Sodium Alendronate in Non Surgical Periodontal Therapy (SANSPET)
Primary Purpose
Periodontitis, Bone Resorption
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Sodium alendronate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis
Eligibility 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
Sites / Locations
- Dental clinic of pontifical catholic university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Sodium Alendronate
Placebo
Arm Description
Adjunctive use of 1% sodium alendronate gel as part of periodontitis treatment
Adjunctive use of placebo gel as part of periodontitis treatment
Outcomes
Primary Outcome Measures
Changes in pocket depth
Reductions in pocket depth overtime
Changes in clinical attachment level
Gain in clinical attachment level overtime
Secondary Outcome Measures
Changes in bone defects
Reduction in bone defects by bone filling
Full Information
NCT ID
NCT02470611
First Posted
June 2, 2015
Last Updated
June 9, 2015
Sponsor
Federal University of Minas Gerais
Collaborators
Pontifícia Universidade Católica de Minas Gerais
1. Study Identification
Unique Protocol Identification Number
NCT02470611
Brief Title
Sodium Alendronate in Non Surgical Periodontal Therapy
Acronym
SANSPET
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 Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais
Collaborators
Pontifícia Universidade Católica de Minas Gerais
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Bone Resorption
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sodium Alendronate
Arm Type
Experimental
Arm Description
Adjunctive use of 1% sodium alendronate gel as part of periodontitis treatment
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Adjunctive use of placebo gel as part of periodontitis treatment
Intervention Type
Drug
Intervention Name(s)
Sodium alendronate
Other Intervention Name(s)
biphosphonates
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
Changes in pocket depth
Description
Reductions in pocket depth overtime
Time Frame
baseline and 3- and to 6-month evaluations
Title
Changes in clinical attachment level
Description
Gain in clinical attachment level overtime
Time Frame
baseline and 3- and to 6-month evaluations
Secondary Outcome Measure Information:
Title
Changes in bone defects
Description
Reduction in bone defects by bone filling
Time Frame
Baseline and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando O Costa, PhD
Organizational Affiliation
Head of Periodontology
Official's Role
Study Chair
Facility Information:
Facility Name
Dental clinic of pontifical catholic university
City
Belo Horizonte
State/Province
Minas Gerais
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Sodium Alendronate in Non Surgical Periodontal Therapy
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