ClinicalTrials.gg
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

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled May 2025, registered Aug 2026).

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

Where this study stands

Counted across the records on this site · 2026-11-14

Among 18 studies in Gingivitis with a site in India — 1 open to participants now, 1 under way, none of them phase 3. Gingivitis · India.

Enrollment
Largest of 15
120 · median 60
Started
2025
with 2 others
No phase
12 of 18
1 open now
Registered
16th of 18
by date
Lead sponsor
1 of 18
H.P. Government Dental College and Hospital Shimla

Among the 18 studies in Gingivitis with a site in India, this one has the largest enrollment of the 15 interventional ones that give a count, is one of 3 that started in 2025, is one of 12 with no phase, and was the 16th registered.

Gingivitis

631 studies on the registry are indexed under Gingivitis; 107 are open to participants now.

Browse Gingivitis studies →

Open to participants now

1 of the 18 studies in Gingivitis with a site in India is open now. Recruiting first, the newest first:

A study can be open while its sites in India have not opened yet or have stopped. Only those recruiting at a site in India →

Who these studies take

Of the 53 Gingivitis studies recruiting now, 15 (28%) set no upper age limit and 36 (68%) stop at 75 or younger; 11 take children under 18; 35 take healthy volunteers.

This study: 18 Years to 50 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 18 studies in Gingivitis with a site in India, or all of them as a file.
02

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.

03

Conditions studied

  • Plaque Induced Gingivitis

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Keywords

  • Chlorhexidine
  • Metronidazole
  • Topical gel
  • Scaling and root planing
  • Plaque index
  • Gingival index
04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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, 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

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

  • 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

    Drug page: Chlorhexidine gluconate

    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.

06

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

07

Study locations

1 site
  • Government Dental College and Hospital, Shimla
    Shimla, Himachal Pradesh 171001, India
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2025 to primary completion in Nov 2025, 6 months.

Of 204 non-industry interventional studies with no phase under Gingivitis, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 18. This study's 6 months is below that.

Counting every sponsor, half of 257 studies reached it within 7 months; a quarter within 3 and three quarters within 15.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 17, 2026
First posted
Aug 20, 2026
StartActual
May 16, 2025
Primary completionActual
Nov 26, 2025
CompletionActual
Nov 26, 2025
Last update
Aug 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Chlorhexidine gluconate

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