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IRCT20220211053997N1 IRCT 2022-12-19 Kermanshah University of Medical Sciences Effect of lidocaine, zinc acetate and tannic acid on gag reflex Comparative study of the effect of three mucous adhesives containing lidocaine, zinc acetate and tannic acid on gag reflex in dental patients 2023-01-21 anticipated 228 Complete https://irct.ir/trial/61954 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: 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, Blinding description: 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. 3 Gag reflex. Intervention 1: Intervention group1: The receiving group of mucous adhesive containing 2% lidocaine. There are 57 samples in this group. Hydroxypropyl Methyl Cellulose (HPMC), Polyvinyl chloride (PVC) and Hydroxyethyl cellulose (HEC) polymers are used as the base of the mucous adhesive to make adhesives. Then 2% active ingredients are added to the base of mucous adhesives. The dosage is 2gram per use. It is used once for each sample.Placebo is placed in the form of oral adhesive by means of a swap in the distal teeth 7 and 8 on the upper right or left on the soft and hard palate for 5-10 minutes and then the gag reflex is measured.The polymers used are made by germany's merck company.These adhesive gels are checked in terms of basic specifications. The physicochemical characteristics of the adhesive gels are checked. The microbial control test is performed on the adhesive gels. The viscosity and Ph tests are performed on the adhesive gels. These adhesives do not have any harm to patients. All the materials and bases used in these adhesive mucus formulations are approved by the Food and Drug Administration (FDA) and are of a pharmaceutical grade that is not toxic to humans. Reference: American Pharmacopoeia (USP). Intervention 2: Intervention group2: The receiving group of mucous adhesive containing zinc acetate 2%. There are 57 samples in this group. Hydroxypropyl Methyl Cellulose (HPMC), Polyvinyl chloride (PVC) and Hydroxyethyl cellulose (HEC) polymers are used as the base of the mucous adhesive to make adhesives. Then 2% active ingredients are added to the base of mucous adhesives. The dosage is 2gram per use. It is used once for each sample.Placebo is placed in the form of oral adhesive by means of a swap in the distal teeth 7 and 8 on the upper right or left on the soft and hard palate for 5-10 minutes and then the gag reflex is measured.The polymers used are made by germany's merck company.These adhesive gels are checked in terms of basic specifications. The physicochemical characteristics of the adhesive gels are checked. The microbial control test is performed on the adhesive gels. The viscosity and Ph tests are performed on the adhesive gels. These adhesives do not have any harm to patients. All the materials and bases used in these adhesive mucus formulations are approved by the Food and Drug Administration (FDA) and are of a pharmaceutical grade that is not toxic to humans. Reference: American Pharmacopoeia (USP). Intervention 3: Intervention group3: The receiving group of mucous adhesive containing 2% tannic acid. There are 57 samples in this group. Hydroxypropyl Methyl Cellulose (HPMC), Polyvinyl chloride (PVC) and Hydroxyethyl cellulose (HEC) polymers are used as the base of the mucous adhesive to make adhesives. Then 2% active ingredients are added to the base of mucous adhesives. The dosage is 2gram per use. It is used once for each sample.Placebo is placed in the form of oral adhesive by means of a swap in the distal teeth 7 and 8 on the upper right or left on the soft and hard palate for 5-10 minutes and then the gag reflex is measured.The polymers used are made by germany's merck company.These adhesive gels are checked in terms of basic specifications. The physicochemical characteristics of the adhesive gels are checked. The microbial control test is performed on the adhesive gels. The viscosity and Ph tests are performed on the adhesive gels. These adhesives do not have any harm to patients. All the materials and bases used in these adhesive mucus formulations are approved by the Food and Drug Administration (FDA) and are of a pharmaceutical grade that is not toxic to humans. Reference: American Pharmacopoeia (USP). Intervention 4: Control group: People receive placebo. 57 samples participate in this group. Hydroxypropyl Methyl Cellulose (HPMC), Polyvinyl chloride (PVC) and Hydroxyethyl cellulose (HEC) polymers are used as the base of the mucous adhesive to make adhesives. The dosage is 2gram per use. It is used once for each sample.Placebo is placed in the form of oral adhesive by means of a swap in the distal teeth 7 and 8 on the upper right or left on the soft and hard palate for 5-10 minutes and then the gag reflex is measured.The polymers used are made by germany's merck company. These adhesive gels are checked in terms of basic specifications. The physicochemical characteristics of the adhesive gels are checked. The microbial control test is performed on the adhesive gels. The viscosity and Ph tests are performed on the adhesive gels. These adhesives do not have any harm to patients. All the materials and bases used in these adhesive mucus formulations are approved by the Food and Drug Administration (FDA), and are of a pharmaceutical grade that is not toxic to humans. Reference: American Pharmacopoeia (USP). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Hosna Seyedi
Faculty of Dentistry, in front of the post office, above Shora St., Dr. Shariati St.
Kermanshah Iran (Islamic Republic of) 6713954658 +98 83 3729 6591 hosna.seyedi@kums.ac.ir Kermanshah University of Medical Sciences scientific Hosna Seyedi
Faculty of Dentistry, in front of the post office, above Shora St., Dr. Shariati St.
