1% Alendronate Gel in Treatment of Chronic Periodontitis Among Smokers

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

- 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.

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 month

Change from baseline gingival scores at 2 month and 6 month

Secondary outcome:

Change from baseline Probing depth at 2 month and 6 month

Change from baseline Periodontal attachment level at 2 month and 6 month

Change from baseline intrabony defect depth at 6 month

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

Starting date: March 2009
Last updated: June 18, 2014