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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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29 June 2015 |
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Main ID: |
NCT02470611 |
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Date of registration:
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02/06/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Sodium Alendronate in Non Surgical Periodontal Therapy
SANSPET |
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Scientific title:
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Effects of 1% Sodium Alendronate in Non Surgical Periodontal Therapy on Clinical and Tomographical Parameters: a Randomized Placebo Controlled 6-month Clinical Trial |
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Date of first enrolment:
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November 2012 |
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Target sample size:
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32 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02470611 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Fernando O Costa, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Head of Periodontology |
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Key inclusion & exclusion criteria
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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
Age minimum:
30 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Periodontitis
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Bone Resorption
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Intervention(s)
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Other: Placebo
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Drug: Sodium alendronate
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Primary Outcome(s)
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Changes in clinical attachment level
[Time Frame: baseline and 3- and to 6-month evaluations]
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Changes in pocket depth
[Time Frame: baseline and 3- and to 6-month evaluations]
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Secondary Outcome(s)
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Changes in bone defects
[Time Frame: Baseline and 6 months]
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Secondary ID(s)
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CAAE- 22493714.5.0000.5149
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22493714.5.0000.5149
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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