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

Cairo University (CU)

Status: Begins enrollment in 4 months

Conditions: Gag Reflex in Children During Radiographic Dental Examination; Pediatric Dentistry

Treatments: Drug: Lidocaine Gel (Topical); Drug: Tannic Acid Mucoadhesive Gel (Topical); Drug: Zinc Acetate Mucoadhesive Gel (Topical)

Study type: Interventional

Funder types: Other

Identifiers

NCT07509918

Gag reflex in children

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 66 estimated patients

Sex: All

Ages: 8 to 10 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 3 patient groups

Participants receive topical tannic acid mucoadhesive gel.

Experimental group

Description:

tannic acid mucoadhesive gel applied intraorally prior to the dental procedure to evaluate its effectiveness in reducing gag reflex

Treatment:

Drug: Tannic Acid Mucoadhesive Gel (Topical)

Participants receive topical zinc acetate mucoadhesive gel

Experimental group

Description:

zinc acetate mucoadhesive gel applied intraorally prior to the dental procedure to assess its effect on gag reflex reduction.

Treatment:

Drug: Zinc Acetate Mucoadhesive Gel (Topical)

Participants receive topical lidocaine gel

Active Comparator group

Description:

lidocaine gel applied intraorally prior to the dental procedure as a standard treatment comparator for gag reflex control

Treatment:

Drug: Lidocaine Gel (Topical)