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Sodium Alendronate in Non Surgical Periodontal Therapy (SANSPET)

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ClinicalTrials.gov Identifier: NCT02470611
Recruitment Status : Completed
First Posted : June 12, 2015
Last Update Posted : June 12, 2015
Sponsor:
Collaborator:
Pontifícia Universidade Católica de Minas Gerais
Information provided by (Responsible Party):
Bernardo de Carvalho Dutra, Federal University of Minas Gerais

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.

Condition or disease Intervention/treatment Phase
Periodontitis Bone Resorption Drug: Sodium alendronate Other: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : November 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2014

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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 Name: 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




Primary Outcome Measures :
  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 Outcome Measures :
  1. Changes in bone defects [ Time Frame: Baseline and 6 months ]
    Reduction in bone defects by bone filling



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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02470611


Locations
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Brazil
Dental clinic of pontifical catholic university
Belo Horizonte, Minas Gerais, Brazil
Sponsors and Collaborators
Federal University of Minas Gerais
Pontifícia Universidade Católica de Minas Gerais
Investigators
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Study Chair: Fernando O Costa, PhD Head of Periodontology

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Responsible Party: Bernardo de Carvalho Dutra, 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, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT02470611     History of Changes
Other Study ID Numbers: CAAE- 22493714.5.0000.5149
22493714.5.0000.5149 ( Other Identifier: Ethics committee )
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: June 12, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Bone Resorption
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Bone Diseases
Musculoskeletal Diseases
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs