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Completed

NCT Number: NCT07776197

Topical Chlorhexidine and Metronidazole Gels for Gingival Inflammation

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.

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Key information

Conditions

Plaque Induced Gingivitis

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Government Dental College and Hospital, Shimla

Shimla, Himachal Pradesh, 171001, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Change in plaque index (PI)

    Time frame: Baseline and 12 Weeks

    Plaque accumulation was assessed using the Plaque Index to evaluate changes in oral plaque following the assigned intervention.

  2. Change in gingival index (GI)

    Time frame: Baseline and 12 weeks

    Gingival inflammation was assessed using the Gingival Index to evaluate changes in gingival inflammation following the assigned intervention.

  3. Change in Periodontal probing depth (PPD)

    Time frame: Baseline and 12 weeks

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

Sponsors and collaborators

Lead sponsor

H.P. Government Dental College and Hospital Shimla

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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