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

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.

Conditions

• Gingivitis
• Orthodontic Treatment

Interventions

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.

Sponsors & Collaborators

• Gulf Medical University

  lead OTHER

Principal Investigators

• Mohamed Atef Sayed · Gulf Medical University

• Fatema Ramadhan, M.D.S · Gulf Medical University

• Bhavna Kurkeja, Ph.D. · Gulf Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-03-30

Primary Completion

2026-09-30

Completion

2026-09-30

Countries

• United Arab Emirates

Study Locations