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Local Drug Delivery of Aloe Vera Gel in Chronic Periodontitis

Primary Purpose

Periodontitis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Aloe Vera
Sponsored by
Dr. D. Y. Patil Dental College & Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Inclusion in this study was based on the following criteria:

    1. Patients with age group between 30 - 60 years from both sexes.
    2. Chronic periodontitis patients with at least 1 pair of periodontal pocket ≥ 5mm in contra-lateral quadrants.

Exclusion Criteria:

  • Exclusion criteria were:

    1. Subjects who have received antibiotic treatment in the preceding 6 months.
    2. Patients with history of prolonged use of antibiotics/ steroids/ immunosuppressive agents /aspirin/ anticoagulants/ other medications including any herbal products.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Aloe vera group

    SRP group

    Arm Description

    Group recieving scaling and root planing and aloe vera gel local drug delivery

    Group recieving only scaling and root planing

    Outcomes

    Primary Outcome Measures

    Change in Relative Attachment Loss was taken as the primary outcome

    Secondary Outcome Measures

    Change in Probing depth
    Change in number of microbial species

    Full Information

    First Posted
    May 29, 2015
    Last Updated
    June 3, 2015
    Sponsor
    Dr. D. Y. Patil Dental College & Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02462993
    Brief Title
    Local Drug Delivery of Aloe Vera Gel in Chronic Periodontitis
    Official Title
    EFFECT OF LOCALLY DELIVERED ALOE VERA GEL AS AN ADJUNCT TO SCALING AND ROOT PLANING IN THE TREATMENT OF CHRONIC PERIODONTITIS: A SPLIT-MOUTH CLINICAL AND MICROBIOLOGICAL STUDY
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2014 (undefined)
    Primary Completion Date
    August 2014 (Actual)
    Study Completion Date
    May 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Dr. D. Y. Patil Dental College & Hospital

    4. Oversight

    5. Study Description

    Brief Summary
    Background: Aloe vera is considered to be the most promising and high-ranking agent as an all-purpose herbal plant amongst herbal agents used in dentistry. This study was designed to evaluate the clinical and microbiological effectiveness of locally delivered aloe vera gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.
    Detailed Description
    Background: Aloe vera is considered to be the most promising and high-ranking agent as an all-purpose herbal plant amongst herbal agents used in dentistry. This study was designed to evaluate the clinical and microbiological effectiveness of locally delivered aloe vera gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis. Methods: Twelve subjects diagnosed with chronic generalized periodontitis were selected and randomly divided into two groups: Test group which received scaling and root planning (SRP) followed by application of aloe vera gel as a local drug delivery agent in the deepest periodontal pocket and control group which received SRP alone. Clinical evaluation was undertaken using Plaque index (PI), Gingival index (GI), Probing pocket depth (PPD), Relative attachment level (RAL) and Gingival marginal level (GML) and microbiologic counts (total colony count/ml) were assessed at baseline, 6 weeks and 3 months.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Aloe vera group
    Arm Type
    Experimental
    Arm Description
    Group recieving scaling and root planing and aloe vera gel local drug delivery
    Arm Title
    SRP group
    Arm Type
    No Intervention
    Arm Description
    Group recieving only scaling and root planing
    Intervention Type
    Drug
    Intervention Name(s)
    Aloe Vera
    Intervention Description
    Local drug delivery of aloe vera gel
    Primary Outcome Measure Information:
    Title
    Change in Relative Attachment Loss was taken as the primary outcome
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Change in Probing depth
    Time Frame
    3 months
    Title
    Change in number of microbial species
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Inclusion in this study was based on the following criteria: Patients with age group between 30 - 60 years from both sexes. Chronic periodontitis patients with at least 1 pair of periodontal pocket ≥ 5mm in contra-lateral quadrants. Exclusion Criteria: Exclusion criteria were: Subjects who have received antibiotic treatment in the preceding 6 months. Patients with history of prolonged use of antibiotics/ steroids/ immunosuppressive agents /aspirin/ anticoagulants/ other medications including any herbal products.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Krupa H Pathak
    Organizational Affiliation
    Post graduate
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22028505
    Citation
    Bhat G, Kudva P, Dodwad V. Aloe vera: Nature's soothing healer to periodontal disease. J Indian Soc Periodontol. 2011 Jul;15(3):205-9. doi: 10.4103/0972-124X.85661.
    Results Reference
    result
    PubMed Identifier
    15016256
    Citation
    Perinetti G, Paolantonio M, Cordella C, D'Ercole S, Serra E, Piccolomini R. Clinical and microbiological effects of subgingival administration of two active gels on persistent pockets of chronic periodontitis patients. J Clin Periodontol. 2004 Apr;31(4):273-81. doi: 10.1111/j.1600-051x.2004.00481.x.
    Results Reference
    result

    Learn more about this trial

    Local Drug Delivery of Aloe Vera Gel in Chronic Periodontitis

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