Comparative study of the effect of three mucous adhesives containing lidocaine, zinc acetate and tannic acid on gag reflex in dental patients

Comparing the effect of three mucous adhesives containing lidocaine, zinc acetate and tannic acid on gag reflex in dental patients

The study is conducted as a controlled, randomized, double-blind clinical trial with a one-to-one descriptive ratio.the sampling is easy non-probability way. the samples will be assigned to 4 groups under study using the block random division method. A total of 228 samples will be included in this study.

The location of the project is in the radiology department of Kermanshah Faculty of Dentistry. There are 4 groups in this study. Each group contains 57 samples. In the first stage, people's gag reflex is measured using radiographic films. After 5 minutes of the first stage, 2 grams of mucous adhesives are placed in the distal teeth 7 and 8 in the soft and hard palate of the intervention groups for 10 to 15 minutes, then the gag reflex is evaluated again. This work is done by a doctor who, firstly, is unaware of the research hypothesis, and secondly, he is not aware of how people are assigned to intervention groups. Blind people in this study are researchers, participants and outcome assessors.

inclusion criteria : having a gag reflex when placing the radiology film in the mouth؛ Being over 18 years old and It is also having consent to enter the research. non-entry criteria: patients who had any central and peripheral nerve lesions, oral lesions, and a history of substance abuse.

In this study, there are 4 groups, each group is assigned a type of mucous adhesive. Intervention groups include: 1) Placebo 2) Mucosal adhesive containing 2% lidocaine 3) Mucosal adhesive containing 2% tannic acid 4) Mucosal adhesive containing 2% zinc acetate

The main result is the effect of the intervention on the gag reflex.

For randomization, given that we want the number of samples assigned to four groups to be the same at any time, the block random division method is used. For this purpose, first all four combinations are written, which includes 24 modes. Then, considering that the sample size in each group is 57, 57 times from this combination of four are selected by replacing the sample. For this, the binary sequence in the random number table is used. Binary combinations that are outside the range 01 to 24 are not considered.

The present study is conducted in a double-blind manner with a one-to-one allocation ratio. Blind people in this study are researchers, participants and outcome assessors. The study is conducted by a doctor (outcome assessor) who is firstly unaware of the research hypothesis and secondly is not aware of how people are assigned to intervention groups and the type of mucosal adhesive. The patient (participant) is also unaware of the research hypothesis and the type of mucosal adhesive, due to the same shape and color of the adhesives. The patient enters the study with his consent, but nothing is told to the patient regarding the decreasing or increasing effect of adhesives on the gag reflex. Also, the patient is unaware of the type of adhesive that is used for him.