Effect of Individually Trained Oral Prophylaxis (iTOP) on Gingival Health in Orthodontic Patients (NCT07468773) | Clinical Trial Compass
CompletedNot Applicable
Effect of Individually Trained Oral Prophylaxis (iTOP) on Gingival Health in Orthodontic Patients
United Arab Emirates60 participantsStarted 2026-03-30
Plain-language summary
This randomized controlled clinical trial aims to evaluate the effectiveness of individualized oral hygiene education using the Individually Trained Oral Prophylaxis (iTOP) method compared with conventional oral hygiene instruction using model demonstration and video-based education in orthodontic patients diagnosed with gingivitis.
Sixty orthodontic patients underwent professional mechanical plaque removal and received oral hygiene instruction using calibrated interdental brushes. Participants were randomly assigned to either the iTOP training group or the conventional education group.
Clinical outcomes including Approximal Plaque Index (API), Gingival Index (GI), and Full Mouth Bleeding Score (FMBS) were assessed at baseline and after three months to determine the effectiveness of the educational interventions on plaque control and gingival health.
Who can participate
Age range
18 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
. Adults aged 18 years or older
. Patients undergoing fixed orthodontic treatment
. Diagnosis of biofilm-induced gingivitis
. Presence of interdental spaces suitable for calibrated interdental brush use
. Ability and willingness to perform oral hygiene procedures and attend follow-up visits
. Provision of written informed consent
Exclusion criteria
. Presence of systemic diseases affecting gingival health (e.g., uncontrolled diabetes)
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.