Clinical Efficacy of Three Mucoadhesive Gels in Controlling Gag Reflex Among Children Aged 8-10 Years During Radiographic Examination:A Randomized Pilot Clinical Trial
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Gag reflex severity score using a 5-point Likert faces scale
概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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
干预措施: Tannic Acid Mucoadhesive Gel (Topical) (Drug)
Participants receive topical lidocaine gel
lidocaine gel applied intraorally prior to the dental procedure as a standard treatment comparator for gag reflex control
干预措施: Lidocaine Gel (Topical) (Drug)
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.
干预措施: Zinc Acetate Mucoadhesive Gel (Topical) (Drug)
结局指标
主要结局
Gag reflex severity score using a 5-point Likert faces scale
时间窗: 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.
次要结局
- Pulse rate (beats per minute)(During the dental procedure (single visit))
研究者
Sara usama kamal Ali elkholy
Dentist
Cairo University