1% Alendronate Gel in Treatment of Chronic Periodontitis Among Smokers

Government Dental College and Research Institute, Bangalore46 enrolled

Overview

* 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Chronic Periodontitis

Interventions

AlendronateDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 30 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change from baseline plaque scores at 2 month and 6 month

Plaque scores assessed at baseline, at 2 months and 6 months for Alendronate and placebo group

Time frame: At baseline, 2nd month and 6th month

Change from baseline gingival scores at 2 month and 6 month

Gingival scores assessed at baseline, at 2 months and 6 months for Alendronate and placebo group

Time frame: At baseline, 2nd month and 6th month

Secondary Outcomes

Change from baseline Probing depth at 2 month and 6 month

Probing depth assessed at baseline, at 2 months and 6 months for Alendronate and placebo group

Time frame: At baseline, 2nd month and 6th month

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

Periodontal attachment level assessed at baseline, at 2 months and 6 months for Alendronate and placebo group

Time frame: At baseline, 2nd month and 6th month

Change from baseline intrabony defect depth at 6 month

intrabony defect depth assessed at baseline and 6 months for Alendronate and placebo group

Time frame: At baseline and 6th month

Data from ClinicalTrials.gov

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