1% Alendronate Gel in Treatment of Chronic Periodontitis Among Smokers

June 18, 2014 updated by: Dr. Anuj Sharma, Government Dental College and Research Institute, Bangalore

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

  • 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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline plaque scores at 2 month and 6 month
Time Frame: At baseline, 2nd month and 6th 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
Time Frame: At baseline, 2nd month and 6th 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
Time Frame: At baseline, 2nd month and 6th 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
Time Frame: At baseline, 2nd month and 6th 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
Time Frame: At baseline and 6th month
intrabony defect depth assessed at baseline and 6 months for Alendronate and placebo group
At baseline and 6th month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Government Dental College and Research Institute, Bangalore

Investigators

  • Principal Investigator: Dr. Anuj Sharma, BDS, MDS, RIMS, Ranchi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

June 11, 2014

First Submitted That Met QC Criteria

June 18, 2014

First Posted (Estimate)

June 20, 2014

Study Record Updates

Last Update Posted (Estimate)

June 20, 2014

Last Update Submitted That Met QC Criteria

June 18, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GDCRI-09-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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