search
Back to results

1% Alendronate Gel in Treatment of Chronic Periodontitis Among Smokers

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Alendronate
Placebo
Sponsored by
Government Dental College and Research Institute, Bangalore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Alendronate

    Placebo

    Arm Description

    1% Alendronate gel once in periodontal pocket (Gums)

    Placebo gel once in periodontal pocket (Gums)

    Outcomes

    Primary Outcome Measures

    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
    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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    June 11, 2014
    Last Updated
    June 18, 2014
    Sponsor
    Government Dental College and Research Institute, Bangalore
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02168543
    Brief Title
    1% Alendronate Gel in Treatment of Chronic Periodontitis Among Smokers
    Official Title
    Clinical Efficacy of Subgingivally Delivered 1% Alendronate in the Treatment of Smokers With Chronic Periodontitis: a Randomized Placebo Controlled Clinical Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2009 (undefined)
    Primary Completion Date
    January 2011 (Actual)
    Study Completion Date
    April 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Government Dental College and Research Institute, Bangalore

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Periodontitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    46 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Alendronate
    Arm Type
    Experimental
    Arm Description
    1% Alendronate gel once in periodontal pocket (Gums)
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo gel once in periodontal pocket (Gums)
    Intervention Type
    Drug
    Intervention Name(s)
    Alendronate
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Change from baseline plaque scores at 2 month and 6 month
    Description
    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
    Title
    Change from baseline gingival scores at 2 month and 6 month
    Description
    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 Outcome Measure Information:
    Title
    Change from baseline Probing depth at 2 month and 6 month
    Description
    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
    Title
    Change from baseline Periodontal attachment level at 2 month and 6 month
    Description
    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
    Title
    Change from baseline intrabony defect depth at 6 month
    Description
    intrabony defect depth assessed at baseline and 6 months for Alendronate and placebo group
    Time Frame
    At baseline and 6th month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dr. Anuj Sharma, BDS, MDS
    Organizational Affiliation
    RIMS, Ranchi
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    1% Alendronate Gel in Treatment of Chronic Periodontitis Among Smokers

    We'll reach out to this number within 24 hrs