- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02462993
Local Drug Delivery of Aloe Vera Gel in Chronic Periodontitis
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 Overview
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 Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Aloe vera group
Group recieving scaling and root planing and aloe vera gel local drug delivery
|
Local drug delivery of aloe vera gel
|
No Intervention: SRP group
Group recieving only scaling and root planing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Relative Attachment Loss was taken as the primary outcome
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Probing depth
Time Frame: 3 months
|
3 months
|
Change in number of microbial species
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Krupa H Pathak, Post Graduate
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DYPCH/12/PG14
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Periodontitis
-
Azienda Socio Sanitaria Territoriale degli Spedali...Università degli Studi di FerraraCompletedPeriodontitis, Aggressive | Periodontitis, AdultItaly
-
Panineeya Mahavidyalaya Institute of Dental Sciences...Research Institute for Genetic and Human TherapyUnknownGeneralized Adult Periodontitis
-
Asem Mohammed Kamel AliCompletedMolar-incisor Pattern Grade C Periodontitis ( Localized Aggressive Periodontitis) | Generalized Grade C Periodontitis (Generalized Aggressive Periodontitis)Egypt
-
Columbia UniversityCompletedPeriodontal Diseases | Generalized Moderate Chronic Periodontitis | Generalized Severe Chronic PeriodontitisUnited States
-
Aga Khan UniversityCompletedChronic Apical PeriodontitisPakistan
-
Postgraduate Institute of Dental Sciences RohtakUnknownChronic Apical PeriodontitisIndia
-
University Hospital, Strasbourg, FranceRecruitingPeriodontitis, AdultFrance
-
October University for Modern Sciences and ArtsCompletedPeriodontitis, AdultEgypt
-
Loma Linda UniversityTerminated
-
PiLeJeCompletedProbiotics, PeriodontitisFrance
Clinical Trials on Aloe Vera
-
University of ThessalyCompletedPerformance | Skeletal Muscle Damage | Exercise-induced Aseptic InflammationGreece
-
Universidad Autonoma de Nuevo LeonCompleted
-
University of MemphisMannatechCompletedMicrobiome | Immune FunctionUnited States
-
Government College of Dentistry, IndoreUnknown
-
Cairo UniversityUnknown
-
Ospedale Sandro Pertini, RomaCompletedAloe Vera Gel, Proctosigmoiditis, Remission, Trial, Ulcerative Colitis (UC)
-
NHS LothianUniversity of EdinburghWithdrawnInjuries and WoundsUnited Kingdom
-
Wake Forest University Health SciencesDesert HarvestNot yet recruitingInterstitial Cystitis | Bladder Pain Syndrome | Chronic Interstitial CystitisUnited States
-
Cairo UniversityUnknown
-
HealOrUnknown