An Investigation of the Efficacy of OHEM for Improving Oral Hygiene in Children (NCT06356402) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
An Investigation of the Efficacy of OHEM for Improving Oral Hygiene in Children
Pakistan540 participantsStarted 2024-10
Plain-language summary
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.
Who can participate
Age range
12 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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,
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Satisfaction of participants:
Timeframe: six months
2
Recruitment and participation of participants in the study
. Present with moderate to severe plaque accumulation and gingivitis during oral screening.
. Have genetic or medical conditions, such as physical and psychological disabilities that can affect the comprehension of instruction and tooth brushing activities, such as learning disabilities or auditory or visual disorders.
. Have genetic dental anomalies such as anodontia, amelogenesis imperfecta, and supernumerary teeth.
. Have been previously exposed to any form of oral health education.