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

May 5, 2015 updated by: Dr. Gurbani Kaur, Dr. D. Y. Patil Dental College & Hospital

Local Drug Delivery of Aloe Vera Gel in Chronic Periodontitis Patients With Controlled Diabetes Mellitus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 4

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 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SRP+ Aloe Group
Scaling and root planing was done along with application of aloe vera gel as an adjunct in selected sites.
Drug: SRP + Aloe
Scaling and root planing along with aloe vera application was done
Other Names:
  • Korphad Ghar
Sham Comparator: SRP Group
Only scaling and root planing was done on the opposite side.
Procedure: SRP
Scaling and root planing was done

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical parameter of probing pocket depth
Time Frame: 3 months
Clinically change in the probing pocket depth.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycosylated haemoglobin
Time Frame: 3 months
HbA1c levels evaluated at baseline and 3 months
3 months
Clinical parameter of plaque index
Time Frame: 3 months
Change in the plaque index.
3 months
Clinical parameter of gingival index
Time Frame: 3 months
Change in the gingival index.
3 months
Clinical parameter of relative attachment level
Time Frame: 3 months
Change in the relative attachment level.
3 months

Collaborators and Investigators

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

Sponsor

Dr. D. Y. Patil Dental College & Hospital

Investigators

  • Study Director: Archana Singh, MDS, Dr.D.Y.Patil Vidyapeeth

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

June 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

April 29, 2015

First Submitted That Met QC Criteria

May 5, 2015

First Posted (Estimate)

May 8, 2015

Study Record Updates

Last Update Posted (Estimate)

May 8, 2015

Last Update Submitted That Met QC Criteria

May 5, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DPU/431(7) /2014

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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