Chronic Gingivitis, Plaque InducedNCT07059572
Comparative Evaluation of Guava Leaf Extract and Chlorhexidine Mouthwash in Patients With Chronic Gingivitis
A study testing Group A- 0.15% Guava leaf extract mouthwash group and Group B- 0.2% Chlorhexidine mouthwash in people with Chronic Gingivitis, Plaque Induced, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial summary
The goal of this clinical trial is to compare the effectiveness of 0.15% guava (Psidium guajava) leaf extract mouth rinse with 0.2% Chlorhexidine (CHX) mouth rinse in reducing plaque accumulation, gingival inflammation, and oral microbial load in participants with plaque-induced chronic moderate or severe gingivitis. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Chronic Gingivitis, Plaque Induced
- What is being tested?
- Group A- 0.15% Guava leaf extract mouthwash group and Group B- 0.2% Chlorhexidine mouthwash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteBangladesh
- Study dates
- 27 May 2025to 30 Oct 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Systemically compromised people; subjects with removable or fixed orthodontic appliances or prosthesis.
- People who were prescribed antibiotics or inflammatory drugs in the past 1 month.
- History of smoking or any form of tobacco use.
- History of allergic reactions to Chlorhexidine or Guava.
- Severe systemic conditions that could contraindicate participation in the study.
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
Bangabandhu Sheikh Mujib Medical University
Dhaka, Dhaka Division, 1000
About this study
The goal of this clinical trial is to compare the effectiveness of 0.15% guava (Psidium guajava) leaf extract mouth rinse with 0.2% Chlorhexidine (CHX) mouth rinse in reducing plaque accumulation, gingival inflammation, and oral microbial load in participants with plaque-induced chronic moderate or severe gingivitis. Half of the participants will receive guava leaf extract mouth rinse, and the other half will receive Chlorhexidine(CHX).
Read the detailed description
Plaque-induced gingivitis is one of the most prevalent oral health problems worldwide and, if not addressed, can progress to periodontitis with irreversible loss of supporting tissues. Although mechanical plaque control through tooth-brushing and flossing is essential, many individuals do not achieve adequate plaque removal, so antimicrobial mouth rinses are commonly prescribed as adjuncts. The standard 0.2 % chlorhexidine (CHX) rinse is effective yet limited by tooth staining, taste alteration, and mucosal irritation, prompting interest in safer natural options. Psidium guajava (guava) leaf extract contains flavonoids, tannins, and other bioactive compounds with documented antimicrobial, anti-inflammatory, and antioxidant properties and has shown promise as a natural oral-care agent. This clinical trial will be conducted in the Out-patient Department and will enrol 160 adults with plaque-induced chronic moderate or severe gingivitis selected by purposive sampling method. After baseline non-surgical periodontal therapy, participants will be allocated to an intervention group that receives a 0.15 % guava-leaf extract mouth rinse or to a control group that receives a 0.2 % Chlorhexidine(CHX) mouth rinse; each participant will rinse with 10 mL twice daily, 30 minutes after brushing, for three months. Plaque Index (Turesky modification of Quigley-Hein) and Gingival Index (Löe \& Silness) will be recorded at baseline, one month, and three months to gauge changes in plaque accumulation and gingival inflammation. To explore antimicrobial performance, the study will determine zones of inhibition and minimum inhibitory concentration (MIC) values for each rinse. Participants will also complete structured questionnaires on taste, staining, burning sensation, and overall acceptability, and any adverse events will be documented. Findings from this trial will clarify whether guava-leaf mouth rinse offers clinical and antimicrobial benefits comparable to, or better than, Chlorhexidine(CHX) while avoiding its common side-effects, potentially providing a locally sourced, culturally acceptable, and affordable adjunct for managing gingivitis in Bangladesh and similar settings.
- Conditions
- Chronic Gingivitis, Plaque Induced
- Being tested
- Group A- 0.15% Guava leaf extract mouthwash group, Group B- 0.2% Chlorhexidine mouthwash
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A- 0.15% Guava leaf extract mouthwash groupDrug
Participants will be instructed to rinse with 10 ml of 0.15% Guava Leaf Extract Mouthwash twice daily for 30 and 90 days. Each rinse will last for 1 minute, after which the mouthwash is to be expectorated without swallowing.
