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

Investigating the effectiveness of total extracts of lactuca sativa seed (LSS) and Melissa officinalis leaves (MOL) on dental anxiety, heart rate and blood oxygen saturation percentage of patients

A clinical trial with a control group, double-blind, randomized by block randomization method, with a sample size of 48 patients, Split-mouth study

48 patients referred to the surgical department of the Faculty of Dentistry of Isfahan University of Medical Sciences are selected by considering the inclusion and exclusion criteria. After obtaining the patient's informed consent and demographic information, the Modified Dental Anxiety Scale for Dental Extraction Procedure (MDAS-DEP) is completed by the patient. The patient's heart rate and oxygen saturation percentage are measured using a pulse oximeter and recorded in the patient's initial questionnaire. Half an hour before the start of treatment, a capsule containing plant extract or placebo is given to the patient along with a glass of water. After the tooth extraction, the anxiety questionnaire is completed by the patient again, and the patient's heart rate and oxygen saturation percentage are measured again and recorded in the patient's secondary questionnaire.

Inclusion criteria: patients over 18 years of age, referred for extraction of non-impacted bilateral molar or premolar teeth. Non-inclusion criteria: pregnancy, lactation and using anxiolytic drugs and etc.

Half an hour before the start of treatment, one capsule containing 100 mg of total extract of LSS or one capsule containing 100 mg of total extract of MOL or one capsule containing 100 mg of corn starch as a placebo, depending on the study group, is given to the patient along with a glass of water.

Anxiety score, heart rate, blood oxygen saturation percentage

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.

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.