An Investigation of the Efficacy of OHEM for Improving Oral Hygiene in Children
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-40
SponsorZiauddin University
About this trial
This pilot study evaluates the feasibility of conducting a larger Randomized Controlled Trial to compare three oral health education delivery methods to a control group. Except for the control group, mothers in the three intervention groups will receive the same oral health education based on the OHEM module but differ in the delivery methods, namely lecture, exhibition, and demonstration. All groups will receive a booklet and oral hygiene kits and be instructed to educate their children at home. Pre- and post-intervention assessments include the satisfaction of participants, the researchers' evaluation and cost of the trial, oral hygiene status, and the knowledge of the parents and children.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Mothers with children aged 12 to 15 years old, who are residing in Gulshan-e-Sikandarabad with no plan to move within the next 12 months.
Mothers with the ability to understand and read the Urdu language.
Only biological mothers with good physical and psychological health.
Disqualifiers
Mothers with new-born
Mothers with a history of receiving formal oral health promotion or preventive programs.
Aged 12,13,14, and 15 years old (studying in classes 6,7,8, and 9 respectively) residing in union council Gulshan-e-Sikandrabad,
Live with biological mothers at home,
Trial design
Design model
Parallel
Treatments tested in this trial
Oral Health Educational Module for Mothers (OHEM) lecture
BehavioralOHEM via lecture will be delivered to the mothers by an oral health professional who will be instructed to teach their children.
Oral Health Educational Module for Mothers (OHEM) exhibition
BehavioralOHEM via exhibition will be delivered to the mothers who will be instructed to teach their children.
Oral Health Educational Module for Mothers (OHEM) demonstration
BehavioralOHEM via demonstration will be delivered to the mothers by an oral health professional who will be instructed to teach their children.
Treatment groups
540 Participants
are divided into 4 treatment groupsGroup A: OHEM- LectureExperimental treatment 1 intervention
Group B: OHEM-ExhibitionExperimental treatment 1 intervention
Group C: OHEM-DemonstrationExperimental treatment 1 intervention
Group D: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Satisfaction of participants:
i. Are you satisfied with the program's organisation? ii. Are you satisfied with the researcher's attitude during the trial? iii. Are you satisfied with the recruitment process? iv. Are you satisfied with the intervention process? v. Are you satisfied with the content taught during the intervention? vi. Are you satisfied with the researcher's delivery of the content? vii. Are you satisfied with arranging the OHEM sessions at the venue? viii. Is the environment at the venue conducive to learning? ix. Are you satisfied with the baseline and final stage of the oral screening process? x. Do you trust the researcher that her research will be fruitful for you and your family? The satisfaction will be assessed using a 10-item questionnaire mentioned in the primary objective. Participants will respond to each question using a 5-point Likert scale rating; each item will be reported as the percentage of participants who are at least somewhat satisfied (score 3,4,5)
Time frame
six months2
Recruitment and participation of participants in the study
i) How well participants cooperated 1. During the recruitment/baseline data collection 2. During the intervention 3. During the follow-up/ final data collection process Additional comments by the researcher:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ The recruitment will be assessed on a Likert scale rating (very dissatisfied, dissatisfied, somewhat satisfied, satisfied, very satisfied); each item will be reported as the percentage of participants who are at least somewhat satisfied (score 3,4,5), whereas the participation of the participants will be assessed in percentage.
Time frame
six months3
Cost of the trial
The cost of the trial will be assessed by comparing the cost of the expenditure at the end of the trial. i) Travelling cost, ii) Preparation of materials for the OHEM lecture, exhibition, and demonstration session cost, iii) Conducting the OHEM lecture, exhibition, and demonstration sessions cost, iv) Cost of the incentives for the participants, v) Cost for the volunteers of the trial.
Time frame
six monthsSecondary outcomes
1
Dental plaque scores
Change in dental plaque scores among mothers and children between intervention and control groups, assessed pre- and post-intervention, using mean and Standard Deviation; lower scores will indicate good oral hygiene.
Time frame
six months2
Gingival scores
Change in gingival scores among mothers and children between intervention and control groups, assessed pre- and post-intervention, using mean and Standard Deviation; lower scores will indicate good oral hygiene.
Time frame
six months3
Oral health KAP scores
Change in oral health KAP scores among mothers and children between intervention and control groups, assessed pre and post-intervention, using mean and Standard Deviation; the higher scores indicate better KAP.
Time frame
six months4
Oral health behaviors
Change in skills (tooth brushing and dental flossing) among mothers and children between intervention and control groups, assessed pre- and post-intervention, using add scores; higher scores indicate good behaviours.
Time frame
six monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ziauddin University
Lead sponsor
Universiti Sains Malaysia
Collaborator
Source ClinicalTrials.gov
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