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

Phase 4

Completed

• Conditions: Diabetes Mellitus; Chronic Periodontitis
• Interventions: Drug: SRP + Aloe; Procedure: SRP

• Registration Number: NCT02437747
• Lead Sponsor: Dr. D. Y. Patil Dental College & Hospital

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.

Study Timeline

• Study Start: 2014-06
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Study First Submitted: 2015-04-29
• Status Verified: 2015-05
• Study First Submitted QC: 2015-05-05
• Last Update Submitted: 2015-05-05
• Study First Posted: 2015-05-08
• Last Update Posted: 2015-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SRP+ Aloe Group	SRP + Aloe	Scaling and root planing was done along with application of aloe vera gel as an adjunct in selected sites.
SRP Group	SRP	Only scaling and root planing was done on the opposite side.

Primary Outcome Measures

Name	Time	Method
Clinical parameter of probing pocket depth	3 months	Clinically change in the probing pocket depth.

Secondary Outcome Measures

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