- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07135674
- Original Trial
Evaluation of a Herbal Antiseptic Gel as a Supportive Treatment for Teeth Cleaning in Patients With Periodontal Disease
Evaluation of Thermoreversible Avocado-based Gel as an Adjunct to Scaling and Root Planing in Chronic Periodontitis Patients: A Clinical And Microbiological Study
The goal of this clinical trial is to learn if the herbal gel is more effective as compared to placebo in reducing periodontal inflammation in patients with periodontal disease.
The clinicians shall check various periodontal parameters in the subjects over a scheduled duration.
Participants will be administered the gel once subgingivally and the periodontal parameters shall be recorded before gel delivery then again after 1,3 and 6 months.
Plaque samples were taken at baseline and 6 months
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Chronic periodontitis is a prevalent inflammatory condition primarily caused by bacterial plaque biofilm, leading to progressive attachment and bone loss. Scaling and root planing (SRP) is the gold standard for its management. Recently, natural and herbal-based adjuncts have gained attention for their antimicrobial and anti-inflammatory properties. This study aimed to evaluate the clinical and microbiological effectiveness of 4% avocado gel as an adjunct to SRP in the treatment of chronic periodontitis.
A randomized controlled clinical trial was conducted on patients diagnosed with chronic periodontitis. Subjects were divided into two groups: Group I received SRP with subgingival application of placebo gel, and Group II received SRP along with subgingival application of 4% avocado gel. Clinical parameters, including Plaque Index (PI), Papilla Bleeding Index (PBI), Probing Pocket Depth (PPD), and Relative Attachment Level (RAL), were recorded at baseline and after 4th week and 12th week. Microbiological analysis was conducted at recorded at baseline, 4th week,12th week and 24th week to assess the presence of Porphyromonas gingivalis and Prevotella intermedia using culture methods.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Chhattisgarh
-
Durg, Chhattisgarh, India, 490024
- Rungta College of Dental Sciences and Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria: 1. Patients with Chronic periodontitis having periodontal pockets (non-adjacent sites) of >5mm
Exclusion Criteria:
- history of any systemic disease, Antibiotic treatment during the 6 months period prior to the study, Pregnant and lactating woman, Periodontal treatment during the previous 3 months, Severe caries or extensive restoration on the objective teeth.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: scaling and root planing with subgingival application of placebo gel
scaling and root planing of the entire dentition followed by subgingival application of placebo gel in selected site
|
local drug delivery of placebo gel
|
|
Experimental: scaling and root planing with subgingival application of thermoreversible herbal gel
scaling and root planing of the entire dentition followed by subgingival application of herbal gel in selected site
|
local drug delivery of herbal gel
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Plaque Index
Time Frame: 3 months
|
3 months
|
|
Papilla Bleeding Index
Time Frame: 3 months
|
3 months
|
|
Probing Pocket Depth
Time Frame: 3 months
|
3 months
|
|
Relative Attachment Level
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CFUs
Time Frame: 6 months
|
Colony Forming Units
|
6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RCDSR/IEC/MDS/2023/D-37
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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