Clinical Trial

Effect of Individually Trained Oral Prophylaxis (iTOP) on Gingival Health in Orthodontic Patients

Completed
View on ClinicalTrials.gov →
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.
Protocol Amendment History 3 changes
critical Trial status changed: Not Yet Recruiting → Completed 2026-07-11
notable Primary completion moved earlier: 2026-09-30 -> 2026-06-30 2026-07-11
minor Completion moved earlier: 2026-09-30 -> 2026-06-30 2026-07-11
Trial Details
NCT Number NCT07468773
Lead Sponsor Gulf Medical University
Conditions Gingivitis, Orthodontic Treatment
Enrollment 60 participants
Start Date 2026-03-30
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-10