]>
IRCT20140624018214N2 IRCT 2018-11-29 Tehran University of Medical Sciences Comparison of the effectiveness of different methods of oral health education for the visually impaired students Comparison of the effectiveness of oral health education using Audio Tactile Performance (ATP) technique alone; ATP combined with oral health education for parents; ATP and art package, on oral health status of students with visual impairment 2018-12-01 anticipated 200 Complete https://irct.ir/trial/34676 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple randomization is done by Excel software. Each class is considered to be a cluster in each school. Stratification is then done in each school for clusters, and it creates 2 layers: fifth grade and lower; sixth grade and higher. Within the layers, for each cluster, as well as for each of the three study groups, a code is considered and recorded. For example, the first cluster will be coded as "QWZ" and control group as "GFD" . For each school, all codes will be entered into Excel software in two columns; a column for clusters; another column for study groups. A colleague who is not informed about the coding process, will be asked to run the randomization command in Excel for these two columns. Thus, each cluster will be randomly entered into one of the three study groups (control; the first intervention ; the second intervention), Blinding description: The post-intervention examination will be done by the second calibrated examiner, who is not present in the oral health education (intervention) and the allocation of groups. 2. The data will be entered to the SPSS with special codes so that the analyst will be blind about the clusters and groups. Latin letters will be chosen by chance, for the first cluster, for example, "asd" , and for control group, "cbn". After finishing the data analysis, these codes will be renamed to the original names of the groups and clusters. N/A Condition 1: Gingivitis and periodontal diseases. Condition 2: Dental caries. Intervention 1: The first intervention group (ATP and parents): The parents' questionnaire will be completed by telephone. Then, training is provided to parents to raise their awareness of oral health.These educations include the importance of oral hygiene to prevent caries and gum disease, the role of fluoride in controlling caries, the necessity to control the consumption of sugar and the importance of regular dental visits. The parents will then be asked to brush twice daily for two minutes and encourage their child to do this, too. Oral health education by ATP (Audio Tactile Performance) technique will be delivered to the students in class. In this technique, a verbal oral health Education will be delivered on the importance of teeth, oral hygiene, proper brushing, dental floss, fluoride, and the importance of controlling the consumption of sugar, in accordance with the age of the students. Then, the proper brushing technique will be taught individually by intra-oral guidance of the student's hand with the students' own toothbrush, until it is ensured that the student can properly handle it. one week and two weeks after the beginning of the intervention, the intervention will be repeated.Post-intervention examination will be done one month and two months after the beginning of the intervention. Intervention 2: The second intervention group (ATP and art package): In this group, in addition to ATP technique, educational dental cast, game-based education and music-based education will be used. Normal and common pathological conditions of the teeth and gingiva will be simulated on dental cast. The students will be asked to move their fingers over casts to distinguish the cavitated dental caries, calculus and gingival swelling. Using play dough to make hand craft about oral health, will be considered as a game-based education. Music-based education also will be used. A music is prepared which focuses on the direction of tooth brushing for each jaw, side and surface with equal time to give equal importance to all surfaces. The music will be played in the class and students will perform the tooth brushing; listening to the music until they get able to brush properly.This music will be given to them to use at home every day. One week and two weeks after the beginning of the intervention, the intervention will be repeated.The post intervention examination will be done one month and two months after the beginning of the intervention.To prevent the contamination between the second group (ATP and art package) with other groups, interventions for the second group (ATP and art package) will be performed after the intervention of the other two groups. Intervention 3: The control group (ATP) :Oral health education by ATP (Audio Tactile Performance) technique will be delivered to the students. A verbal oral health education will be delivered on the importance of teeth, oral hygiene, proper brushing, dental floss, fluoride, and the importance of controlling the consumption of sugar, in accordance with the age of the students. Then, the proper brushing technique will be taught individually by intra-oral guidance of the student's hand with the students' own toothbrush, until it is ensured that the student can properly handle it. one week and two weeks after the beginning of the intervention, the intervention will be repeated.Post-intervention examination will be done one month and two months after the beginning of the intervention. 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 No additional data
public Nasrin Sharififard
Department of Community Oral Health, School of Dentistry, Tehran University of Medical Sciences, North Kargar Ave, Tehran
Tehran Iran (Islamic Republic of) 1439955991 +98 21 8801 5960 nsharififard@razi.tums.ac.ir Tehran University of Medical Sciences scientific Katayoun Sargeran
