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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age8-10
SponsorCairo University

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hyaluronic Acid mouthwash

    Drug

    Q-Afta®, CIRA Pharma, Egypt

  • Chlorohexidine 0.12% mouthwash

    Drug

    Hexitol®, 0.12% chlorhexidine gluconate; Arab Drug Company

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Hyaluronic acid mouthwahExperimental treatment 1 intervention
Group B: Chlorohexidine mouthwashActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Plaque index

Plaque index will be measured by Löe \& Silness plaque index

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

Secondary outcomes

1

Gingival index

Gingival health will be measured by Löe \& Silness gingival index

Time frame
At baseline before the study and after 14 days
2

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

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: