Plaque Induced Gingival DiseasePhase 1NCT07662226
Taste Acceptance and Effectiveness of Hyaluronic Acid and Chlorhexidine Mouthwashes in Children With Gingivitis
A Phase 1 study testing Hyaluronic Acid mouthwash and Chlorohexidine 0.12% mouthwash in people with Plaque Induced Gingival Disease, run by Cairo University at 1 site in Egypt.
Trial summary
This randomized controlled clinical trial aims to compare the taste acceptance and clinical effectiveness of hyaluronic mouthwash and chlorhexidine mouthwash in children with plaque-induced gingivitis. Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Plaque Induced Gingival Disease
- What is being tested?
- Hyaluronic Acid mouthwash and Chlorohexidine 0.12% mouthwash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2027to 1 Jul 2027
- Phase
- Phase 1
- 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 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged from 8-12 years of both sexes.
- Children with a history of bleeding on brushing typical signs and symptoms of gingivitis.
- Healthy child (ASA I).
- Eruption of upper and lower permanent central and lateral incisors.
- Parent's agreement to sign the informed consent.
- Parent's ability for attending follow up visits.
Who cannot join
- Children -allergic to Chlorhexidine or Hyaluronic acid.
- Children with special health care needs or having a history of serious systemic disease that may affect the gingival health.
- Use of Systemic NSAIDs, steroids, or antibiotics within a month before the study.
- Children undergoing orthodontic treatment or having an intra-oral prosthesis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Taste Acceptance and Clinical Effectiveness of Hyaluronic Acid Versus Chlorhexidine Mouthwashes in Children With Plaque-Induced Gingivitis: A Randomized Controlled Trial
This randomized controlled clinical trial aims to compare the taste acceptance and clinical effectiveness of hyaluronic mouthwash and chlorhexidine mouthwash in children with plaque-induced gingivitis. Clinical outcomes will be assessed using gingival and plaque indices, while taste acceptance will be evaluated using a validated hedonic scale. The findings may help identify a mouthwash that is both effective and acceptable to children, thereby improving adherence to oral hygiene practices.
Read the detailed description
This study is a randomized, single-blind, controlled clinical trial designed to compare the taste acceptance and clinical effectiveness of a hyaluronic acid mouthwash and a chlorhexidine mouthwash in children aged 8 to 10 years with plaque-induced gingivitis.
Eligible participants will be recruited from the outpatient clinic and screened according to the study eligibility criteria. After obtaining informed consent from parents or legal guardians and assent from the children, baseline clinical assessments will be performed. Gingival inflammation will be evaluated using the Loe and Silness Gingival Index, and dental plaque accumulation will be assessed using the Silness and Loe Plaque Index.
Participants will be randomly assigned in a 1:1 ratio to one of two intervention groups. The intervention group will receive a hyaluronic acid mouthwash, while the control group will receive a chlorhexidine mouthwash. Allocation concealment will be maintained using sealed opaque envelopes prepared by an independent investigator. Clinical outcome assessment will be performed by a blinded examiner who will remain unaware of group allocation throughout the study period.
All participants will receive standardized oral hygiene instructions and identical instructions regarding mouthwash use. Participants will be instructed to use the assigned mouthwash twice daily for 14 days in addition to their routine toothbrushing practices.
The Plaque Index will be evaluated as the primary outcome using the Silness and Löe Plaque Index. Secondary outcomes will include changes in gingival inflammation, as measured by the Löe and Silness Gingival Index, and taste acceptance, evaluated using a validated facial hedonic scale following mouthwash use.
Follow-up clinical examinations will be conducted after 14 days of intervention. Compliance with mouthwash use and any adverse events will be documented throughout the study period. The study aims to determine whether hyaluronic acid mouthwash provides comparable clinical effectiveness to chlorhexidine while demonstrating greater taste acceptance among children with plaque-induced gingivitis.
- Conditions
- Plaque Induced Gingival Disease
- Being tested
- Hyaluronic Acid mouthwash, Chlorohexidine 0.12% mouthwash
- Keywords
- gingivitis, Chlorohexidine, Hyaluronic acid, Mouthwashe, Children, Taste acceptance, Palatability
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic Acid mouthwashDrug
Q-Afta®, CIRA Pharma, Egypt
Chlorohexidine 0.12% mouthwashDrug
Hexitol®, 0.12% chlorhexidine gluconate; Arab Drug Company
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic acid mouthwah | Experimental | Participants in the experimental group will use a hyaluronic acid mouthwash (Q-Afta®, CIRA Pharma, Egypt). The principle investigator will instruct each participant to rinse with 10 mL of the mouthwash for 30-60 seconds twice daily after toothbrushing for a period of 14 days. And also not to swallow the mouthwash and to avoid eating or drinking for 30 minutes after rinsing Receives: Drug: Hyaluronic Acid mouthwash |
| Chlorohexidine mouthwash | Active comparator | Participants in the control group will use a chlorohexidine mouthwash (Hexitol). The principle investigator will instruct each participant to rinse with 10 mL of the mouthwash for 30-60 seconds twice daily after toothbrushing for a period of 14 day and not to swallow the mouthwash and to avoid eating or drinking for 30 minutes after rinsing. Receives: Drug: Chlorohexidine 0.12% mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque index
Plaque index will be measured by Löe \& Silness plaque index
Measured: At baseline before the study and after 14 days]
Secondary outcomes (2)
Gingival index
Gingival health will be measured by Löe \& Silness gingival index
Measured: At baseline before the study and after 14 days
Taste acceptance
Taste acceptance will be assessed using a visual analog scale (VAS) of faces, rated from 1 to 5, where 1 represents very bad taste, and 5 represents very good taste
Measured: After 14 days of mouthwash administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque Induced Gingival DiseaseStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmeen Abdullah Saleh Abdelqader, Cairo University
- Investigators
- Ola M Omar, Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07662226
- Sponsor's protocol ID
- Mouthwashes for children-2026
- Status last verified
- Oct 2026
- First submitted
- 18 Jun 2026
- Last updated
- 13 Oct 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 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taste Acceptance and Clinical Effectiveness of Hyaluronic Acid Versus Chlorhexidine Mouthwashes in Children With Plaque-Induced Gingivitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07662226
- Acronym / sponsor ID
- Mouthwashes for children-2026
- Conditions
- Plaque Induced Gingival Disease
- Keywords
- gingivitis, Chlorohexidine, Hyaluronic acid, Mouthwashe, Children, Taste acceptance, Palatability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 23 Jun 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 aims to compare the taste acceptance and clinical effectiveness of hyaluronic mouthwash and chlorhexidine mouthwash in children with plaque-induced gingivitis. Clinical outcomes will be assessed using gingival and plaque indices, while taste acceptance will be evaluated using a validated hedonic scale. The findings may help identify a mouthwash that is both effective and acceptable to children, thereby improving adherence to oral hygiene practices.
