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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02437747
• Other study ID #: DPU/431(7) /2014
• Status: Completed
• Phase: Phase 4
• First received: April 29, 2015
• Last updated: May 5, 2015
• Start date: June 2014
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: Dr. D. Y. Patil Dental College & Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Diabetes Mellitus
• Periodontitis

Intervention

Drug:
• SRP + Aloe
Scaling and root planing along with aloe vera application was done

Procedure:
• SRP
Scaling and root planing was done

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dr. D. Y. Patil Dental College & Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical parameter of probing pocket depth	Clinically change in the probing pocket depth.	3 months	Yes
Secondary	Glycosylated haemoglobin	HbA1c levels evaluated at baseline and 3 months	3 months	Yes
Secondary	Clinical parameter of plaque index	Change in the plaque index.	3 months	Yes
Secondary	Clinical parameter of gingival index	Change in the gingival index.	3 months	Yes
Secondary	Clinical parameter of relative attachment level	Change in the relative attachment level.	3 months	Yes