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

NCT07468773 | Not Yet Recruiting DMC

• 1 other identifier: IRB-COD-STD-67-FEB-2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Interdental Brushes; iTOP; Oral Hygiene Education; Approximal Plaque Index; Plaque Control

Outcome Measures

Primary Outcomes (1)

• Change in Approximal Plaque Index (API)

  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 Outcomes (2)

• Change in Gingival Index (GI)

  Baseline and 3 months

• Change in Full Mouth Bleeding Score (FMBS)

  Baseline and 3 months

Study Arms (2)

iTOP Oral Hygiene Training with Calibrated Interdental Brushes

EXPERIMENTAL

Experimental

Behavioral: Individually Trained Oral Prophylaxis (iTOP) Oral Hygiene Training

Conventional Oral Hygiene Instruction

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Touch-to-Teach Technique, Personalized

iTOP Oral Hygiene Training with Calibrated Interdental Brushes

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.

Also known as: Model Demonstration and Video-Based Oral Hygiene Education

Conventional Oral Hygiene Instruction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gulf Medical University: lead

Study Sites (1)

Gulf Medical University

Ajman, Ajman Emirate, 4184, United Arab Emirates

Location

MeSH Terms

Conditions

Gingivitis

Interventions

Precision Medicine

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Mohamed Atef Sayed

  Gulf Medical University

  STUDY CHAIR

• Fatema Ramadhan, M.D.S

  Gulf Medical University

  PRINCIPAL INVESTIGATOR

• Bhavna Kurkeja, Ph.D.

  Gulf Medical University

  STUDY DIRECTOR

Central Study Contacts

Mohamed Atef Sayed, Ph.D

CONTACT

+971581069908; dr.mohamedatef@gmu.ac.ae

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 13, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)