Group B- 0.2% Chlorhexidine mouthwashDrug
Participants will be instructed to rinse with 10 ml of 0.2% Chlorhexidine Mouthwash twice daily for 30 and 90 days. Each rinse will last for 1 minute, after which the mouthwash is to be expectorated without swallowing."
| Study group | Role | What they receive |
|---|---|---|
| Group B-0.2% Chlorhexidine mouthwash group | Active comparator | Participants will be instructed to rinse with 10 ml of 0.2% Chlorhexidine Mouthwash twice daily for 30 and 90 days. Each rinse will last for 1 minute, after which the mouthwash is to be expectorated without swallowing. Receives: Drug: Group B- 0.2% Chlorhexidine mouthwash |
| Group A- 0.15% Guava Leaf Extract Mouthwash | Experimental | Participants will be instructed to rinse with 10 ml of 0.15% Guava Leaf Extract Mouthwash twice daily for 30 and 90 days. Each rinse will last for 1 minute, after which the mouthwash is to be expectorated without swallowing. Receives: Drug: Group A- 0.15% Guava leaf extract mouthwash group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Plaque Index
Plaque Index (PI) will be assessed using the Turesky-Gilmore-Glickman modification of the Quigley-Hein index. This index measures the extent of dental plaque accumulation on six surfaces per tooth and assigns scores from 0 (no plaque) to 5 (plaque covering more than two-thirds of the surface). The average PI score will be calculated for each participant and compared over time to determine the plaque-reducing efficacy of guava leaf extract versus 0.2% chlorhexidine.
Measured: At baseline, 1 month, and 3 months post-intervention
Change in Gingival Index (GI)
Gingival Index (GI) will be used to assess the degree of gingival inflammation. It will be measured using the Löe and Silness index, which scores each gingival unit (mesial, distal, buccal, and lingual) on a scale from 0 to 3. A score of 0 indicates normal gingiva, while 3 indicates severe inflammation with marked redness, edema, ulceration, and spontaneous bleeding. The mean GI score will be compared across the three time points to evaluate the anti-inflammatory effects of guava leaf extract versus 0.2% chlorhexidine mouthwash.
Measured: At Baseline, 1 Month, and 3 Months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start27 May 2025
- Primary completion30 Oct 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Gingivitis, Plaque InducedStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Shakila Jahan Nabila, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059572
- Sponsor's protocol ID
- 5516
- Status last verified
- Feb 2026
- First submitted
- 1 Jul 2025
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Guava Leaf Extract and Chlorhexidine Mouthwash in Patients With Chronic Gingivitis
- ClinicalTrials.gov ID
- NCT07059572
- Acronym / sponsor ID
- 5516
- Conditions
- Chronic Gingivitis, Plaque Induced
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- 27 May 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 11 Jul 2025 (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.
The goal of this clinical trial is to compare the effectiveness of 0.15% guava (Psidium guajava) leaf extract mouth rinse with 0.2% Chlorhexidine (CHX) mouth rinse in reducing plaque accumulation, gingival inflammation, and oral microbial load in participants with plaque-induced chronic moderate or severe gingivitis. Half of the participants will receive guava leaf extract mouth rinse, and the other half will receive Chlorhexidine(CHX).
