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Sodium Alendronate in Non Surgical Periodontal Therapy (SANSPET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 2, 2015
First Posted Date  ICMJE June 12, 2015
Last Update Posted Date June 12, 2015
Study Start Date  ICMJE November 2012
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2015)
  • Changes in pocket depth [ Time Frame: baseline and 3- and to 6-month evaluations ]
    Reductions in pocket depth overtime
  • Changes in clinical attachment level [ Time Frame: baseline and 3- and to 6-month evaluations ]
    Gain in clinical attachment level overtime
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2015)
Changes in bone defects [ Time Frame: Baseline and 6 months ]
Reduction in bone defects by bone filling
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sodium Alendronate in Non Surgical Periodontal Therapy
Official Title  ICMJE Effects of 1% Sodium Alendronate in Non Surgical Periodontal Therapy on Clinical and Tomographical Parameters: a Randomized Placebo Controlled 6-month Clinical Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Periodontitis
  • Bone Resorption
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Sodium Alendronate
    Adjunctive use of 1% sodium alendronate gel as part of periodontitis treatment
    Intervention: Drug: Sodium alendronate
  • Placebo Comparator: Placebo
    Adjunctive use of placebo gel as part of periodontitis treatment
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 9, 2015)
32
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02470611
Other Study ID Numbers  ICMJE CAAE- 22493714.5.0000.5149
22493714.5.0000.5149 ( Other Identifier: Ethics committee )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bernardo de Carvalho Dutra, Federal University of Minas Gerais
Study Sponsor  ICMJE Federal University of Minas Gerais
Collaborators  ICMJE Pontifícia Universidade Católica de Minas Gerais
Investigators  ICMJE
Study Chair: Fernando O Costa, PhD Head of Periodontology
PRS Account Federal University of Minas Gerais
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP