Sodium Alendronate in Non Surgical Periodontal Therapy (SANSPET)

June 9, 2015 updated by: Bernardo de Carvalho Dutra, Federal University of Minas Gerais

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Sodium Alendronate
Adjunctive use of 1% sodium alendronate gel as part of periodontitis treatment
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 Names:
  • biphosphonates
PLACEBO_COMPARATOR: Placebo
Adjunctive use of placebo gel as part of periodontitis treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in pocket depth
Time Frame: baseline and 3- and to 6-month evaluations
Reductions in pocket depth overtime
baseline and 3- and to 6-month evaluations
Changes in clinical attachment level
Time Frame: baseline and 3- and to 6-month evaluations
Gain in clinical attachment level overtime
baseline and 3- and to 6-month evaluations

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in bone defects
Time Frame: Baseline and 6 months
Reduction in bone defects by bone filling
Baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Minas Gerais

Collaborators

Pontifícia Universidade Católica de Minas Gerais

Investigators

  • Study Chair: Fernando O Costa, PhD, Head of Periodontology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (ACTUAL)

November 1, 2013

Study Completion (ACTUAL)

November 1, 2014

Study Registration Dates

First Submitted

June 2, 2015

First Submitted That Met QC Criteria

June 9, 2015

First Posted (ESTIMATE)

June 12, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

June 12, 2015

Last Update Submitted That Met QC Criteria

June 9, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE- 22493714.5.0000.5149
  • 22493714.5.0000.5149 (OTHER: Ethics committee)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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