NCT07135674

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 30, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 22, 2025

Completed
Last Updated

August 22, 2025

Status Verified

July 1, 2025

Enrollment Period

1.8 years

First QC Date

August 14, 2025

Last Update Submit

August 14, 2025

Conditions

Periodontal Diseases

Keywords

periodontitisP. gingivalisP. intermedialocal drug delivery

Outcome Measures

Primary Outcomes (4)

  • Papilla Bleeding Index

    3 months

  • Plaque Index

    3 months

  • Probing Pocket Depth

    3 months

  • Relative Attachment Level

    3 months

Secondary Outcomes (1)

  • CFUs

    6 months

Study Arms (2)

scaling and root planing with subgingival application of placebo gel

PLACEBO COMPARATOR

scaling and root planing of the entire dentition followed by subgingival application of placebo gel in selected site

Drug: placebo gel

scaling and root planing with subgingival application of thermoreversible herbal gel

EXPERIMENTAL

scaling and root planing of the entire dentition followed by subgingival application of herbal gel in selected site

Drug: herbal drug

Interventions

placebo gelDRUG

local drug delivery of placebo gel

scaling and root planing with subgingival application of placebo gel
herbal drugDRUG

local drug delivery of herbal gel

scaling and root planing with subgingival application of thermoreversible herbal gel

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rungta College of Dental Sciences and Research

Durg, Chhattisgarh, 490024, India

Location

MeSH Terms

Conditions

Periodontal DiseasesPeriodontitis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 14, 2025

First Posted

August 22, 2025

Study Start

May 30, 2023

Primary Completion

March 30, 2025

Study Completion

May 30, 2025

Last Updated

August 22, 2025

Record last verified: 2025-07

Locations

IN(1)