NCT07468773

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

Effect of Individually Trained Oral Prophylaxis (iTOP) Versus Conventional Oral Hygiene Instruction on Gingival Health in Orthodontic Patients Using Calibrated Interdental Brushes: A Randomized Controlled Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Gulf Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

Orthodontic patients with fixed appliances are at increased risk for plaque accumulation and gingival inflammation due to the presence of plaque-retentive surfaces created by orthodontic brackets and wires. Effective oral hygiene education is therefore essential to maintain periodontal health during orthodontic treatment. Traditional oral hygiene education methods, such as model demonstration and video instruction, provide general guidance but often lack individualized feedback and psychomotor skill training. The Individually Trained Oral Prophylaxis (iTOP) method introduces a personalized hands-on approach using the "Touch-to-Teach" concept, where clinicians guide the patient's hand to demonstrate correct interdental cleaning techniques using calibrated interdental brushes. This study compares the effectiveness of the iTOP method with conventional oral hygiene instruction in orthodontic patients diagnosed with gingivitis. The primary outcome measure is the change in the Approximal Plaque Index (API), while secondary outcomes include the Gingival Index (GI) and Full Mouth Bleeding Score (FMBS). These parameters are assessed at baseline and after a three-month follow-up period to determine improvements in plaque control and gingival health.

Conditions

• Gingivitis
• Orthodontic Treatment

Interventions

Type	Name	Description
BEHAVIORAL	Individually Trained Oral Prophylaxis (iTOP) Oral Hygiene Training	Participants receive individualized oral hygiene training using the Individually Trained Oral Prophylaxis (iTOP) method. The intervention is delivered in a one-to-one chairside session and uses the Touch-to-Teach technique, where the clinician guides the participant's hand to demonstrate correct toothbrushing and interdental cleaning movements. Calibrated interdental brushes are selected based on individual interdental space measurements using a color-coded interdental access probe. Participants practice the technique under supervision until proper technique is achieved. Reinforcement sessions are provided at 2 weeks, 1 month, and 3 months to ensure adherence and correct oral hygiene performance.
BEHAVIORAL	Conventional Oral Hygiene Instruction	Participants receive conventional oral hygiene education consisting of verbal explanation, model demonstration, and video-based instruction illustrating standard toothbrushing and interdental cleaning techniques. This educational approach provides visual and verbal guidance but does not include individualized calibration of interdental brushes or hands-on correction of brushing technique. Participants are instructed to brush twice daily and perform interdental cleaning once daily using the provided oral hygiene kit. Reinforcement sessions using the same demonstration and video-based instruction are conducted at 2 weeks, 1 month, and 3 months.

Timeline

• Start date: 2026-03-30
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2026-03-13
• Last updated: 2026-03-13

Locations

1 site across 1 country: United Arab Emirates