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Completed NCT07468773

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

Conditions: Gingivitis, Orthodontic Treatment

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 60
Sponsor: Gulf Medical University

Location: Gulf Medical University Ajman Ajman Emirate

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.

Eligibility Criteria

Inclusion Criteria: 1. Adults aged 18 years or older 2. Patients undergoing fixed orthodontic treatment 3. Diagnosis of biofilm-induced gingivitis 4. Presence of interdental spaces suitable for calibrated interdental brush use 5. Ability and willingness to perform oral hygiene procedures and attend follow-up visits 6. Provision of written informed consent Exclusion Criteria: 1. Presence of systemic diseases affecting gingival health (e.g., uncontrolled diabetes) 2. Use of medications known to influence gingival conditions (e.g., phenytoin, cyclosporine, calcium channel blockers) 3. History of chemotherapy or radiotherapy in the head and neck region 4. Current smokers 5. Pregnant or lactating women 6. Patients with physical or cognitive disabilities affecting oral hygiene performance 7. Use of additional professional oral hygiene interventions or antimicrobial mouth rinses during the study period

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07468773). StuddyBuddy aggregates publicly available trial information.