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IRCT20230418057951N1 IRCT 2023-04-30 Tabriz University of Medical Sciences The effect of oral hygiene education in adolescents with bipolar mood disorder The effect of Cognitive Behavioral Therapy on the dental plaque index of adolescents with bipolar mood disorder 2023-04-25 anticipated 60 Complete https://irct.ir/trial/69709 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Random sampling will be done among the children and adolescents referred to Tabriz Razi Hospital or from the child and adolescent psychiatry clinics of Tabriz University of Medical Sciences who are eligible for the study. The randomization method is simple and its unit is individual. Our tool for randomizing a table of random numbers. Based on this, the type of treatment is marked with code A (oral health education with cognitive-behavioral therapy technique) and B (control) and placed inside the sealed envelopes. Then the envelopes are placed in a bag and mixed. Then it is randomly selected from the bag and treatment is given to the patient by observing the code. The researcher who has to enter the data into the checklist will not know the type of group the person is in, Blinding description: This study is single blind. The researcher who has to enter the data into the checklist will not know about the type of group that the person is in. N/A Dental plaque. Intervention 1: Intervention group: People will be examined by a dentist and training on the dentic will be shown in a practical way, and participants will practice the taught materials on dentistry. Then, the disclosing solution is contacted with all the dental surfaces for 30 seconds, and after washing the mouth, it is checked using a mirror and probe under the light of the unit, and the number of colored surfaces is calculated in relation to the total dental surfaces, and the index plate is obtained. A week after the training session on the dentic, people will be called again and examined by a dentist, and their dental plaque index will be evaluated and recorded, and health education will be repeated if needed. Then the participants will be randomly divided into case and control groups. People in the intervention group will participate in 8 in-person oral hygiene training sessions with cognitive-behavioral therapy techniques. At the end of each session, assignments are given to these people and will be reviewed at the beginning of the next session. One month after the sessions, they will be examined by a dentist who is unaware of the groupings, and their index plates will be recorded and evaluated. Intervention 2: Control group: People will be examined by a dentist and training on the dentic will be shown in a practical way, and participants will practice the taught materials on dentistry. Then, the disclosing solution is contacted with all the dental surfaces for 30 seconds, and after washing the mouth, it is checked using a mirror and probe under the light of the unit, and the number of colored surfaces is calculated in relation to the total dental surfaces, and the index plate is obtained. A week after the training session on the dentic, people will be called again and examined by a dentist, and their dental plaque index will be evaluated and recorded, and health education will be repeated if needed. Then the participants will be randomly divided into case and control groups. The people of the control group will be called one month later and their index plates will be evaluated and recorded. 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 Neda Yasmineh
Tabriz University of Medical Sciences, Golgasht St.
Tabriz Iran (Islamic Republic of) 5166614711 +98 44 3344 4598 yasamineh@gmail.com Tabriz University of Medical Sciences scientific Neda Yasmineh
Tabriz University of Medical Sciences, Golgasht St
Tabriz Iran (Islamic Republic of) 5166614711 +98 44 3344 4598 yasamineh@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Adolescents aged 12 to 18 with bipolar disorder Having written informed consent from the parent or legal guardian (consent) and oral consent from the participating adolescent (oral assent) 12 years 18 years Both Suffering from major psychiatric and other physical diseases Presence of congenital genetic disorder Use of anticholinergic drugs K02 Dental caries Other Treatment - Other Intervention group: People will be examined by a dentist and training on the dentic will be shown in a practical way, and participants will practice the taught materials on dentistry. Then, the disclosing solution is contacted with all the dental surfaces for 30 seconds, and after washing the mouth, it is checked using a mirror and probe under the light of the unit, and the number of colored surfaces is calculated in relation to the total dental surfaces, and the index plate is obtained. A week after the training session on the dentic, people will be called again and examined by a dentist, and their dental plaque index will be evaluated and recorded, and health education will be repeated if needed. Then the participants will be randomly divided into case and control groups. People in the intervention group will participate in 8 in-person oral hygiene training sessions with cognitive-behavioral therapy techniques. At the end of each session, assignments are given to these people and will be reviewed at the beginning of the next session. One month after the sessions, they will be examined by a dentist who is unaware of the groupings, and their index plates will be recorded and evaluated. Control group: People will be examined by a dentist and training on the dentic will be shown in a practical way, and participants will practice the taught materials on dentistry. Then, the disclosing solution is contacted with all the dental surfaces for 30 seconds, and after washing the mouth, it is checked using a mirror and probe under the light of the unit, and the number of colored surfaces is calculated in relation to the total dental surfaces, and the index plate is obtained. A week after the training session on the dentic, people will be called again and examined by a dentist, and their dental plaque index will be evaluated and recorded, and health education will be repeated if needed. Then the participants will be randomly divided into case and control groups. The people of the control group will be called one month later and their index plates will be evaluated and recorded. Dental Plaque. Timepoint: One month after the end of the sessions. Method of measurement: People will be examined by a dentist and training on dentistry will be shown in a practical way, and participants will practice the taught materials on dentistry. Then, the disclosing solution is contacted with all the dental surfaces for 30 seconds, and after washing the mouth, it is checked using a mirror and probe under the light of the unit, and the number of colored surfaces is calculated in relation to the total dental surfaces, and the index plate is obtained. Tabriz University of Medical Sciences Approved 2023-03-06 Ethics committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Golgasht St. Tabriz East Azarbaijan Iran (Islamic Republic of)