NCT07662226

Brief 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. 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
9mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 23, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

June 23, 2026

Status Verified

June 1, 2026

Enrollment Period

4 months

First QC Date

June 18, 2026

Last Update Submit

June 18, 2026

Conditions

Plaque Induced Gingival Disease

Keywords

gingivitisChlorohexidineHyaluronic acidMouthwasheChildrenTaste acceptancePalatability

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Gingival index

    At baseline before the study and after 14 days

  • Plaque index

    At baseline before the study and after 14 days

Study Arms (2)

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

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.

Drug: Chlorohexidine 0.12% mouthwash

Interventions

Hyaluronic Acid mouthwashDRUG

Q-Afta®, CIRA Pharma, Egypt

Hyaluronic acid mouthwah
Chlorohexidine 0.12% mouthwashDRUG

Hexitol®, 0.12% chlorhexidine gluconate; Arab Drug Company

Chlorohexidine mouthwash

Eligibility Criteria

Age8 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry, Cairo university

Cairo, Egypt, 11411, Egypt

Location

MeSH Terms

Conditions

Gingivitis

Interventions

Mouthwashes

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biomedical and Dental MaterialsSpecialty Uses of ChemicalsChemical Actions and UsesCosmeticsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Ola M Omar, Professor

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Yasmeen AS Abdelqader, Bachelors

CONTACT

+201018727929Yasmeen.saleh@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Blinding of trial's principal investigator will not be possible due to evident differences between the two mouthwashes. The statistician responsible for data analysis will remain blinded to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 18, 2026

First Posted

June 23, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

June 23, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)