Cluster RCT on the Effect of the Topics Number in Oral Health Educational Video Among Preschool Children.

NCT06073392 | Unknown DMC

• 2 other identifiers: USM/JEPeM/KK/23060506NMRR ID-23-01742-04F
• Study Type: interventional
• Target: 125
• Locations: 0 countries
• Sites: N/A

Brief Summary

Purpose: This cluster randomized controlled trials study aims to investigate whether different number of topics delivered through educational video affect the oral health status, knowledge, attitude and practice of preschool children. Hypothesis: The hypothesis of this study is the number of topics covered in educational videos aimed at preschool children will have a direct impact on their oral health status. The specific hypothesis is the educational videos covering wide range of oral health topics will lead to better oral health outcomes in preschool children compared to videos focusing on limited number of topics. The higher number of topics delivered in educational video, the better oral health status, knowledge, attitude, and practice. The alternative hypothesis is the combination of three topics on effective toothbrushing technique, effects of sugary food, and dental caries is effective to led to the most improvement in oral health status, knowledge, attitudes, and practices compared to two or only one topic. Objectives: The objectives of this study were divided into primary and secondary. The primary objective of the study is to assess the effect of different number of topics in educational video versus placebo video on mean difference in plaque score and gingival score among preschool children at baseline and 4 weeks after intervention. The secondary objective is to assess the effect of different number of topics in educational video versus placebo video on mean difference in knowledge, attitude and practice score among preschool children at baseline and 4 weeks after intervention. Participants: The study will involve 124 preschool children aged five to six years old. Methods: Researchers will randomize classes in the school into five clusters using closed enveloped technique. These five clusters will be randomly assigned either into interventional groups or control groups. There are four intervention groups and one control group. Each intervention group will be compared to a control group for mean difference in plaque, gingival and KAP score at baseline and after intervention. Duration: The study is expected to last 6 months (from subjects recruitment to final research report) with regular updates on progress. Location: The study will be conducted at a preschool in Kota Bharu Kelantan.

Conditions

Oral Health

Keywords

oral health; oral hygiene; dental plaque; gingivitis; child

Outcome Measures

Primary Outcomes (2)

• Plaque score using Modified Dental Plaque (MPI)

  The index will be calculate dental plaque on each tooth surface. The MPI score is obtained by the sum of the plaque score for all teeth, divided by the number of surfaces scored. Minimum value for the score is 0, while the maximum value is 5. The higher the score value describes the more plaque accumulation on each subject. Therefore, a high plaque score is interpreted as poor oral hygiene status. To give clinical relevance to the index, the index translated into four oral hygiene categories as 0 - 1.25: Excellent, 1.25 - 2.50: Good, 2.50 - 3.75: Fair, 3.75 - 5.00: Poor

  Baseline and 4 weeks after intervention

• Gingival Score using Modified Gingivitis Plaque (MGI)

  The index will be calculated the extent and the severity of gingival inflammation using four ordinals. The MGI score is obtained by the sum of the gingival score for all teeth, divided by the number of surfaces scored. The minimum value for the score is 0, while the maximum value is 3. The higher the score value describes the more severe inflammation due to plaque accumulation in subject. Therefore, a high gingival score is interpreted as poor gingival health. To give clinical relevance to the index, the index translated into three gingivitis categories, 0 : No gingivitis, ≤1.0 : Mild gingivitis, ≤2.0 : Moderate gingivitis, ≤3.0 : Severe gingivitis.

  Baseline and 4 weeks after intervention

Secondary Outcomes (1)

• Knowledge, Attitude, Practice (KAP) level using KAP score

  Baseline and 4 weeks after intervention

Study Arms (4)

Intervention Group 1 (IG1)

EXPERIMENTAL

Subjects in IG1 will be given a animation video screening in a specific room. IG1 intervention is on one topic cover only. The animation educational video covers on the topic of effective toothbrushing technique.

Other: Educational video

Intervention Group 2 (IG2)

EXPERIMENTAL

Subjects in IG2 will be given a animation video screening in a specific room. IG2 intervention is on two topics cover only. The animation educational video covers on the topic of effective toothbrushing technique and effects of sugary diet.

Other: Educational video

Intervention Group 3 (IG3)

EXPERIMENTAL

Subjects in IG3 will be given a animation video screening in a specific room. IG3 intervention is on two topics cover only. The animation educational video covers on the topic of effective toothbrushing technique, and dental caries.

Other: Educational video

Intervention Group 4 (IG4)

EXPERIMENTAL

Subjects in IG4 will be given a animation video screening in a specific room. IG4 intervention is on three topics cover. The animation educational video covers on the topic of effective toothbrushing technique, effects of sugary diet, and dental caries.

Other: Educational video

Interventions

Educational video OTHER

Educational video in animation mode

Intervention Group 1 (IG1); Intervention Group 2 (IG2); Intervention Group 3 (IG3); Intervention Group 4 (IG4)

Eligibility Criteria

• Age: 5 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged five to six years old and understand the Malay language.
• Children with normal cognitive and psychomotor ability equal to normal children aged five to six years old
• Children who unable to read and write fluently but able to understand instructions

You may not qualify if:

• Children with physical and psychological condition that prevents them from understanding and following the instruction.

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

MeSH Terms

Conditions

Dental Plaque; Gingivitis

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases

Study Officials

• SITI NUR BAIDURI MOHD JAINI

  SCHOOL OF DENTAL SCIENCES, UNIVERSITI SAINS MALAYSIA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SITI NUR BAIDURI MOHD JAINI

CONTACT

0196699269; drnurbaiduri@student.usm.my

MOHD ZULKARNAIN SINOR

CONTACT

09-7670000; zulkarnainsinor@usm.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Masking: Single-blinded, where participants are unaware of the type of intervention given to them (in which combination and either 1 topics, 2 topics or 3 topics)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Model is multiple-arm parallel group. There are multiple-arm trials, four experimental are versus single-control arm. Four experimental arms intervention are: 1. effective toothbrushing technique (1 topic) 2. effective toothbrushing technique, effects of sugary diet (2 topics) 3. effective toothbrushing technique, and dental caries (2 topics) 4. effective toothbrushing technique, effects of sugary diet, and dental caries (3 topics) Single placebo arms is topic on tooth anatomy and eruption

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 10, 2023
• Study Start: October 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 11, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share