Taste Acceptance and Effectiveness of Hyaluronic Acid and Chlorhexidine Mouthwashes in Children With Gingivitis

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.

• Hyaluronic Acid mouthwash (Drug): Q-Afta®, CIRA Pharma, Egypt
• Chlorohexidine 0.12% mouthwash (Drug): Hexitol®, 0.12% chlorhexidine gluconate; Arab Drug Company

Primary outcomes

• Plaque index [At baseline before the study and after 14 days]]: Plaque index will be measured by Löe \& Silness plaque index

Secondary outcomes

• Gingival index [At baseline before the study and after 14 days]: Gingival health will be measured by Löe \& Silness gingival index
• Taste acceptance [After 14 days of mouthwash administration]: 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

Sex: All, ages: 8 Years to 10 Years, accepts healthy volunteers

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

• Ola M Omar, Professor, Study director, Cairo University