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NCT Number: NCT07662226

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

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.

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Key information

Age range

8 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Faculty of dentistry, Cairo university

Cairo, Egypt, 11411

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hyaluronic Acid mouthwash

Drug

Q-Afta®, CIRA Pharma, Egypt

Chlorohexidine 0.12% mouthwash

Drug

Hexitol®, 0.12% chlorhexidine gluconate; Arab Drug Company

Primary outcomes

  1. Taste acceptance

    Time frame: After 14 days of mouthwash administeration

    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

Secondary outcomes

  1. Gingival index

    Time frame: At baseline before the study and after 14 days

    Gingival health will be measured by Löe & Silness gingival index

  2. Plaque index

    Time frame: At baseline before the study and after 14 days

    Plaque index will be measured by Löe & Silness plaque index

Study contacts

Contact information is provided by the study sponsor or research team.

Yasmeen AS Abdelqader, Bachelors

CONTACT

[email protected]

+201018727929

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Taste Acceptance and Clinical Effectiveness of Hyaluronic Acid Versus Chlorhexidine Mouthwashes in Children With Plaque-Induced Gingivitis: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jun 23, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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