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NCT Number: NCT07509918

Mucoadhesive Gels in Controlling Gag Reflex Among Children During Dental Radiographic Examination

This randomized clinical trial compares tannic acid-zinc acetate mucoadhesive gel with lidocaine gel for reducing gag reflex in children aged 8-10 years during radiographic dental examination Gag reflex severity and pulse rate will be assessed before and after gel application. The study evaluates the effectiveness of the tested gel as a potential alternative to lidocaine.

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Key information

Age range

8 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of dentistry Cairo university

Cairo, Egypt

Location contact

Faculty Of Cairo university

CONTACT

[email protected]

01002159535

Mahmoud Hamdy Eid, Professor

PRINCIPAL_INVESTIGATOR

About this study

This randomized controlled clinical trial evaluates the effectiveness of a tannic acid-zinc acetate mucoadhesive gel compared to lidocaine gel in reducing gag reflex in children aged 8-10 years during dental procedures. Participants will be randomly assigned to receive either gel applied to the posterior palate before a standardized gag-inducing procedure. The primary outcome is the reduction in gag reflex severity using a validated scoring index. The secondary outcome is the change in pulse rate measured at baseline, after application, and during the procedure. This study aims to assess whether the tested mucoadhesive gel can provide an effective alternative to lidocaine with improved patient comfort.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The study will include children aged between 8 and 10 years .
  • Pediatric dental patients requiring intraoral radiographs for diagnostic or treatment purposes will be recruited.
  • Children present with a fully erupted maxillary last molar to allow standardized placement of the radiographic film for gag reflex stimulation.
  • Written informed consent will be obtained from parents or legal guardians before participation.

Exclusion criteria

  • Children with systemic diseases or neurological disorders that may influence gag reflex,such as epilepsy or cerebral palsy.
  • Those with a history of allergies to the materials that will be used in the study gels are not considered eligible.
  • Patients with acute respiratory infections, oropharyngeal inflammation, or enlarged tonsils at the time of the examination are excluded to avoid confounding variables.
  • Children taking medications known to modify gag reflex or pulse rate, such as sedatives or antihistamines, are not included.
  • Uncooperative or extremely anxious children, classified as Frankl ratings 1 or 2, are excluded

Treatment and study plan

Tannic Acid Mucoadhesive Gel (Topical)

Drug

A mucoadhesive gel containing tannic acid at a specified concentration is applied topically to the oral mucosa prior to the dental procedure. The gel is intended to reduce gag reflex through its astringent and protein-precipitating properties.

Zinc Acetate Mucoadhesive Gel (Topical)

Drug

A mucoadhesive gel containing zinc acetate at a specified concentration is applied topically to the oral mucosa before the dental procedure. The formulation is used to evaluate its potential effect in reducing gag reflex.

Lidocaine Gel (Topical)

Drug

A topical lidocaine gel at an appropriate concentration is applied to the oral mucosa prior to the dental procedure as a standard local anesthetic agent for gag reflex suppression.

Primary outcomes

  1. Gag reflex severity score using a 5-point Likert faces scale

    Time frame: Immediately after gel application during the dental procedure (single visit)

    Gag reflex severity is assessed using a 5-point Likert faces scale (score range: 0-5), where higher scores indicate greater gag reflex severity, following application of the assigned topical gel during the dental procedure.

Secondary outcomes

  1. Pulse rate (beats per minute)

    Time frame: During the dental procedure (single visit)

    Pulse rate is measured using a pulse oximeter and recorded in beats per minute (bpm) to assess physiological response during the dental procedure following application of the assigned topical gel.

Study contacts

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

Mohamed Atef Abdelhakim, Dental

CONTACT

[email protected]

01154059058

Sara Usama Elkholy, Dental degree

CONTACT

[email protected]

01019603286

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Clinical Efficacy of Three Mucoadhesive Gels in Controlling Gag Reflex Among Children Aged 8-10 Years During Radiographic Examination:A Randomized Pilot Clinical Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 3, 2026
Registry last updated
Apr 8, 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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