GingivitisPhase 3NCT07401069
Homemade Herbal Mouthwash in Gingivitis. A Randomized Clinical Trial.
A Phase 3 study testing Chlorhexidine 0,12% and herbal Mouthwash in people with Gingivitis, run by Cairo University.
Trial summary
Gingivitis is a very common oral disease that may progress to the more destructive periodontitis if not treated. As oral plaque is a key player in gingivitis, plaque control by professional scaling and oral hygiene measures represents the main line of treatment. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Gingivitis
- What is being tested?
- Chlorhexidine 0,12% and herbal Mouthwash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 30 Jul 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Plaque-induced gingivitis.
Who cannot join
- Medically compromised.
- History of medications.
- Pregnant females.
- Periapical involvement in teeth.
- History of periodontal surgery.
- If gingivitis was due to local factor.
About this study
Official title: The Effect of Homemade Herbal Mouthwash Versus Chlorhexidine on Plaque Accumulation in Gingivitis. A Randomized Clinical Trial.
Gingivitis is a very common oral disease that may progress to the more destructive periodontitis if not treated. As oral plaque is a key player in gingivitis, plaque control by professional scaling and oral hygiene measures represents the main line of treatment.
Among the oral hygiene measures, using chlorhexidine mouthwash is considered the gold standard in mouthwashes. However, due to its side effects, a safer and more acceptable mouthwash is needed. Therefore, this study proposes mouthwashes made of infusion of natural herbs as an alternative.
- Conditions
- Gingivitis
- Being tested
- Chlorhexidine 0,12%, herbal Mouthwash
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine 0,12%Drug
chlorhexidine 0.12% mouthwash twice daily for 7 days
herbal MouthwashDrug
Mouthwash made at home by boiling herbs in water and then saving the solution in a tightly closed container for daily use for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine mouthwash | Active comparator | Not described Receives: Drug: Chlorhexidine 0,12% |
| Herbal Homemade Mouthwash | Experimental | Not described Receives: Drug: herbal Mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
plaque index (O'Leary et al., 1972)
Plaque accumulation is tested on teeth with a probe. Number of sites having plaque accumulation will be divided by the total number of dental sites to get percentage of plaque accumulation.
Measured: 7 days
Secondary outcomes (4)
Bleeding on probing
Bleeding on probing is tested on teeth with a periodontal probe. Number of sites showing bleeding will be divided by the total number of dental sites to get percentage of bleeding on probing.
Measured: 7 days
Changes in clinical signs of inflammation (Armitage, 2004)
Results will be in the form of (Yes/No); indicating if the gingival clinical condition (color and contour) was improved or not
Measured: 7 days
Bleeding on brushing
Evaluation of extent of daily bleeding on brushing using VAS.
Measured: 7 days
Patient's acceptance of the mouthwash
questionnaire
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayat Gamal-AbdelNaser, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401069
- Sponsor's protocol ID
- ACU-Per3
- Status last verified
- Feb 2026
- First submitted
- 1 Feb 2026
- Last updated
- 10 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 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Homemade Herbal Mouthwash Versus Chlorhexidine on Plaque Accumulation in Gingivitis. A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT07401069
- Acronym / sponsor ID
- ACU-Per3
- Conditions
- Gingivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 10 Feb 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.
Gingivitis is a very common oral disease that may progress to the more destructive periodontitis if not treated. As oral plaque is a key player in gingivitis, plaque control by professional scaling and oral hygiene measures represents the main line of treatment.
Among the oral hygiene measures, using chlorhexidine mouthwash is considered the gold standard in mouthwashes. However, due to its side effects, a safer and more acceptable mouthwash is needed. Therefore, this study proposes mouthwashes made of infusion of natural herbs as an alternative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine mouthwash | Active comparator | Drug: Chlorhexidine 0,12% |
| Herbal Homemade Mouthwash | Experimental | Drug: herbal Mouthwash |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Plaque-induced gingivitis.
Key exclusion criteria (6 listed)
- Medically compromised.
- History of medications.
- Pregnant females.
- Periapical involvement in teeth.
- History of periodontal surgery.
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 0,12%chlorhexidine 0.12% mouthwash twice daily for 7 days | Drug | Chlorhexidine mouthwash |
| herbal MouthwashMouthwash made at home by boiling herbs in water and then saving the solution in a tightly closed container for daily use for 7 days | Drug | Herbal Homemade Mouthwash |
Primary outcome
plaque index (O'Leary et al., 1972)
Time frame: 7 days
Plaque accumulation is tested on teeth with a probe. Number of sites having plaque accumulation will be divided by the total number of dental sites to get percentage of plaque accumulation.
4 secondary outcomes
Bleeding on probing
Time frame: 7 days
Changes in clinical signs of inflammation (Armitage, 2004)
Time frame: 7 days
Bleeding on brushing
Time frame: 7 days
Patient's acceptance of the mouthwash
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chlorhexidine 0,12% and herbal Mouthwash in people with Gingivitis, run by Cairo University.
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 1 inclusion and 6 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: opening soon, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
plaque index (O'Leary et al., 1972) (time frame: 7 days). 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 10 Feb 2026.