1% Alendronate Gel in Treatment of Chronic Periodontitis Among Smokers

Phase 2

Completed

• Conditions: Chronic Periodontitis
• Interventions: Drug: Placebo; Drug: Alendronate

• Registration Number: NCT02168543
• Lead Sponsor: Government Dental College and Research Institute, Bangalore

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2011-01
• Study Completion: 2011-04
• Status Verified: 2014-06
• Study First Submitted: 2014-06-11
• Study First Submitted QC: 2014-06-18
• Last Update Submitted: 2014-06-18
• Study First Posted: 2014-06-20
• Last Update Posted: 2014-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo gel once in periodontal pocket (Gums)
Alendronate	Alendronate	1% Alendronate gel once in periodontal pocket (Gums)

Primary Outcome Measures

Name	Time	Method
Change from baseline plaque scores at 2 month and 6 month	At baseline, 2nd month and 6th month	Plaque scores assessed at baseline, at 2 months and 6 months for Alendronate and placebo group
Change from baseline gingival scores at 2 month and 6 month	At baseline, 2nd month and 6th month	Gingival scores assessed at baseline, at 2 months and 6 months for Alendronate and placebo group

Secondary Outcome Measures

Name	Time	Method
Change from baseline Probing depth at 2 month and 6 month	At baseline, 2nd month and 6th month	Probing depth assessed at baseline, at 2 months and 6 months for Alendronate and placebo group
Change from baseline Periodontal attachment level at 2 month and 6 month	At baseline, 2nd month and 6th month	Periodontal attachment level assessed at baseline, at 2 months and 6 months for Alendronate and placebo group
Change from baseline intrabony defect depth at 6 month	At baseline and 6th month	intrabony defect depth assessed at baseline and 6 months for Alendronate and placebo group