Topical Chlorhexidine and Metronidazole Gels for Gingival Inflammation

NCT07776197 — Not applicable, Completed, 120 participants, H.P. Government Dental College and Hospital Shimla

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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

Registry	NCT07776197
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	120 (Actual)
Sponsor	H.P. Government Dental College and Hospital Shimla (Other)
Conditions	Plaque Induced Gingivitis
Interventions	Chlorhexidine Gluconate Gel 1%, Chlorhexidine Gluconate 0.5% + Metronidazole 1.5% Gel, Placebo Gel (Drug)
Dates	start 2025-05-16, primary completion 2025-11-26, completion 2025-11-26, first posted 2026-08-20, last updated 2026-08-21
Locations	1 site in India

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Placebo group (control group)	Placebo comparator	Drug: Placebo Gel	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.
Test Group1- Chlorhexidine	Experimental	Drug: Chlorhexidine Gluconate Gel 1%	Participants received supragingival and subgingival scaling followed by topical application of 1% chlorhexidine gluconate gel. The gel was applied twice daily for 6 weeks.
Test Group 2- Chlorhexidine + Metronidazole	Experimental	Drug: Chlorhexidine Gluconate 0.5% + Metronidazole 1.5% Gel	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.

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.

+Outcome measures

Primary outcomes

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."
Change in Periodontal probing depth (PPD) [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.

+Eligibility

Sex: All, ages: 18 Years to 50 Years

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.

+Locations (1)

Facility	City	Country	Status
Government Dental College and Hospital, Shimla	Shimla, Himachal Pradesh	India