1% Alendronate Gel in Treatment of Chronic Periodontitis Among Smokers
Information source: Government Dental College and Research Institute, Bangalore
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Periodontitis
Intervention: Alendronate (Drug); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Government Dental College and Research Institute, Bangalore Official(s) and/or principal investigator(s): Dr. Anuj Sharma, BDS, MDS, Principal Investigator, Affiliation: RIMS, Ranchi
Summary
- Locally delivered Alendronate (ALN) have potent inhibitory effect on bone and increases
new bone formation in chronic periodontitis patients
- Till date no study has reported the effect of local delivery of ALN in chronic
periodontitis patients among smokers. Hence the aim of this study is to investigate the
clinical and radiographic effects of locally delivered ALN as an adjunct to the non
surgical treatment in smoker chronic periodontitis patients.
Clinical Details
Official title: Clinical Efficacy of Subgingivally Delivered 1% Alendronate in the Treatment of Smokers With Chronic Periodontitis: a Randomized Placebo Controlled Clinical Trial.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change from baseline plaque scores at 2 month and 6 monthChange from baseline gingival scores at 2 month and 6 month
Secondary outcome: Change from baseline Probing depth at 2 month and 6 monthChange from baseline Periodontal attachment level at 2 month and 6 month Change from baseline intrabony defect depth at 6 month
Eligibility
Minimum age: 30 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Systemically healthy subjects with probing depth (PD) ≥ 5 mm or periodontal
attachment level (PAL) ≥ 4 to 6 mm and a radiographical vertical bone loss ≥ 3 mm
- No history of periodontal therapy in preceding last 6 months
- No use of antibiotics in the preceding 6 months
Exclusion Criteria:
- Subjects with known systemic disease
- Known or suspected allergy to the ALN/bisphosphonate group
- Those on systemic ALN/bisphosphonate therapy
- Subjects with aggressive periodontitis,
- Use of smokeless tobacco in any form,
- Alcoholics
- Immunocompromised subjects
- Pregnant or lactating females
Locations and Contacts
Additional Information
Starting date: March 2009
Last updated: June 18, 2014
|