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

R

Rungta College of Dental Sciences and Research

Status and phase

Completed
Phase 4

Conditions

Periodontal Diseases

Treatments

Drug: placebo gel
Drug: herbal drug

Study type

Interventional

Funder types

Other

Identifiers

NCT07135674
RCDSR/IEC/MDS/2023/D-37

Details and patient eligibility

About

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

Full 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.

Enrollment

50 patients

Sex

All

Ages

25 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

50 participants in 2 patient groups, including a placebo group

scaling and root planing with subgingival application of placebo gel
Placebo Comparator group
Description:
scaling and root planing of the entire dentition followed by subgingival application of placebo gel in selected site
Treatment:
Drug: placebo gel
scaling and root planing with subgingival application of thermoreversible herbal gel
Experimental group
Description:
scaling and root planing of the entire dentition followed by subgingival application of herbal gel in selected site
Treatment:
Drug: herbal drug

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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