Effect of Individually Trained Oral Prophylaxis (iTOP) on Gingival Health in Orthodontic Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGulf Medical University
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Presence of systemic diseases affecting gingival health (e.g., uncontrolled diabetes)
Use of medications known to influence gingival conditions (e.g., phenytoin, cyclosporine, calcium channel blockers)
History of chemotherapy or radiotherapy in the head and neck region
Current smokers
Trial design
Treatments tested in this trial
- Individually Trained Oral Prophylaxis (iTOP) Oral Hygiene Training
- Conventional Oral Hygiene Instruction
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov