Mucoadhesive Gels in Controlling Gag Reflex Among Children During Dental Radiographic Examination
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-10
SponsorCairo University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Tannic Acid Mucoadhesive Gel (Topical)
DrugA 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)
DrugA 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)
DrugA 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.
Treatment groups
66 Participants
are divided into 3 treatment groupsGroup A: Participants receive topical tannic acid mucoadhesive gel.Experimental treatment 1 intervention
Group B: Participants receive topical zinc acetate mucoadhesive gelExperimental treatment 1 intervention
Group C: Participants receive topical lidocaine gelActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Gag reflex severity score using a 5-point Likert faces scale
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.
Time frame
Immediately after gel application during the dental procedure (single visit)Secondary outcomes
1
Pulse rate (beats per minute)
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.
Time frame
During the dental procedure (single visit)Sponsors and contacts
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Source ClinicalTrials.gov
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