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

NCT07509918 | Not Yet Recruiting

• 1 other identifier: Gag reflex in children
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Gag Reflex; Child

Keywords

Gag reflex; Radiographic dental examination; Pediatric dentistry; Mucoadhesive gels

Outcome Measures

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.

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

Secondary Outcomes (1)

• Pulse rate (beats per minute)

  During the dental procedure (single visit)

Study Arms (3)

Participants receive topical tannic acid mucoadhesive gel.

EXPERIMENTAL

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

Drug: Tannic Acid Mucoadhesive Gel (Topical)

Participants receive topical zinc acetate mucoadhesive gel

EXPERIMENTAL

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

Drug: Zinc Acetate Mucoadhesive Gel (Topical)

Participants receive topical lidocaine gel

ACTIVE COMPARATOR

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

Drug: Lidocaine Gel (Topical)

Interventions

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.

Participants receive topical tannic acid mucoadhesive gel.

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.

Participants receive topical zinc acetate mucoadhesive gel

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.

Participants receive topical lidocaine gel

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of dentistry Cairo university

Cairo, Egypt

Location

Related Publications (4)

• Elbay M, Tak O, Sermet Elbay Ü, et al. The use of low-level laser therapy for controlling the gag reflex in children during intraoral radiography. Lasers in Medical Science. 2016;31(2):355-361.

  BACKGROUND

• Nikkerdar N, Seyedi H, Mirzaeei S, et al. Comparative effects of three mucoadhesive gels containing lidocaine, zinc acetate, and tannic acid on the gag reflex of dental patients: a randomized double-blind clinical trial. BMC Oral Health. 2024;24:1442

  BACKGROUND

• Eachempati P, Kumbargere Nagraj S, Karanth L. Management of gag reflex for patients undergoing dental treatment. Cochrane Database of Systematic Reviews. 2019;(11):CD011116.

  BACKGROUND

• Bassi GS, Humphris GM, Longman LP. The etiology and management of gagging: a review of the literature. Journal of Prosthetic Dentistry. 2004;91(5):459-467.

  BACKGROUND

MeSH Terms

Conditions

Gagging

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mahmoud Hamdy Eid, Professor

  Faculty of Dentistry, Cairo University, Cairo, Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Usama Elkholy, Dental degree

CONTACT

01019603286; Sara.osama@dentistry.cu.edu.eg

Mohamed Atef Abdelhakim, Dental

CONTACT

01154059058; vertigo15.ma@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist

Study Record Dates

• First Submitted: March 28, 2026
• First Posted: April 3, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)