Efficacy Comparison of Three Approaches of Pharmacotherapy, Appliance Therapy and Psychotherapy on Sleep Bruxism Reduction of 6 to 12-year-old children

Efficacy Determination of three therapeutic approaches in schoolchildren with sleep bruxism

three arm parallel group randomized trial with blinded outcome assessment and data analysis

This study is being performed on 33 children aged 6 to 12 years old who have been referred to the Department of Pediatrics, Qazvin Faculty of Dentistry with complaint of sleep bruxism or have been identified during school examination. After providing explanations and obtaining consent, oral photography is prepared and oral symptoms of bruxism are examined. Pediatricians examine the patient in terms of parasitic infections, nutritional deficiencies, asthma and allergies, hormonal problems and blood disorders, and perform the necessary tests including CBC diff, Thyroid Function Test and Stool Exam. Prior to performing polysomnography, all dental infections are treated by a pediatric dentist. The frequency and intensity of sleep bruxism are recorded according to the parents report and the anxiety questionnaire is also obtained from the patient. Samples are randomly assigned to one of three treatment groups. The first group enters the psychotherapy course with a child psychologist for 3 months and the second group receives oral Lorazepam 5 mg/kg before bedtime (max dose of 2 mg) for 1 month. To the third group after impression taking, the hard night guard will be delivered for a period of three months. During the treatment, a telephone number will be provided to patients for answering questions and possible problems. At the end of the treatment, the outcome evaluator (blinded about the type of intervention) examining the intensity, frequency and extent of the parents' satisfaction with the treatment. The statistician is blind to the type of intervention and performs statistical analysis using ANOVA.

Inclusion criteria: 1) Complaint of tooth attrition or bruxism, 2) one of the following: dental facets- bruxism sounds for at least 3 nights in a week, jaw muscle soreness, 3) Both of these according to PSG: muscle activity during sleep, absence of comorbid seizure movements exclusion criteria: 1) severe malocclusions, 2) predisposing disease or conditions, 3) triggering dental condition or infections, 4) use of medicines with effect on sleep conditions (selective serotonin reuptake inhibitors, psychotropic, anti-depression, anti-anxiety, anticonvulsion, analgesic), 5) severe anxiety according to anxiety questionnaire

1- pharmacotherapy: Administration of Lorazepam 0.5 mg / kg body weight, at night before bedtime, for 1 month 2- appliance therapy: Hard night guard use for 3 months 3-psychotherapy: 10 sessions (3 months) of psychological therapy and relaxation training using the Benson model

Change in frequency and intensity of sleep bruxism

By simple lottery, the order of filling the intervention groups was determined and numbers of 1 to 3 assigned to each of the interventions. Each of the samples was assigned a number from 1 to 33. By random selection of the starting point in the table of random numbers, the movement in the horizontal or vertical path continued, the first number smaller than 33 as the first sample entered group one, followed by the other numbers less than 33. After capacity completion of the first group, groups two and three were completed in the same way.

Outcome evaluation will be implemented by an intervention-blind operator other than researcher and care taker, using randomized numbers for each sample. Results are delivered to statistician by numbers.