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NCT Number: NCT07468773

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

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.

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Key information

Conditions

Gingivitis Gingival Diseases Infections Mouth Diseases Orthodontic Treatment Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gulf Medical University

Ajman, Ajman Emirate, 4184, United Arab Emirates

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Ability and willingness to perform oral hygiene procedures and attend follow-up visits
  • Provision of written informed consent

Exclusion criteria

  • 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
  • Pregnant or lactating women
  • Patients with physical or cognitive disabilities affecting oral hygiene performance
  • Use of additional professional oral hygiene interventions or antimicrobial mouth rinses during the study period

Treatment and study plan

Individually Trained Oral Prophylaxis (iTOP) Oral Hygiene Training

Behavioral

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.

Other names: Touch-to-Teach Technique, Personalized

Conventional Oral Hygiene Instruction

Behavioral

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.

Other names: Model Demonstration and Video-Based Oral Hygiene Education

Primary outcomes

  1. Change in Approximal Plaque Index (API)

    Time frame: at Baseline and 3 months

    The Approximal Plaque Index (API) is used to evaluate plaque accumulation at interdental surfaces. Plaque is disclosed using a disclosing agent and each approximal surface is scored as the presence or absence of plaque. The API score is calculated as the percentage of interdental surfaces with visible plaque relative to the total number of surfaces examined. Lower values indicate improved plaque control.

Secondary outcomes

  1. Change in Gingival Index (GI)

    Time frame: Baseline and 3 months

    The Gingival Index is used to assess the severity of gingival inflammation. The gingiva around each tooth is evaluated at four surfaces (mesial, distal, facial, and lingual) and scored from 0 to 3, where 0 indicates healthy gingiva and 3 indicates severe inflammation with spontaneous bleeding. Lower scores indicate improvement in gingival health.

  2. Change in Full Mouth Bleeding Score (FMBS)

    Time frame: Baseline and 3 months

    The Full Mouth Bleeding Score evaluates gingival inflammation by recording bleeding on probing at six sites per tooth. The score is calculated as the percentage of sites that show bleeding after gentle probing. Higher percentages indicate greater gingival inflammation, while lower values reflect improved gingival health.

Sponsors and collaborators

Lead sponsor

Gulf Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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