Detailed description
Plaque-induced gingivitis is one of the most prevalent oral health problems worldwide and, if not addressed, can progress to periodontitis with irreversible loss of supporting tissues. Although mechanical plaque control through tooth-brushing and flossing is essential, many individuals do not achieve adequate plaque removal, so antimicrobial mouth rinses are commonly prescribed as adjuncts. The standard 0.2 % chlorhexidine (CHX) rinse is effective yet limited by tooth staining, taste alteration, and mucosal irritation, prompting interest in safer natural options. Psidium guajava (guava) leaf extract contains flavonoids, tannins, and other bioactive compounds with documented antimicrobial, anti-inflammatory, and antioxidant properties and has shown promise as a natural oral-care agent. This clinical trial will be conducted in the Out-patient Department and will enrol 160 adults with plaque-induced chronic moderate or severe gingivitis selected by purposive sampling method. After baseline non-surgical periodontal therapy, participants will be allocated to an intervention group that receives a 0.15 % guava-leaf extract mouth rinse or to a control group that receives a 0.2 % Chlorhexidine(CHX) mouth rinse; each participant will rinse with 10 mL twice daily, 30 minutes after brushing, for three months. Plaque Index (Turesky modification of Quigley-Hein) and Gingival Index (Löe \& Silness) will be recorded at baseline, one month, and three months to gauge changes in plaque accumulation and gingival inflammation. To explore antimicrobial performance, the study will determine zones of inhibition and minimum inhibitory concentration (MIC) values for each rinse. Participants will also complete structured questionnaires on taste, staining, burning sensation, and overall acceptability, and any adverse events will be documented. Findings from this trial will clarify whether guava-leaf mouth rinse offers clinical and antimicrobial benefits comparable to, or better than, Chlorhexidine(CHX) while avoiding its common side-effects, potentially providing a locally sourced, culturally acceptable, and affordable adjunct for managing gingivitis in Bangladesh and similar settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group B-0.2% Chlorhexidine mouthwash group | Active comparator | Drug: Group B- 0.2% Chlorhexidine mouthwashParticipants will be instructed to rinse with 10 ml of 0.2% Chlorhexidine Mouthwash twice daily for 30 and 90 days. Each rinse will last for 1 minute, after which the mouthwash is to be expectorated without swallowing. |
| Group A- 0.15% Guava Leaf Extract Mouthwash | Experimental | Drug: Group A- 0.15% Guava leaf extract mouthwash groupParticipants will be instructed to rinse with 10 ml of 0.15% Guava Leaf Extract Mouthwash twice daily for 30 and 90 days. Each rinse will last for 1 minute, after which the mouthwash is to be expectorated without swallowing. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Systemically compromised people; subjects with removable or fixed orthodontic appliances or prosthesis.
- People who were prescribed antibiotics or inflammatory drugs in the past 1 month.
- History of smoking or any form of tobacco use.
- History of allergic reactions to Chlorhexidine or Guava.
- Severe systemic conditions that could contraindicate participation in the study.
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 |
|---|---|---|
| Group A- 0.15% Guava leaf extract mouthwash groupParticipants will be instructed to rinse with 10 ml of 0.15% Guava Leaf Extract Mouthwash twice daily for 30 and 90 days. Each rinse will last for 1 minute, after which the mouthwash is to be expectorated without swallowing. | Drug | Group A- 0.15% Guava Leaf Extract Mouthwash |
| Group B- 0.2% Chlorhexidine mouthwashParticipants will be instructed to rinse with 10 ml of 0.2% Chlorhexidine Mouthwash twice daily for 30 and 90 days. Each rinse will last for 1 minute, after which the mouthwash is to be expectorated without swallowing." | Drug | Group B-0.2% Chlorhexidine mouthwash group |
Primary outcome
Change in Plaque Index
Time frame: At baseline, 1 month, and 3 months post-intervention
Plaque Index (PI) will be assessed using the Turesky-Gilmore-Glickman modification of the Quigley-Hein index. This index measures the extent of dental plaque accumulation on six surfaces per tooth and assigns scores from 0 (no plaque) to 5 (plaque covering more than two-thirds of the surface). The average PI score will be calculated for each participant and compared over time to determine the plaque-reducing efficacy of guava leaf extract versus 0.2% chlorhexidine.
Change in Gingival Index (GI)
Time frame: At Baseline, 1 Month, and 3 Months post-intervention
Gingival Index (GI) will be used to assess the degree of gingival inflammation. It will be measured using the Löe and Silness index, which scores each gingival unit (mesial, distal, buccal, and lingual) on a scale from 0 to 3. A score of 0 indicates normal gingiva, while 3 indicates severe inflammation with marked redness, edema, ulceration, and spontaneous bleeding. The mean GI score will be compared across the three time points to evaluate the anti-inflammatory effects of guava leaf extract versus 0.2% chlorhexidine mouthwash.
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 18 Feb 2026.
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 Group A- 0.15% Guava leaf extract mouthwash group and Group B- 0.2% Chlorhexidine mouthwash in people with Chronic Gingivitis, Plaque Induced, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
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 0 inclusion and 5 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 18 Feb 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 Bangladesh. 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. 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 (time frame: At baseline, 1 month, and 3 months post-intervention). The study lists 2 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 18 Feb 2026.