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

March 9, 2026 updated by: Gulf Medical University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Arab Emirates
    • Ajman Emirate
      • Ajman, Ajman Emirate, United Arab Emirates, 4184
        • Gulf Medical University
        • Contact:
        • Principal Investigator:
          • Fatema Ramadhan, M.D.S
        • Sub-Investigator:
          • Mohamed Atef Sayed, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: iTOP Oral Hygiene Training with Calibrated Interdental Brushes
Experimental
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.
Other Names:
  • Touch-to-Teach Technique
  • Personalized
Active Comparator: Conventional Oral Hygiene Instruction
Participants receive conventional oral hygiene education through model demonstration and video-based instruction. The session includes verbal explanation of toothbrushing and interdental cleaning techniques without individualized hands-on training. Reinforcement sessions are conducted at 2 weeks, 1 month, and 3 months.
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.
Other Names:
  • Model Demonstration and Video-Based Oral Hygiene Education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at Baseline and 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 3 months
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.
Baseline and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gulf Medical University

Investigators

  • Study Chair: Mohamed Atef Sayed, Gulf Medical University
  • Principal Investigator: Fatema Ramadhan, M.D.S, Gulf Medical University
  • Study Director: Bhavna Kurkeja, Ph.D., Gulf Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 30, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-COD-STD-67-FEB-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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