Plaque Induced GingivitisNCT07776197
Topical Chlorhexidine and Metronidazole Gels for Gingival Inflammation
A study testing Chlorhexidine Gluconate Gel 1% and Chlorhexidine Gluconate 0.5% + Metronidazole 1.5% Gel in people with Plaque Induced Gingivitis, run by H.P. Government Dental College and Hospital Shimla at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Plaque Induced Gingivitis
- What is being tested?
- Chlorhexidine Gluconate Gel 1% and Chlorhexidine Gluconate 0.5% + Metronidazole 1.5% Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteIndia
- Study dates
- 16 May 2025to 26 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
India1 site
Government Dental College and Hospital, Shimla
Shimla, Himachal Pradesh, 171001
About this study
Official 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
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.
- Conditions
- Plaque Induced Gingivitis
- Being tested
- Chlorhexidine Gluconate Gel 1%, Chlorhexidine Gluconate 0.5% + Metronidazole 1.5% Gel, Placebo Gel
- Keywords
- Chlorhexidine, Metronidazole, Topical gel, Scaling and root planing, Plaque index, Gingival index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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% GelDrug
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 GelDrug
Topical placebo gel was applied to the gingiva in a pea-sized amount after brushing for approximately two minutes, twice daily for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo group (control group) | Placebo comparator | 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. Receives: Drug: Placebo Gel |
| Test Group1- Chlorhexidine | Experimental | Participants received supragingival and subgingival scaling followed by topical application of 1% chlorhexidine gluconate gel. The gel was applied twice daily for 6 weeks. Receives: Drug: Chlorhexidine Gluconate Gel 1% |
| Test Group 2- Chlorhexidine + Metronidazole | Experimental | 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. Receives: Drug: Chlorhexidine Gluconate 0.5% + Metronidazole 1.5% Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: Baseline and 12 Weeks
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."
Measured: Baseline and 12 weeks
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.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start16 May 2025
- Primary completion26 Nov 2025
- Study completion26 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque Induced GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- H.P. Government Dental College and Hospital Shimla
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Abhishek Sharma, H.P. Government Dental College and Hospital Shimla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07776197
- Sponsor's protocol ID
- HFW(GDC)B(12)50/2015-Vol-II
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07776197
- Acronym / sponsor ID
- HFW(GDC)B(12)50/2015-Vol-II
- Conditions
- Plaque Induced Gingivitis
- Keywords
- Chlorhexidine, Metronidazole, Topical gel, Scaling and root planing, Plaque index, Gingival index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- H.P. Government Dental College and Hospital ShimlaUniversity, hospital or other
- Study start
- 16 May 2025 (actual)
- Primary completion
- 26 Nov 2025 (actual)
- Study completion
- 26 Nov 2025 (actual)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo group (control group) | Placebo comparator | Drug: Placebo GelParticipants 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% GelParticipants 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlorhexidine 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. | Drug | Test Group1- Chlorhexidine |
| Chlorhexidine Gluconate 0.5% + Metronidazole 1.5% GelA 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. | Drug | Test Group 2- Chlorhexidine + Metronidazole |
| Placebo GelTopical placebo gel was applied to the gingiva in a pea-sized amount after brushing for approximately two minutes, twice daily for 6 weeks. | Drug | Placebo group (control group) |
Primary outcome
Change in plaque index (PI)
Time frame: 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)
Time frame: 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)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chlorhexidine Gluconate Gel 1% and Chlorhexidine Gluconate 0.5% + Metronidazole 1.5% Gel in people with Plaque Induced Gingivitis, run by H.P. Government Dental College and Hospital Shimla at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in plaque index (PI) (time frame: Baseline and 12 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.