Topical Chlorhexidine and Metronidazole Gels for Gingival Inflammation

NCT07776197 | Completed

• 1 other identifier: HFW(GDC)B(12)50/2015-Vol-II
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled clinical trial was undertaken to evaluate and compare the effectiveness of chlorhexidine gluconate gel (1%) alone and a combination gel containing chlorhexidine gluconate (0.5%) with metronidazole (1.5%) as adjuncts to scaling and root planing in the management of gingival inflammation over a period of 12 weeks. 120 participants were assigned to three groups: scaling and root planing with placebo gel, scaling and root planing with 1% chlorhexidine gluconate gel, and scaling and root planing with a combination of 0.5% chlorhexidine gluconate and 1.5% metronidazole gel. Clinical periodontal parameters were assessed to compare the effectiveness of the interventions in reducing plaque accumulation and gingival inflammation.

Conditions

Plaque Induced Gingivitis

Keywords

Chlorhexidine; Metronidazole; Topical gel; Scaling and root planing; Plaque index; Gingival index

Outcome Measures

Primary Outcomes (3)

• Change in plaque index (PI)

  "Plaque accumulation was assessed using the Silness and Löe Plaque Index. Scores range from 0 to 3, with higher scores indicating greater plaque accumulation and therefore a worse outcome. Change was assessed from baseline to 12 weeks."

  Baseline and 12 Weeks

• Change in gingival index (GI)

  "Gingival inflammation was assessed using the Löe and Silness Gingival Index. Scores range from 0 to 3, with higher scores indicating greater gingival inflammation and therefore a worse outcome. Change was assessed from baseline to 12 weeks."

  Baseline and 12 weeks

• Change in Periodontal probing depth (PPD)

  Periodontal probing depth was measured in millimeters using a periodontal probe to evaluate changes in periodontal pocket depth following the assigned intervention.

  Baseline and 12 weeks

Study Arms (3)

Placebo group (control group)

PLACEBO COMPARATOR

Participants received supragingival and subgingival scaling followed by topical application of placebo gel. Participants were instructed to apply a pea-sized amount of gel gently to the gingiva after brushing for approximately two minutes, twice daily for 6 weeks.

Drug: Placebo Gel

Test Group1- Chlorhexidine

EXPERIMENTAL

Participants received supragingival and subgingival scaling followed by topical application of 1% chlorhexidine gluconate gel. The gel was applied twice daily for 6 weeks.

Drug: Chlorhexidine Gluconate Gel 1%

Test Group 2- Chlorhexidine + Metronidazole

EXPERIMENTAL

Participants received supragingival and subgingival scaling followed by topical application of a combination of 0.5% chlorhexidine gluconate gel and 1.5% metronidazole gel. The gel was applied twice daily for 6 weeks.

Drug: Chlorhexidine Gluconate 0.5% + Metronidazole 1.5% Gel

Interventions

Chlorhexidine Gluconate Gel 1% DRUG

Topical 1% chlorhexidine gluconate gel was applied to the gingiva in a pea-sized amount after brushing for approximately two minutes, twice daily for 6 weeks.

Test Group1- Chlorhexidine

Chlorhexidine Gluconate 0.5% + Metronidazole 1.5% Gel DRUG

A topical combination of 0.5% chlorhexidine gluconate gel and 1.5% metronidazole gel was applied to the gingiva in a pea-sized amount after brushing for approximately two minutes, twice daily for 6 weeks.

Test Group 2- Chlorhexidine + Metronidazole

Placebo Gel DRUG

Topical placebo gel was applied to the gingiva in a pea-sized amount after brushing for approximately two minutes, twice daily for 6 weeks.

Placebo group (control group)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged between 18- 50 years.
• Patients with at least \>20 teeth.
• Patients with gingivitis and stage-1 grade A periodontitis.
• Patients with clinical criteria of gingival index ≥ 1 (Loe and Silness).
• Systematically healthy patient with no co-morbidities.
• History of no active periodontal treatment in the last 6 months.

You may not qualify if:

• History of smoking or use of smokeless tobacco.
• Pregnant or lactating females.
• Subjects with removal or fixed dental prosthesis and undergoing orthodontic treatment.
• Use of antibiotics in the last 30 days.
• Subjects with hematological disorders, immunocompromised and any other systemic illnesses.
• History of chronic alcoholism.
• Allergic to Metronidazole or Chlorhexidine.
• Patients on medications that have effects on gingival enlargements.

Sponsors & Collaborators

• H.P. Government Dental College and Hospital Shimla: lead

Study Sites (1)

Government Dental College and Hospital, Shimla

Shimla, Himachal Pradesh, 171001, India

Location

MeSH Terms

Interventions

chlorhexidine gluconate; Metronidazole; Gels

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The intervention tubes were covered with opaque labels and coded as A, B, and C by an individual not directly involved in treatment. The tubes were dispensed according to a computer generated randomization sequence, and the principal investigator/operator was unaware of the treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate student, Department of Periodontology

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 20, 2026
• Study Start: May 16, 2025
• Primary Completion: November 26, 2025
• Study Completion: November 26, 2025
• Last Updated: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)