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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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.
• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Gag reflex severity score using a 5-point Likert faces scale [Срок оценки: Immediately after gel application during the dental procedure (single visit)]

Вторичные конечные точки (1)

• Pulse rate (beats per minute) [Срок оценки: During the dental procedure (single visit)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Египет · 1 центр

• Faculty of dentistry Cairo university — Cairo

Публикации

• 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. PMID 26754182
• 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. PMID 39604959
• 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. PMID 31721146
• 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. PMID 15153854

Идентификаторы

NCT: NCT07509918 · Gag reflex in children

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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