A Phase 1 interventional study of Hyaluronic Acid mouthwash and Chlorohexidine 0.12% mouthwash in Plaque Induced Gingival Disease, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to participants aged 8 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Cairo University · Phase 1, Interventional, and Treatment
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.
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.
631 studies on the registry are indexed under Gingivitis; 107 are open to participants now.
This study's planned enrollment of 24 is below the median of 66 across 507 interventional studies indexed under Gingivitis.
Browse Gingivitis studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: Hyaluronic Acid mouthwash
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.
Drug: Chlorohexidine 0.12% mouthwash
Q-Afta®, CIRA Pharma, Egypt
Hexitol®, 0.12% chlorhexidine gluconate; Arab Drug Company
Plaque index
Plaque index will be measured by Löe \& Silness plaque index
Time frame: At baseline before the study and after 14 days]
Gingival index
Gingival health will be measured by Löe \& Silness gingival index
Time frame: 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
Time frame: After 14 days of mouthwash administration
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Hyaluronic Acid