Skip to content

Topical Chlorhexidine and Metronidazole Gels for Gingival Inflammation

A Comparative Evaluation of Two Different Types of Commercially Available Topical Gels as an Adjunct to Scaling and Root Planing in Management of Gingival Inflammation - A Randomized Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07776197
Enrollment
120
Registered
2026-08-20
Start date
2025-05-16
Completion date
2025-11-26
Last updated
2026-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plaque Induced Gingivitis

Keywords

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

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.

Interventions

DRUGChlorhexidine Gluconate Gel 1%

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.

DRUGChlorhexidine Gluconate 0.5% + Metronidazole 1.5% Gel

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.

DRUGPlacebo Gel

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

Sponsors

H.P. Government Dental College and Hospital Shimla
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

1. Patients aged between 18- 50 years. 2. Patients with at least \>20 teeth. 3. Patients with gingivitis and stage-1 grade A periodontitis. 4. Patients with clinical criteria of gingival index ≥ 1 (Loe and Silness). 5. Systematically healthy patient with no co-morbidities. 6. History of no active periodontal treatment in the last 6 months.

Exclusion criteria

1. History of smoking or use of smokeless tobacco. 2. Pregnant or lactating females. 3. Subjects with removal or fixed dental prosthesis and undergoing orthodontic treatment. 4. Use of antibiotics in the last 30 days. 5. Subjects with hematological disorders, immunocompromised and any other systemic illnesses. 6. History of chronic alcoholism. 7. Allergic to Metronidazole or Chlorhexidine. 8. Patients on medications that have effects on gingival enlargements.

Design outcomes

Primary

MeasureTime frameDescription
Change in Periodontal probing depth (PPD)Baseline and 12 weeksPeriodontal probing depth was measured in millimeters using a periodontal probe to evaluate changes in periodontal pocket depth following the assigned intervention.
Change in plaque index (PI)Baseline and 12 Weeks"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."
Change in gingival index (GI)Baseline and 12 weeks"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."

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 22, 2026