Gag ReflexNCT07509918
Mucoadhesive Gels in Controlling Gag Reflex Among Children During Dental Radiographic Examination
A study testing Tannic Acid Mucoadhesive Gel (Topical), Zinc Acetate Mucoadhesive Gel (Topical) and Lidocaine Gel (Topical) in people with Gag Reflex and Child, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Gag Reflex, Child
- What is being tested?
- Tannic Acid Mucoadhesive Gel (Topical), Zinc Acetate Mucoadhesive Gel (Topical) and Lidocaine Gel (Topical)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2026to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of dentistry Cairo university
Cairo
Faculty Of Cairo university, 01002159535, info@dentistry.cu.edu.eg
Mahmoud Hamdy Eid, Professor
About this study
Official title: 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.
Read the 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.
- Conditions
- Gag Reflex, Child
- Being tested
- Tannic Acid Mucoadhesive Gel (Topical), Zinc Acetate Mucoadhesive Gel (Topical), Lidocaine Gel (Topical)
- Keywords
- Gag reflex, Radiographic dental examination, Pediatric dentistry, Mucoadhesive gels
- Medical subject headings
- Gagging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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 Receives: Drug: Lidocaine Gel (Topical) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: During the dental procedure (single visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gag ReflexStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara usama kamal Ali elkholy, Cairo University
- Investigators
- Mahmoud Hamdy Eid, Professor, Principal investigator, Faculty of Dentistry, Cairo University, Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509918
- Sponsor's protocol ID
- Gag reflex in children
- Status last verified
- Mar 2026
- First submitted
- 28 Mar 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect participant confidentiality and due to institutional policies.
Publications
Elbay M, Tak O, Sermet Elbay U, Kaya C, Eryilmaz K. The use of low-level laser therapy for controlling the gag reflex in children during intraoral radiography. Lasers Med Sci. 2016 Feb;31(2):355-61. doi: 10.1007/s10103-016-1869-z. Epub 2016 Jan 11.
PubMed 26754182Nikkerdar N, Seyedi H, Mirzaeei S, Safari-Faramani R, Golshah A. 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 Nov 27;24(1):1442. doi: 10.1186/s12903-024-05248-9.
PubMed 39604959Eachempati P, Kumbargere Nagraj S, Kiran Kumar Krishanappa S, George RP, Soe HHK, Karanth L. Management of gag reflex for patients undergoing dental treatment. Cochrane Database Syst Rev. 2019 Nov 13;2019(11):CD011116. doi: 10.1002/14651858.CD011116.pub3.
PubMed 31721146Bassi GS, Humphris GM, Longman LP. The etiology and management of gagging: a review of the literature. J Prosthet Dent. 2004 May;91(5):459-67. doi: 10.1016/S0022391304000939.
PubMed 15153854
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Three Mucoadhesive Gels in Controlling Gag Reflex Among Children Aged 8-10 Years During Radiographic Examination:A Randomized Pilot Clinical Trial
- ClinicalTrials.gov ID
- NCT07509918
- Acronym / sponsor ID
- Gag reflex in children
- Conditions
- Gag Reflex, Child
- Keywords
- Gag reflex, Radiographic dental examination, Pediatric dentistry, Mucoadhesive gels
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Participants receive topical tannic acid mucoadhesive gel. | Experimental | Drug: Tannic Acid Mucoadhesive Gel (Topical)tannic acid mucoadhesive gel applied intraorally prior to the dental procedure to evaluate its effectiveness in reducing gag reflex |
| Participants receive topical zinc acetate mucoadhesive gel | Experimental | Drug: Zinc Acetate Mucoadhesive Gel (Topical)zinc acetate mucoadhesive gel applied intraorally prior to the dental procedure to assess its effect on gag reflex reduction. |
| Participants receive topical lidocaine gel | Active comparator | Drug: Lidocaine Gel (Topical)lidocaine gel applied intraorally prior to the dental procedure as a standard treatment comparator for gag reflex control |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Participants receive topical tannic acid mucoadhesive gel. |
| 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. | Drug | Participants receive topical zinc acetate mucoadhesive gel |
| 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. | Drug | Participants receive topical lidocaine gel |
Primary outcome
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.
1 secondary outcome
Pulse rate (beats per minute)
Time frame: During the dental procedure (single visit)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Background: PubMed 26754182Elbay M, Tak O, Sermet Elbay U, Kaya C, Eryilmaz K. The use of low-level laser therapy for controlling the gag reflex in children during intraoral radiography. Lasers Med Sci. 2016 Feb;31(2):355-61. doi: 10.1007/s10103-016-1869-z. Epub 2016 Jan 11.
- Background: PubMed 39604959Nikkerdar N, Seyedi H, Mirzaeei S, Safari-Faramani R, Golshah A. 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 Nov 27;24(1):1442. doi: 10.1186/s12903-024-05248-9.
- Background: PubMed 31721146Eachempati P, Kumbargere Nagraj S, Kiran Kumar Krishanappa S, George RP, Soe HHK, Karanth L. Management of gag reflex for patients undergoing dental treatment. Cochrane Database Syst Rev. 2019 Nov 13;2019(11):CD011116. doi: 10.1002/14651858.CD011116.pub3.
- Background: PubMed 15153854Bassi GS, Humphris GM, Longman LP. The etiology and management of gagging: a review of the literature. J Prosthet Dent. 2004 May;91(5):459-67. doi: 10.1016/S0022391304000939.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect participant confidentiality and due to institutional policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mahmoud Hamdy Eid, Professor principal investigator
Faculty of Dentistry, Cairo University, Cairo, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tannic Acid Mucoadhesive Gel (Topical), Zinc Acetate Mucoadhesive Gel (Topical) and Lidocaine Gel (Topical) in people with Gag Reflex and Child, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Usama Elkholy, Dental degree (01019603286, Sara.osama@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gag reflex severity score using a 5-point Likert faces scale (time frame: Immediately after gel application during the dental procedure (single visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07509918, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.