Ear Plugs Versus Acupressure for Management of Severe Gag Reflex: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change from baseline Gagging severity index score
研究概览
简要总结
The aim of this study is to evaluate the efficacy of two proposed non-invasive techniques: the ear plug technique and acupressure on the P6 point in reducing gag reflex during impression making and to assess patient's experience in terms of comfort and satisfaction.
详细描述
The study will take place at the clinics of Riyadh Colleges of Dentistry and Pharmacy (RCsDP) in Riyadh, Saudi Arabia.
Patients, who on previous occasions have demonstrated difficulties in accepting the procedure of making impressions of maxillary teeth due to a severe gag reflex (GR) will be invited to participate in the study.
A Randomized single blinded clinical trial will be conducted on 30 participants who fulfill the inclusion criteria. Participants will be assigned to three separate groups. For each patient, two maxillary alginate impressions will be made; one before applying the proposed management technique and one after. Participants of Group EP (n=10) will be managed using earplugs while Group AC (n=10) will be managed using acupressure band and Group PL (n=10) will receive placebo management in forms of regular bands.
Informed consent will be obtained from all participants. All impressions will be made by one dentist that will be blinded to the gag reflex (GR) management techniques. The GR evaluation for all the participants will be performed by another calibrated dentist who is also blinded to the applied technique.
The severity of gag reflex will be assessed during making of the first impression using Dickinson & Fiske (2005) gagging severity index (GSI).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The individual is able to give informed consent.
- •Patients with GR severity that are assigned to a gagging severity index (GSI) III-IV (for standardization of the baseline severity in between Groups).
排除标准
- •Pregnant women
- •Patients with Chronic heart diseases or cardiac pacemakers
- •Patients with central or peripheral nervous system disorders
- •Patients with oral lesions
- •Patients with gastrointestinal disorders.
研究组 & 干预措施
Earplugs
The participant will be asked to put plastic earplugs in both ears for 10 minutes and then the impression will be made while they are still on.
干预措施: Earplugs (Other)
Acupressure
The participant will be asked to wear sea bands on P6 points of both hand wrists for 10 minutes and then the impression will be made while they are still on.
干预措施: Acupressure (Other)
Placebo
The participant will be asked to wear non pressure bands on both hand wrists for 10 minutes and then the impression will be made while they are still on.
干预措施: Placebo (Other)
结局指标
主要结局
Change from baseline Gagging severity index score
时间窗: At the time of first impression which is made before applying the intervention method (baseline score) and again at the time of the second impression which is made after application of the intervention method by 10 minutes
Gagging severity index (GSI) is a scale of gagging severity which ranges from 1 to 5 (very mild to very severe)
次要结局
- Change from baseline Visual Analogue Scale scoring of patient's satisfaction during impression making(Directly after first impression which is made before applying the intervention (baseline score) and directly after the second impression which is made after application of the intervention method by 10 minutes)
研究者
Mohammad Ramadan Rayyan
Assistant professor
Riyadh Colleges of Dentistry and Pharmacy