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

April 2, 2026 updated by: Sara usama kamal Ali elkholy, Cairo University

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt
        • Faculty of Dentistry Cairo University
        • Contact:
        • Principal Investigator:
          • Mahmoud Hamdy Eid, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants receive topical tannic acid mucoadhesive gel.
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)
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.
Experimental: Participants receive topical zinc acetate mucoadhesive gel
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)
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.
Active Comparator: Participants receive topical lidocaine gel
lidocaine gel applied intraorally prior to the dental procedure as a standard treatment comparator for gag reflex control
Drug: Lidocaine 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately after gel application during the dental procedure (single visit)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During the dental procedure (single visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Mahmoud Hamdy Eid, Professor, Faculty of Dentistry, Cairo University, Cairo, Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

March 28, 2026

First Submitted That Met QC Criteria

March 28, 2026

First Posted (Actual)

April 3, 2026

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gag reflex in children

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared to protect participant confidentiality and due to institutional policies.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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