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CompletedNCT07776197Updated Aug 21, 2026

Topical Chlorhexidine and Metronidazole Gels for Gingival Inflammation

An interventional study of Chlorhexidine Gluconate Gel 1% and Chlorhexidine Gluconate 0.5% + Metronidazole 1.5% Gel in Plaque Induced Gingivitis, sponsored by H.P. Government Dental College and Hospital Shimla. Completed at 1 site in India. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by H.P. Government Dental College and Hospital Shimla · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Plaque Induced Gingivitis

Keywords

  • Chlorhexidine
  • Metronidazole
  • Topical gel
  • Scaling and root planing
  • Plaque index
  • Gingival index
03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts 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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
120 participants (actual)

Study arms

  • Placebo comparator
    Placebo group (control group)

    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

  • Experimental
    Test Group1- Chlorhexidine

    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%

  • Experimental
    Test Group 2- Chlorhexidine + Metronidazole

    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

  • 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.

05

What researchers measure

Primary outcomes

  1. 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."

    Time frame: Baseline and 12 Weeks

  2. 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."

    Time frame: Baseline and 12 weeks

  3. 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.

    Time frame: Baseline and 12 weeks

06

Study locations

1 site
  • Government Dental College and Hospital, Shimla
    Shimla, Himachal Pradesh 171001, India
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07776197
Lead sponsor
H.P. Government Dental College and Hospital Shimla
Responsible party
Dr. Abhishek Sharma (Postgraduate student, Department of Periodontology, H.P. Government Dental College and Hospital Shimla) — Principal investigator
First posted
Aug 20, 2026
Start date
May 16, 2025
Primary completion
Nov 26, 2025
Completion
Nov 26, 2025
Last update
Aug 21, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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