Local Drug Delivery of Aloe Vera Gel in Chronic Periodontitis
Primary Purpose
Periodontitis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Aloe Vera
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis
Eligibility Criteria
Inclusion Criteria:
Inclusion in this study was based on the following criteria:
- Patients with age group between 30 - 60 years from both sexes.
- Chronic periodontitis patients with at least 1 pair of periodontal pocket ≥ 5mm in contra-lateral quadrants.
Exclusion Criteria:
Exclusion criteria were:
- Subjects who have received antibiotic treatment in the preceding 6 months.
- Patients with history of prolonged use of antibiotics/ steroids/ immunosuppressive agents /aspirin/ anticoagulants/ other medications including any herbal products.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Aloe vera group
SRP group
Arm Description
Group recieving scaling and root planing and aloe vera gel local drug delivery
Group recieving only scaling and root planing
Outcomes
Primary Outcome Measures
Change in Relative Attachment Loss was taken as the primary outcome
Secondary Outcome Measures
Change in Probing depth
Change in number of microbial species
Full Information
NCT ID
NCT02462993
First Posted
May 29, 2015
Last Updated
June 3, 2015
Sponsor
Dr. D. Y. Patil Dental College & Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02462993
Brief Title
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
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. D. Y. Patil Dental College & Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aloe vera group
Arm Type
Experimental
Arm Description
Group recieving scaling and root planing and aloe vera gel local drug delivery
Arm Title
SRP group
Arm Type
No Intervention
Arm Description
Group recieving only scaling and root planing
Intervention Type
Drug
Intervention Name(s)
Aloe Vera
Intervention Description
Local drug delivery of aloe vera gel
Primary Outcome Measure Information:
Title
Change in Relative Attachment Loss was taken as the primary outcome
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in Probing depth
Time Frame
3 months
Title
Change in number of microbial species
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Inclusion in this study was based on the following criteria:
Patients with age group between 30 - 60 years from both sexes.
Chronic periodontitis patients with at least 1 pair of periodontal pocket ≥ 5mm in contra-lateral quadrants.
Exclusion Criteria:
Exclusion criteria were:
Subjects who have received antibiotic treatment in the preceding 6 months.
Patients with history of prolonged use of antibiotics/ steroids/ immunosuppressive agents /aspirin/ anticoagulants/ other medications including any herbal products.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Krupa H Pathak
Organizational Affiliation
Post graduate
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
22028505
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.
Results Reference
result
PubMed Identifier
15016256
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.
Results Reference
result
Learn more about this trial
Local Drug Delivery of Aloe Vera Gel in Chronic Periodontitis
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