Child, Gag Reflex
Conditions
Keywords
Gag reflex, Radiographic dental examination, Pediatric dentistry, Mucoadhesive gels
Brief summary
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.
Detailed 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.
Interventions
DRUGTannic Acid Mucoadhesive Gel (Topical)
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.
DRUGZinc Acetate Mucoadhesive Gel (Topical)
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.
DRUGLidocaine Gel (Topical)
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.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 10 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gag reflex severity score using a 5-point Likert faces scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Pulse rate (beats per minute) | 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. |
Countries
Egypt
Contacts
CONTACTSara Usama Elkholy, Dental degree
CONTACTMohamed Atef Abdelhakim, Dental
PRINCIPAL_INVESTIGATORMahmoud Hamdy Eid, Professor
Faculty of Dentistry, Cairo University, Cairo, Egypt
Outcome results
None listed