Gingivitis; ChronicPhase 3NCT07366398
Hyaluronic Acid Mouthwash as Adjunct
A Phase 3 study testing Hyaluoric acid mouthwash and Chlorhexidine 0,12% in people with Gingivitis; Chronic, run by Cairo University at 1 site in Egypt.
Trial summary
Patients were instructed to use 2 different mouthwashes after performing professional tooth cleaning. The effect of each of the 2 mouthwashes was detected. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Gingivitis; Chronic
- What is being tested?
- Hyaluoric acid mouthwash and Chlorhexidine 0,12%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to 30 May 2025
- Phase
- Phase 3
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with gingivitis
Who cannot join
- pregnant or lactating females and current smokers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hyaluronic Acid as Adjunctive to Chlorhexidine Mouthwash for Gingivitis: RCT
Patients were instructed to use 2 different mouthwashes after performing professional tooth cleaning. The effect of each of the 2 mouthwashes was detected.
Read the detailed description
The study tests the efficacy of hyaluronic acid (HYL) mouthwash as adjunct to Chlorhexidine (CHX) mouthwash compared to Chlorhexidine mouthwash only in 16 gingivitis patients. Patients were randomly assigned to either control group received (Chlorhexidine mouthwash) or test group received (hyaluronic acid + Chlorhexidine mouthwash). Clinical parameters and patient reported outcomes as post-operative questionnaire were assessed at baseline and seven days post-operatively.
- Conditions
- Gingivitis; Chronic
- Being tested
- Hyaluoric acid mouthwash, Chlorhexidine 0,12%
- Medical subject headings
- Gingivitis, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluoric acid mouthwashDrug
A mouthwash containing both hyaluronic acid
Chlorhexidine 0,12%Drug
mouthwash of chlorhexidine 0.12%
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine mouthwash | Active comparator | Not described Receives: Drug: Chlorhexidine 0,12% |
| Hyaluronic acid + Chlorhexidine mouthwash | Active comparator | Not described Receives: Drug: Hyaluoric acid mouthwash; Drug: Chlorhexidine 0,12% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding on probing
% of gingival sites where bleeding occurred on periodontal probing is registered out of total gingival sites
Measured: 7 days
Secondary outcomes (2)
Plaque index
% of gingival sites where plaque accumulates is registered out of total gingival sites
Measured: 7 days
Patient's satisfaction 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 posted26 Jan 2026
- Study start1 Feb 2025
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingivitis; ChronicStudies 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
- 16 participants (actual)
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
- NCT07366398
- Sponsor's protocol ID
- ACU-Per2
- Status last verified
- Jan 2026
- First submitted
- 17 Jan 2026
- Last updated
- 26 Jan 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 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyaluronic Acid as Adjunctive to Chlorhexidine Mouthwash for Gingivitis: RCT
- ClinicalTrials.gov ID
- NCT07366398
- Acronym / sponsor ID
- ACU-Per2
- Conditions
- Gingivitis; Chronic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 26 Jan 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.
Patients were instructed to use 2 different mouthwashes after performing professional tooth cleaning. The effect of each of the 2 mouthwashes was detected.
Detailed description
The study tests the efficacy of hyaluronic acid (HYL) mouthwash as adjunct to Chlorhexidine (CHX) mouthwash compared to Chlorhexidine mouthwash only in 16 gingivitis patients. Patients were randomly assigned to either control group received (Chlorhexidine mouthwash) or test group received (hyaluronic acid + Chlorhexidine mouthwash). Clinical parameters and patient reported outcomes as post-operative questionnaire were assessed at baseline and seven days post-operatively.
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% |
| Hyaluronic acid + Chlorhexidine mouthwash | Active comparator | Drug: Hyaluoric acid mouthwash, Drug: Chlorhexidine 0,12% |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed with gingivitis
Key exclusion criteria (1 listed)
- pregnant or lactating females and current smokers
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 |
|---|---|---|
| Hyaluoric acid mouthwashA mouthwash containing both hyaluronic acid | Drug | Hyaluronic acid + Chlorhexidine mouthwash |
| Chlorhexidine 0,12%mouthwash of chlorhexidine 0.12% | Drug | Chlorhexidine mouthwash, Hyaluronic acid + Chlorhexidine mouthwash |
Primary outcome
Bleeding on probing
Time frame: 7 days
% of gingival sites where bleeding occurred on periodontal probing is registered out of total gingival sites
2 secondary outcomes
Plaque index
Time frame: 7 days
Patient's satisfaction questionnaire
Time frame: 7 days
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 26 Jan 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. 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 Phase 3 study testing Hyaluoric acid mouthwash and Chlorhexidine 0,12% in people with Gingivitis; Chronic, run by Cairo University at 1 site in Egypt.
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 1 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 26 Jan 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 Egypt. 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.
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?
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?
Bleeding on probing (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 26 Jan 2026.