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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Plaque Induced Gingival Disease
• Intervention / Treatment: Drug: Hyaluronic Acid mouthwash; Drug: Chlorohexidine 0.12% mouthwash

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.

Taste acceptance will be evaluated as the primary outcome using a validated facial hedonic scale following mouthwash use. Secondary outcomes will include changes in gingival inflammation and plaque accumulation, as measured by the Loe and Silness Gingival Index and the Silness and Loe Plaque Index, respectively.

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 Type: Interventional
• Enrollment (Estimated): 32
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yasmeen AS Abdelqader, Bachelors; Phone Number: +201018727929; Email: Yasmeen.saleh@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Egypt
    • Cairo, Egypt, Egypt, 11411
      • Faculty of dentistry, Cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hyaluronic acid mouthwah; 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; Q-Afta®, CIRA Pharma, Egypt
Active Comparator: Chlorohexidine 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; Hexitol®, 0.12% chlorhexidine gluconate; Arab Drug Company

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	After 14 days of mouthwash administeration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival index	Gingival health will be measured by Löe & Silness gingival index	At baseline before the study and after 14 days
Plaque index	Plaque index will be measured by Löe & Silness plaque index	At baseline before the study and after 14 days

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Ola M Omar, Professor, Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: June 18, 2026
• First Submitted That Met QC Criteria: June 18, 2026
• First Posted (Actual): June 23, 2026

Study Record Updates

• Last Update Posted (Actual): June 23, 2026
• Last Update Submitted That Met QC Criteria: June 18, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Children; Hyaluronic acid; gingivitis; Palatability; Chlorohexidine; Mouthwashe; Taste acceptance
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Gingivitis; Chemical Actions and Uses; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Specialty Uses of Chemicals; Cosmetics; Mouthwashes
• Other Study ID Numbers: Mouthwashes for children-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No