Sodium Alendronate in Non Surgical Periodontal Therapy

NCT02470611 | Completed Phase 4

• 2 other identifiers: CAAE- 22493714.5.0000.514922493714.5.0000.5149
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis; Bone Resorption

Outcome Measures

Primary Outcomes (2)

• Changes in pocket depth

  Reductions in pocket depth overtime

  baseline and 3- and to 6-month evaluations

• Changes in clinical attachment level

  Gain in clinical attachment level overtime

  baseline and 3- and to 6-month evaluations

Secondary Outcomes (1)

• Changes in bone defects

  Baseline and 6 months

Study Arms (2)

Sodium Alendronate

EXPERIMENTAL

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

Drug: Sodium alendronate

Placebo

PLACEBO COMPARATOR

Adjunctive use of placebo gel as part of periodontitis treatment

Other: Placebo

Interventions

Sodium alendronate DRUG

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

Also known as: biphosphonates

Sodium Alendronate

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Minas Gerais: lead
• Pontifícia Universidade Católica de Minas Gerais: collaborator

Study Sites (1)

Dental clinic of pontifical catholic university

Belo Horizonte, Minas Gerais, Brazil

Location

MeSH Terms

Conditions

Periodontitis; Bone Resorption

Interventions

Alendronate; Diphosphonates

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Officials

• Fernando O Costa, PhD

  Head of Periodontology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical evaluation and treatment for the effect of image periodontal mechanical non surgical associated with application of topical alendronate sodium a 1% repair periodontal: randomized controlled clinical trial

Study Record Dates

• First Submitted: June 2, 2015
• First Posted: June 12, 2015
• Study Start: November 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2014
• Last Updated: June 12, 2015

Record last verified: 2015-06

Locations

BR (1)