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IRCT20221127056634N2 IRCT 2024-10-31 Esfahan University of Medical Sciences Investigating the effect of total extracts of Lactuca sativa seeds and Melissa officinalis leaves on dental anxiety Investigating the effect of total extracts of Lactuca sativa seeds and Melissa officinalis leaves on dental anxiety of patients referring for dental extraction; A Randomized Double-blind clinical trial 2024-10-31 anticipated 48 Complete https://irct.ir/trial/79755 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Random allocation of patients is done in two stages. In the first stage, patients are randomly assigned to one of the two treatment arms (lettuce seed or Melissa officinalis leave), and then in the second stage, two parts of each patient's mouth will be randomly assigned to drug and placebo treatment in each of the two treatment groups. Block randomization method is used with the aim of achieving groups of equal size in the first stage. The number of required blocks according to the total number of the estimated sample (48 patients) is 8 blocks, and the size of each block varies between 4,6 and 8. (2 blocks of 6, 3 blocks of 4 and 3 blocks of 8). In each block, according to the size specified for it, considering two treatment groups A (lettuce seeds), B (Melissa officinalis leaves), first all possible conditions are determined for the order of treatment allocation. For example, for blocks of size 4, the set of possible states for the order of allocation of the two desired treatments is considered including six orders AABB, ABAB, ABBA, BABA, BBAA and ABBA. Then by choosing one of the arrangements randomly from the set of all possible arrangements, the patients are allocated to two treatments A and B respectively. This pattern is repeated for other consecutive blocks as well until all the sample are randomly assigned to treatment groups. In the second stage, within each treatment group, the left and right parts of each patient's mouth (considering only one tooth in each part) were randomly selected by tossing a coin to one of the two treatment orders of the right tooth - drug treatment, left tooth - placebo (if the appearance heads) or left tooth - drug treatment, right tooth - placebo (if tails appears) are allocated, Blinding description: In order to blindness and not inform the patient about the received treatment, the capsules will have the same size and appearance, and the patient will not know the type of substance inside. Also, the statistician who analyzes the results will not know about the study groups of the patients. 3 Dental anxiety. Intervention 1: Intervention group A: Lettuce seed-placebo group: In one session, the patient receives a capsule containing 100 mg of spray-dried total extract powder of Lactuca Sativa seeds (obtained from Marwarid Gharb Khorasan Pharmaceutical Company). In the next session, when the patient comes to have his/her opposite tooth extracted, he/she receives a capsule containing 100 mg of corn starch as placebo. (or vice versa depending on randomization). Intervention 2: Intervention group B: Melissa officinalis leaves-placebo group: In one session, the patient receives a capsule containing 100 mg of spray-dried total extract powder of Melissa officinalis leaves (obtained from Marwarid Gharb Khorasan Pharmaceutical Company). In the next session, when the patient comes to have his/her opposite tooth extracted, he/she receives a capsule containing 100 mg of corn starch as placebo. (or vice versa depending on randomization). Intervention 3: Control group: As explained, each patient is placed in one session in the intervention group and one session in the control group. (split-mouth design). 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 Ali Mazdak
Isfahan University of Medical sciences, Hezarjerib st.
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 8138 alimazdak@res.mui.ac.ir Esfahan University of Medical Sciences scientific Mohammad Rabbani
Isfahan University of Medical sciences, Hezarjerib st.
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 8138 rabbani@pharm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients over 18 years old Patients referred for bilateral extraction of two molar or premolar teeth Having a healthy mental state and the ability and informed consent to complete the questionnaire 18 years no limit Both Taking CNS depressant and anxiolytic drugs such as benzodiazepines in the past fifteen days Pregnancy or lactation Continuous consumption of Sanabel Noma syrup or other lettuce seed products during the past month Continuous consumption of Nejabal capsule or other Melissa officinalis products during the last month History of allergy to lettuce or its seeds or Melissa officinalis Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group A: Lettuce seed-placebo group: In one session, the patient receives a capsule containing 100 mg of spray-dried total extract powder of Lactuca Sativa seeds (obtained from Marwarid Gharb Khorasan Pharmaceutical Company). In the next session, when the patient comes to have his/her opposite tooth extracted, he/she receives a capsule containing 100 mg of corn starch as placebo. (or vice versa depending on randomization) Intervention group B: Melissa officinalis leaves-placebo group: In one session, the patient receives a capsule containing 100 mg of spray-dried total extract powder of Melissa officinalis leaves (obtained from Marwarid Gharb Khorasan Pharmaceutical Company). In the next session, when the patient comes to have his/her opposite tooth extracted, he/she receives a capsule containing 100 mg of corn starch as placebo. (or vice versa depending on randomization) Control group: As explained, each patient is placed in one session in the intervention group and one session in the control group. (split-mouth design) Anxiety score in the questionnaire. Timepoint: Half an hour before the intervention (taking medicine), After the tooth extraction procedure. Method of measurement: Modified Dental Anxiety Scale for Dental Extraction Procedure questionnaire. Heart rate. Timepoint: Half an hour before the intervention (taking medicine), After the tooth extraction procedure. Method of measurement: Pulse oximeter device. Blood oxygen saturation percentage. Timepoint: Half an hour before the intervention (taking medicine), After the tooth extraction procedure. Method of measurement: Pulse oximeter device. Esfahan University of Medical Sciences Approved 2024-04-14 Research Ethics Committees of Schools of Pharmacy and Nutrition, Isfahan University of Medical Scien School of Pharmacy, Isfahan University of Medical Sciences, Hezar jerib st. Isfahan Isfehan Iran (Islamic Republic of)