Department of Community Oral Health, School of Dentistry, Tehran University of Medical Sciences, North Kargar Ave, Tehran
Tehran Iran (Islamic Republic of) 1439955991 +98 21 8801 5960 k-sargeran@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Students in preschool to 10th grade in schools for blinds in Tehran The student and parent's consent for participation in the study 6 years 17 years Both Mentally disabled students Physically disabled students K05 K02 Gingivitis and periodontal diseases Dental caries Prevention Prevention Prevention The first intervention group (ATP and parents): The parents' questionnaire will be completed by telephone. Then, training is provided to parents to raise their awareness of oral health.These educations include the importance of oral hygiene to prevent caries and gum disease, the role of fluoride in controlling caries, the necessity to control the consumption of sugar and the importance of regular dental visits. The parents will then be asked to brush twice daily for two minutes and encourage their child to do this, too. Oral health education by ATP (Audio Tactile Performance) technique will be delivered to the students in class. In this technique, a verbal oral health Education will be delivered on the importance of teeth, oral hygiene, proper brushing, dental floss, fluoride, and the importance of controlling the consumption of sugar, in accordance with the age of the students. Then, the proper brushing technique will be taught individually by intra-oral guidance of the student's hand with the students' own toothbrush, until it is ensured that the student can properly handle it. one week and two weeks after the beginning of the intervention, the intervention will be repeated.Post-intervention examination will be done one month and two months after the beginning of the intervention. The second intervention group (ATP and art package): In this group, in addition to ATP technique, educational dental cast, game-based education and music-based education will be used. Normal and common pathological conditions of the teeth and gingiva will be simulated on dental cast. The students will be asked to move their fingers over casts to distinguish the cavitated dental caries, calculus and gingival swelling. Using play dough to make hand craft about oral health, will be considered as a game-based education. Music-based education also will be used. A music is prepared which focuses on the direction of tooth brushing for each jaw, side and surface with equal time to give equal importance to all surfaces. The music will be played in the class and students will perform the tooth brushing; listening to the music until they get able to brush properly.This music will be given to them to use at home every day. One week and two weeks after the beginning of the intervention, the intervention will be repeated.The post intervention examination will be done one month and two months after the beginning of the intervention.To prevent the contamination between the second group (ATP and art package) with other groups, interventions for the second group (ATP and art package) will be performed after the intervention of the other two groups. The control group (ATP) :Oral health education by ATP (Audio Tactile Performance) technique will be delivered to the students. A verbal oral health education will be delivered on the importance of teeth, oral hygiene, proper brushing, dental floss, fluoride, and the importance of controlling the consumption of sugar, in accordance with the age of the students. Then, the proper brushing technique will be taught individually by intra-oral guidance of the student's hand with the students' own toothbrush, until it is ensured that the student can properly handle it. one week and two weeks after the beginning of the intervention, the intervention will be repeated.Post-intervention examination will be done one month and two months after the beginning of the intervention. Treatment status. Timepoint: Baseline study, one month after the beginning of the intervention and two months after the beginning of the intervention. Method of measurement: Treatment index: First, the number of decayed, missing and filled teeth in primary (dmft) and permanent (DMFT) dentition, will be assessed.Treatment index will be calculated by these formulas:((M+F)/DMF)*100 and ((m+f)/dmf)*100 .Also, D, M, F, d, m, f indices will be reported separately. Gingival bleeding. Timepoint: Baseline study, one month after the beginning of the intervention and two months after the beginning of the intervention. Method of measurement: Bleeding on probing index (BOP): The presence or absence of gingival bleeding in all teeth will be evaluated using the WHO Periodontal Probe. The surrounding gingiva of each tooth is assessed for the presence or absence of bleeding. Oral hygiene. Timepoint: Baseline study, one month after the beginning of the intervention and two months after the beginning of the intervention. Method of measurement: Oral Hygiene Index-simplified (OHI-S): The Calculus Index (CI) and Debri Index (DI) for six teeth (16,11,26,36,31,46) will be evaluated and will be scored from 0 to 3 for each tooth and will be recorded in the examination form. The sum of calculus scores, divided by the number of examined teeth will represent the CI and and the sum of debri scores, divided by the number of examined teeth will represent the DI. Finally, the sum of CI and DI will be reported as OHI-S. Tehran University of Medical Sciences Approved 2018-10-14 Ethics committee of School of Dentistry, Tehran University of Medical Sciences School of Dentistry, Tehran University of Medical Sciences, North Kargar Ave, Tehran Tehran Tehran Iran (Islamic Republic of)