Local Drug Delivery of Aloe Vera Gel in Chronic Periodontitis

Periodontitis Clinical Trial

Official title:

EFFECT OF LOCALLY DELIVERED ALOE VERA GEL AS AN ADJUNCT TO SCALING AND ROOT PLANING IN THE TREATMENT OF CHRONIC PERIODONTITIS: A SPLIT-MOUTH CLINICAL AND MICROBIOLOGICAL STUDY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02462993
• Other study ID #: DYPCH/12/PG14
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 29, 2015
• Last updated: June 3, 2015
• Start date: February 2014
• Est. completion date: May 2015

Study information

• Verified date: June 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

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 60 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Drug:
• Aloe Vera
Local drug delivery of aloe vera gel

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

References & Publications (2)

Bhat G, Kudva P, Dodwad V. Aloe vera: Nature's soothing healer to periodontal disease. J Indian Soc Periodontol. 2011 Jul;15(3):205-9. doi: 10.4103/0972-124X.85661. — View Citation

Perinetti G, Paolantonio M, Cordella C, D'Ercole S, Serra E, Piccolomini R. Clinical and microbiological effects of subgingival administration of two active gels on persistent pockets of chronic periodontitis patients. J Clin Periodontol. 2004 Apr;31(4):2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Relative Attachment Loss was taken as the primary outcome		3 months	No
Secondary	Change in Probing depth		3 months	No
Secondary	Change in number of microbial species		3 months	No