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Local Host Modulating Agents Alendronate & Aloe Vera for Treatment of Furcation Defects in Chronic Periodontitis

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
placebo
Alendronate
Aloe Vera
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

25 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:Systemically healthy patients with mandibular class II furcation defects and asymptomatic endodontically vital mandibular molars with radiolucency in furcation area with PD ≥ 5mm and horizontal PD ≥ 3mm and with no history of antibiotic or any periodontal therapy in past 6 months were included in the study -

Exclusion Criteria:Subjects with any known systemic disease, allergic to alendronate or aloe vera, on systemic alendronate therapy, alcoholics, tobacco users, pregnant or lactating women

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Active Comparator

    Active Comparator

    Arm Label

    group 1

    group 2

    group 3

    Arm Description

    Scaling and root planing (SRP) followed by placebo gel local drug delivery

    SRP followed by 1% Alendronate (ALN) gel

    SRP followed by Aloevera (AV) gel

    Outcomes

    Primary Outcome Measures

    Change in Bone defect depth
    Assessed in percentage

    Secondary Outcome Measures

    Change in modified sulcus bleeding index
    scale 0-3
    Change in Plaque index
    scale 0-3
    Change in pocket probing depth
    measured in mm
    Change in relative vertical clinical attachment level
    measured in mm
    Change in relative horizontal clinical attachment level
    measured in mm

    Full Information

    First Posted
    June 28, 2017
    Last Updated
    June 28, 2017
    Sponsor
    Government Dental College and Research Institute, Bangalore
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03204097
    Brief Title
    Local Host Modulating Agents Alendronate & Aloe Vera for Treatment of Furcation Defects in Chronic Periodontitis
    Official Title
    1% Alendronate and Aloevera Gel Local Host Modulating Agents in Chronic Periodontitis Subjects With Class II Furcation Defects: A Randomized Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2016 (Actual)
    Primary Completion Date
    February 2017 (Actual)
    Study Completion Date
    February 2017 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    Alendronate (ALN), commonly use bisphosphonates is proposed to have osteostimulative properties in vivo and in vitro, as shown by an increase in the matrix formation, and acts as a potent inhibitor of bone resorption. AV widely known for its wound healing, analgesic, antioxidant, antibacterial, antiviral, antifungal, immune boosting and significant anti-inflammatory properties. The present study aims to explore the efficacy of 1% ALN and AV gel as a local drug delivery as an adjunct to scaling and root planing (SRP) for the treatment of degree II furcation defects
    Detailed Description
    Alendronate (ALN), commonly use bisphosphonates is proposed to have osteostimulative properties in vivo and in vitro, as shown by an increase in the matrix formation, and acts as a potent inhibitor of bone resorption. AV widely known for its wound healing, analgesic, antioxidant, antibacterial, antiviral, antifungal, immune boosting and significant anti-inflammatory properties. The present study aims to explore the efficacy of 1% ALN and AV gel as a local drug delivery as an adjunct to scaling and root planing (SRP) for the treatment of degree II furcation defects. Methods: Ninety patients with mandibular buccal class II furcation defects were randomly allocated into three treatment groups: SRP plus placebo gel (group 1), SRP plus 1% ALN gel (group 2) and SRP plus AV gel (group3). Clinical and radiographic parameters were recorded at baseline and gel were delivered at respective site. Then again all clinical and radiographic parameters were recorded after 6 and 12 months from baseline.

    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, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    90 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    group 1
    Arm Type
    Placebo Comparator
    Arm Description
    Scaling and root planing (SRP) followed by placebo gel local drug delivery
    Arm Title
    group 2
    Arm Type
    Active Comparator
    Arm Description
    SRP followed by 1% Alendronate (ALN) gel
    Arm Title
    group 3
    Arm Type
    Active Comparator
    Arm Description
    SRP followed by Aloevera (AV) gel
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Other Intervention Name(s)
    inactive drug
    Intervention Description
    Oral prophylaxis followed by placement of placebo gel
    Intervention Type
    Drug
    Intervention Name(s)
    Alendronate
    Other Intervention Name(s)
    ALN
    Intervention Description
    Oral prophylaxis followed by placement of Alendronate gel
    Intervention Type
    Drug
    Intervention Name(s)
    Aloe Vera
    Other Intervention Name(s)
    AV
    Intervention Description
    Oral prophylaxis followed by placement of Aloe Vera gel
    Primary Outcome Measure Information:
    Title
    Change in Bone defect depth
    Description
    Assessed in percentage
    Time Frame
    baseline, 6 & 12 months
    Secondary Outcome Measure Information:
    Title
    Change in modified sulcus bleeding index
    Description
    scale 0-3
    Time Frame
    baseline, 6 & 12 months
    Title
    Change in Plaque index
    Description
    scale 0-3
    Time Frame
    baseline, 6 & 12 months
    Title
    Change in pocket probing depth
    Description
    measured in mm
    Time Frame
    baseline, 6 & 12 months
    Title
    Change in relative vertical clinical attachment level
    Description
    measured in mm
    Time Frame
    baseline, 6 & 12 months
    Title
    Change in relative horizontal clinical attachment level
    Description
    measured in mm
    Time Frame
    baseline, 6 & 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria:Systemically healthy patients with mandibular class II furcation defects and asymptomatic endodontically vital mandibular molars with radiolucency in furcation area with PD ≥ 5mm and horizontal PD ≥ 3mm and with no history of antibiotic or any periodontal therapy in past 6 months were included in the study - Exclusion Criteria:Subjects with any known systemic disease, allergic to alendronate or aloe vera, on systemic alendronate therapy, alcoholics, tobacco users, pregnant or lactating women -

    12. IPD Sharing Statement

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    Local Host Modulating Agents Alendronate & Aloe Vera for Treatment of Furcation Defects in Chronic Periodontitis

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