANSPET)

Federal University of Minas Gerais

Status and phase: Completed; Phase 4

Conditions: Periodontitis; Bone Resorption

Treatments: Other: Placebo; Drug: Sodium alendronate

Study type: Interventional

Funder types: Other

Identifiers

NCT02470611

CAAE- 22493714.5.0000.5149

22493714.5.0000.5149 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups, including a placebo group

Sodium Alendronate

Experimental group

Description:

Adjunctive use of 1% sodium alendronate gel as part of periodontitis treatment

Treatment:

Drug: Sodium alendronate

Placebo

Placebo Comparator group

Description:

Adjunctive use of placebo gel as part of periodontitis treatment

Treatment:

Other: Placebo