Kermanshah Iran (Islamic Republic of) 6713954658 +98 83 3727 7030 hosna.seyedi@kums.ac.ir Kermanshah University of Medical Sciences Iran (Islamic Republic of) Having a gag reflex when placing the radiology film in the mouth Be over 18 years old Having consent to enter the research 18 years no limit Both Patients who have any central and peripheral nerve damage Patients with any oral lesions Patients with a history of substance abuse Prevention Prevention Prevention Prevention Intervention group1: The receiving group of mucous adhesive containing 2% lidocaine. There are 57 samples in this group. Hydroxypropyl Methyl Cellulose (HPMC), Polyvinyl chloride (PVC) and Hydroxyethyl cellulose (HEC) polymers are used as the base of the mucous adhesive to make adhesives. Then 2% active ingredients are added to the base of mucous adhesives. The dosage is 2gram per use. It is used once for each sample.Placebo is placed in the form of oral adhesive by means of a swap in the distal teeth 7 and 8 on the upper right or left on the soft and hard palate for 5-10 minutes and then the gag reflex is measured.The polymers used are made by germany's merck company.These adhesive gels are checked in terms of basic specifications. The physicochemical characteristics of the adhesive gels are checked. The microbial control test is performed on the adhesive gels. The viscosity and Ph tests are performed on the adhesive gels. These adhesives do not have any harm to patients. All the materials and bases used in these adhesive mucus formulations are approved by the Food and Drug Administration (FDA) and are of a pharmaceutical grade that is not toxic to humans. Reference: American Pharmacopoeia (USP) Intervention group2: The receiving group of mucous adhesive containing zinc acetate 2%. There are 57 samples in this group. Hydroxypropyl Methyl Cellulose (HPMC), Polyvinyl chloride (PVC) and Hydroxyethyl cellulose (HEC) polymers are used as the base of the mucous adhesive to make adhesives. Then 2% active ingredients are added to the base of mucous adhesives. The dosage is 2gram per use. It is used once for each sample.Placebo is placed in the form of oral adhesive by means of a swap in the distal teeth 7 and 8 on the upper right or left on the soft and hard palate for 5-10 minutes and then the gag reflex is measured.The polymers used are made by germany's merck company.These adhesive gels are checked in terms of basic specifications. The physicochemical characteristics of the adhesive gels are checked. The microbial control test is performed on the adhesive gels. The viscosity and Ph tests are performed on the adhesive gels. These adhesives do not have any harm to patients. All the materials and bases used in these adhesive mucus formulations are approved by the Food and Drug Administration (FDA) and are of a pharmaceutical grade that is not toxic to humans. Reference: American Pharmacopoeia (USP) Intervention group3: The receiving group of mucous adhesive containing 2% tannic acid. There are 57 samples in this group. Hydroxypropyl Methyl Cellulose (HPMC), Polyvinyl chloride (PVC) and Hydroxyethyl cellulose (HEC) polymers are used as the base of the mucous adhesive to make adhesives. Then 2% active ingredients are added to the base of mucous adhesives. The dosage is 2gram per use. It is used once for each sample.Placebo is placed in the form of oral adhesive by means of a swap in the distal teeth 7 and 8 on the upper right or left on the soft and hard palate for 5-10 minutes and then the gag reflex is measured.The polymers used are made by germany's merck company.These adhesive gels are checked in terms of basic specifications. The physicochemical characteristics of the adhesive gels are checked. The microbial control test is performed on the adhesive gels. The viscosity and Ph tests are performed on the adhesive gels. These adhesives do not have any harm to patients. All the materials and bases used in these adhesive mucus formulations are approved by the Food and Drug Administration (FDA) and are of a pharmaceutical grade that is not toxic to humans. Reference: American Pharmacopoeia (USP) Control group: People receive placebo. 57 samples participate in this group. Hydroxypropyl Methyl Cellulose (HPMC), Polyvinyl chloride (PVC) and Hydroxyethyl cellulose (HEC) polymers are used as the base of the mucous adhesive to make adhesives. The dosage is 2gram per use. It is used once for each sample.Placebo is placed in the form of oral adhesive by means of a swap in the distal teeth 7 and 8 on the upper right or left on the soft and hard palate for 5-10 minutes and then the gag reflex is measured.The polymers used are made by germany's merck company. These adhesive gels are checked in terms of basic specifications. The physicochemical characteristics of the adhesive gels are checked. The microbial control test is performed on the adhesive gels. The viscosity and Ph tests are performed on the adhesive gels. These adhesives do not have any harm to patients. All the materials and bases used in these adhesive mucus formulations are approved by the Food and Drug Administration (FDA), and are of a pharmaceutical grade that is not toxic to humans. Reference: American Pharmacopoeia (USP) The degree of gag reflex of all participant samples is based on a self-reported scale by placing intraoral radiology film in their mouths. Timepoint: In the first step, the degree of gag reflex of all samples is recorded.5 minutes after the first stage, in the second stage, after 5-10 minutes of adhesive intervention, the gag reflex is measured using the same scale. Method of measurement: How to score the intensity of the gag reflex by the patient and with the help of a visual analog scale (absence of gag reflex, zero, very weak gag reflex, number 1, weak gag reflex, number 2, moderate gag reflex, number 3, severe gag reflex, number 4, and the most severe reflex, number 5) is done. Kermanshah University of Medical Sciences Approved 2022-12-11 Ethics committee of Kermanshah University of Medical Sciences 2nd floor, Hoor Building, 236 Alley, Pamchal Ave, Pardis Town Kermanshah Kermanshah Iran (Islamic Republic of)