Local Drug Delivery of Aloe Vera Gel in Chronic Periodontitis

Phase 2

Completed

• Conditions: Periodontitis
• Interventions: Drug: Aloe Vera

• Registration Number: NCT02462993
• Lead Sponsor: Dr. D. Y. Patil Dental College & Hospital

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.

Study Timeline

• Study Start: 2014-02
• Primary Completion: 2014-08
• Study Completion: 2015-05
• Study First Submitted: 2015-05-29
• Status Verified: 2015-06
• Study First Submitted QC: 2015-06-03
• Last Update Submitted: 2015-06-03
• Study First Posted: 2015-06-04
• Last Update Posted: 2015-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aloe vera group	Aloe Vera	Group recieving scaling and root planing and aloe vera gel local drug delivery

Primary Outcome Measures

Name	Time	Method
Change in Relative Attachment Loss was taken as the primary outcome	3 months

Secondary Outcome Measures

Name	Time	Method
Change in number of microbial species	3 months
Change in Probing depth	3 months