1% Alendronate Gel in Treatment of Chronic Periodontitis Among Smokers

Study Overview
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Brief Summary
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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
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Clinical Efficacy of Subgingivally Delivered 1% Alendronate in the Treatment of Smokers With Chronic Periodontitis: a Randomized Placebo Controlled Clinical Trial.

Conditions
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Chronic Periodontitis

Intervention / Treatment
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* Drug: Alendronate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alendronate<br>1% Alendronate gel once in periodontal pocket (Gums) | Drug: Alendronate<br> <br> |
| Placebo Comparator: Placebo<br>Placebo gel once in periodontal pocket (Gums) | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | At baseline, 2nd month and 6th month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | At baseline and 6th month |