Detailed description
This study is a randomized, single-blind, controlled clinical trial designed to compare the taste acceptance and clinical effectiveness of a hyaluronic acid mouthwash and a chlorhexidine mouthwash in children aged 8 to 10 years with plaque-induced gingivitis.
Eligible participants will be recruited from the outpatient clinic and screened according to the study eligibility criteria. After obtaining informed consent from parents or legal guardians and assent from the children, baseline clinical assessments will be performed. Gingival inflammation will be evaluated using the Loe and Silness Gingival Index, and dental plaque accumulation will be assessed using the Silness and Loe Plaque Index.
Participants will be randomly assigned in a 1:1 ratio to one of two intervention groups. The intervention group will receive a hyaluronic acid mouthwash, while the control group will receive a chlorhexidine mouthwash. Allocation concealment will be maintained using sealed opaque envelopes prepared by an independent investigator. Clinical outcome assessment will be performed by a blinded examiner who will remain unaware of group allocation throughout the study period.
All participants will receive standardized oral hygiene instructions and identical instructions regarding mouthwash use. Participants will be instructed to use the assigned mouthwash twice daily for 14 days in addition to their routine toothbrushing practices.
The Plaque Index will be evaluated as the primary outcome using the Silness and Löe Plaque Index. Secondary outcomes will include changes in gingival inflammation, as measured by the Löe and Silness Gingival Index, and taste acceptance, evaluated using a validated facial hedonic scale following mouthwash use.
Follow-up clinical examinations will be conducted after 14 days of intervention. Compliance with mouthwash use and any adverse events will be documented throughout the study period. The study aims to determine whether hyaluronic acid mouthwash provides comparable clinical effectiveness to chlorhexidine while demonstrating greater taste acceptance among children with plaque-induced gingivitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic acid mouthwah | Experimental | Drug: Hyaluronic Acid mouthwashParticipants in the experimental group will use a hyaluronic acid mouthwash (Q-Afta®, CIRA Pharma, Egypt). The principle investigator will instruct each participant to rinse with 10 mL of the mouthwash for 30-60 seconds twice daily after toothbrushing for a period of 14 days. And also not to swallow the mouthwash and to avoid eating or drinking for 30 minutes after rinsing |
| Chlorohexidine mouthwash | Active comparator | Drug: Chlorohexidine 0.12% mouthwashParticipants in the control group will use a chlorohexidine mouthwash (Hexitol). The principle investigator will instruct each participant to rinse with 10 mL of the mouthwash for 30-60 seconds twice daily after toothbrushing for a period of 14 day and not to swallow the mouthwash and to avoid eating or drinking for 30 minutes after rinsing. |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children aged from 8-12 years of both sexes.
- Children with a history of bleeding on brushing typical signs and symptoms of gingivitis.
- Healthy child (ASA I).
- Eruption of upper and lower permanent central and lateral incisors.
- Parent's agreement to sign the informed consent.
Key exclusion criteria (4 listed)
- Children -allergic to Chlorhexidine or Hyaluronic acid.
- Children with special health care needs or having a history of serious systemic disease that may affect the gingival health.
- Use of Systemic NSAIDs, steroids, or antibiotics within a month before the study.
- Children undergoing orthodontic treatment or having an intra-oral prosthesis.
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 |
|---|---|---|
| Hyaluronic Acid mouthwashQ-Afta®, CIRA Pharma, Egypt | Drug | Hyaluronic acid mouthwah |
| Chlorohexidine 0.12% mouthwashHexitol®, 0.12% chlorhexidine gluconate; Arab Drug Company | Drug | Chlorohexidine mouthwash |
Primary outcome
Plaque index
Time frame: At baseline before the study and after 14 days]
Plaque index will be measured by Löe \& Silness plaque index
2 secondary outcomes
Gingival index
Time frame: At baseline before the study and after 14 days
Taste acceptance
Time frame: After 14 days of mouthwash administration
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 13 Oct 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.
Ola M Omar, Professor study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hyaluronic Acid mouthwash and Chlorohexidine 0.12% mouthwash in people with Plaque Induced Gingival Disease, 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 6 inclusion and 4 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 13 Oct 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Yasmeen AS Abdelqader, Bachelors (+201018727929, Yasmeen.saleh@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque index (time frame: At baseline before the study and after 14 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 13 Oct 2026.