Evaluation of a Herbal Antiseptic Gel as a Supportive Treatment for Teeth Cleaning in Patients With Periodontal Disease

NCT ID: NCT07135674

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-30
• Study Completion Date: 2025-05-30

Brief Summary

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

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.

Conditions

Periodontal Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: PLACEBO_COMPARATOR

placebo gel

Intervention Type: DRUG

local drug delivery of placebo gel

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

Group Type: EXPERIMENTAL

herbal drug

Intervention Type: DRUG

local drug delivery of herbal gel

Interventions

placebo gel

local drug delivery of placebo gel

Intervention Type: DRUG

herbal drug

local drug delivery of herbal gel

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rungta College of Dental Sciences and Research

OTHER

Sponsor Role: lead

Responsible Party

Karthik Krishna M

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rungta College of Dental Sciences and Research

Durg, Chhattisgarh, India

Countries

India

Other Identifiers

RCDSR/IEC/MDS/2023/D-37

Identifier Type: -

Identifier Source: org_study_id