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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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