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Completed

NCT Number: NCT02470611

Sodium Alendronate in Non Surgical Periodontal Therapy

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.

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Key information

Conditions

Periodontitis Bone Diseases Bone Resorption Mouth Diseases Musculoskeletal Diseases Periodontal Diseases Stomatognathic Diseases

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dental clinic of pontifical catholic university

Belo Horizonte, Minas Gerais, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: biphosphonates

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

Primary outcomes

  1. Changes in pocket depth

    Time frame: baseline and 3- and to 6-month evaluations

    Reductions in pocket depth overtime

  2. Changes in clinical attachment level

    Time frame: baseline and 3- and to 6-month evaluations

    Gain in clinical attachment level overtime

Secondary outcomes

  1. Changes in bone defects

    Time frame: Baseline and 6 months

    Reduction in bone defects by bone filling

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Collaborators

  • Pontifícia Universidade Católica de Minas Gerais

Registry information

Official study title

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

Acronym: SANSPET

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Jun 12, 2015
Registry last updated
Jun 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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