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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During the dental procedure (single visit) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara Usama Elkholy, Dental degree | Contact | 01019603286 | Sara.osama@dentistry.cu.edu.eg | |
| Mohamed Atef Abdelhakim, Dental | Contact | 01154059058 | vertigo15.ma@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mahmoud Hamdy Eid, Professor | Faculty of Dentistry, Cairo University, Cairo, Egypt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of dentistry Cairo university | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26754182 | Background | 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. | |
| 39604959 | Background | Nikkerdar 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. |
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Individual participant data will not be shared to protect participant confidentiality and due to institutional policies.
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| ID | Term |
|---|---|
| D005683 | Gagging |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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. |
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| 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. |
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| 31721146 | Background | Eachempati 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. |
| 15153854 | Background | Bassi 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. |