Clinical trial NCT02462993: Local Drug Delivery of Aloe Vera Gel in Chronic Periodontitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Periodontitis
Lead sponsor: Dr. D. Y. Patil Dental College & Hospital
Sponsor class: OTHER
First posted: 2015-06-04
Enrollment: 12
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Relative Attachment Loss was taken as the primary outcome
timeFrame: 3 months
Secondary outcomes:
measure: Change in Probing depth
timeFrame: 3 months
measure: Change in number of microbial species
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Post graduate
name: Krupa H Pathak
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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):273-81. doi: 10.1111/j.1600-051x.2004.00481.x.