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Locally Delivered Aloe Vera Gel in the Treatment of Chronic Periodontitis Patients With Diabetes Mellitus

Primary Purpose

Diabetes Mellitus, Chronic Periodontitis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
SRP + Aloe
SRP
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 Diabetes Mellitus focused on measuring clinical trial

Eligibility Criteria

30 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients age 30 - 55 years from both genders.
  2. Patients with controlled Type II Diabetes Mellitus (HbA1c < 7%) with Chronic periodontitis having ≥ 5mm periodontal pockets bilaterally atleast in one site.
  3. Patients on oral hypoglycaemic agents.
  4. Subjects who have not received periodontal therapy within preceding 6 months.
  5. Patients willing to comply with all study related procedures.

Exclusion Criteria:

  1. Subjects who have received antibiotic treatment in the preceding 3 months.
  2. History of prolonged use of antibiotics/ steroids/ immunosuppressive agents /aspirin/ anticoagulants/ other medications including any other herbal products.
  3. Pregnant or lactating women.
  4. Smokers.
  5. History of systemic diseases like hypertension, HIV, bone metabolic disorders, radiation therapy, Osteoporosis, immunosuppressive therapy, cancer etc.other than Diabetes.
  6. Unwilling patients

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    SRP+ Aloe Group

    SRP Group

    Arm Description

    Scaling and root planing was done along with application of aloe vera gel as an adjunct in selected sites.

    Only scaling and root planing was done on the opposite side.

    Outcomes

    Primary Outcome Measures

    Clinical parameter of probing pocket depth
    Clinically change in the probing pocket depth.

    Secondary Outcome Measures

    Glycosylated haemoglobin
    HbA1c levels evaluated at baseline and 3 months
    Clinical parameter of plaque index
    Change in the plaque index.
    Clinical parameter of gingival index
    Change in the gingival index.
    Clinical parameter of relative attachment level
    Change in the relative attachment level.

    Full Information

    First Posted
    April 29, 2015
    Last Updated
    May 5, 2015
    Sponsor
    Dr. D. Y. Patil Dental College & Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02437747
    Brief Title
    Locally Delivered Aloe Vera Gel in the Treatment of Chronic Periodontitis Patients With Diabetes Mellitus
    Official Title
    Local Drug Delivery of Aloe Vera Gel in Chronic Periodontitis Patients With Controlled Diabetes Mellitus
    Study Type
    Interventional

    2. Study Status

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

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    A study on the effect of locally delivered aloe vera gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis patients with controlled type II diabetes mellitus.The evaluation of Plaque Index, Gingival Index, Probing Pocket Depth, Relative Attachment Level at baseline, 6 weeks and 3 months and Glycosylated heamoglobin at baseline and 3 months.
    Detailed Description
    Aloe vera gel was locally delivered in the periodontal pockets of ≥ 5mm bilaterally in chronic periodontitis patients with diabetes under control.(HbA1c-6.6-8.6%).The study design had two groups-one in which scaling and root planing and local delivery of aloe vera gel and the other only scaling and root planing. The evaluation of clinical parameters of PI, GI, PPD and RAL at baseline, 6 weeks and 3 months. HbA1c evaluated at baseline and 3 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Chronic Periodontitis
    Keywords
    clinical trial

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    15 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SRP+ Aloe Group
    Arm Type
    Experimental
    Arm Description
    Scaling and root planing was done along with application of aloe vera gel as an adjunct in selected sites.
    Arm Title
    SRP Group
    Arm Type
    Sham Comparator
    Arm Description
    Only scaling and root planing was done on the opposite side.
    Intervention Type
    Drug
    Intervention Name(s)
    SRP + Aloe
    Other Intervention Name(s)
    Korphad Ghar
    Intervention Description
    Scaling and root planing along with aloe vera application was done
    Intervention Type
    Procedure
    Intervention Name(s)
    SRP
    Intervention Description
    Scaling and root planing was done
    Primary Outcome Measure Information:
    Title
    Clinical parameter of probing pocket depth
    Description
    Clinically change in the probing pocket depth.
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Glycosylated haemoglobin
    Description
    HbA1c levels evaluated at baseline and 3 months
    Time Frame
    3 months
    Title
    Clinical parameter of plaque index
    Description
    Change in the plaque index.
    Time Frame
    3 months
    Title
    Clinical parameter of gingival index
    Description
    Change in the gingival index.
    Time Frame
    3 months
    Title
    Clinical parameter of relative attachment level
    Description
    Change in the relative attachment level.
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients age 30 - 55 years from both genders. Patients with controlled Type II Diabetes Mellitus (HbA1c < 7%) with Chronic periodontitis having ≥ 5mm periodontal pockets bilaterally atleast in one site. Patients on oral hypoglycaemic agents. Subjects who have not received periodontal therapy within preceding 6 months. Patients willing to comply with all study related procedures. Exclusion Criteria: Subjects who have received antibiotic treatment in the preceding 3 months. History of prolonged use of antibiotics/ steroids/ immunosuppressive agents /aspirin/ anticoagulants/ other medications including any other herbal products. Pregnant or lactating women. Smokers. History of systemic diseases like hypertension, HIV, bone metabolic disorders, radiation therapy, Osteoporosis, immunosuppressive therapy, cancer etc.other than Diabetes. Unwilling patients
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Archana Singh, MDS
    Organizational Affiliation
    Dr.D.Y.Patil Vidyapeeth
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    Locally Delivered Aloe Vera Gel in the Treatment of Chronic Periodontitis Patients With Diabetes Mellitus

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