Effectiveness of Personalized Oral Hygiene Education in Medical and Dental Students Over Two Years

NCT07085013 | Completed

• 1 other identifier: 01-I-1827/21
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective cohort study is designed to evaluate the long-term effects of individualized oral hygiene education, known as Individually Trained Oral Prophylaxis (iTOP), on oral health outcomes in medical and dental students at the University of Mostar, Bosnia and Herzegovina. Participants will be randomly assigned to either an intervention group receiving personalized oral hygiene training (iTOP) or a control group. Both groups will receive professional dental cleaning and standardized oral hygiene kits. Clinical parameters will be assessed at baseline, after 3 months, and at a 2-year follow-up.

Conditions

Oral Health; Oral Hygiene; Periodontal Health; Dental Plaque; Bleeding on Probing; Health Education

Keywords

iTOP; Oral Health; Oral Hygiene; Dental Plaque; Periodontal Health; Oral Health Education; Preventive Dentistry; Medical Students; Dental Students

Outcome Measures

Primary Outcomes (1)

• Change in Plaque Index from Baseline to 2-Year Follow-Up

  The plaque index was measured using the Bern Periodontal Chart (Periochart) at six sites per tooth, with plaque disclosing agents to identify plaque presence. The outcome is expressed as the percentage of tooth surfaces with visible plaque, ranging from 0% (no plaque present) to 100% (plaque present on all examined surfaces). Higher percentages indicate worse oral hygiene. This measure evaluates the effectiveness of the iTOP intervention in reducing plaque accumulation over time.

  Baseline, 3 months, and 2 years

Secondary Outcomes (1)

• Change in Bleeding on Probing from Baseline to 2-Year Follow-Up

  Baseline, 3 months, and 2 years

Other Outcomes (1)

• Change in Self-Reported Smoking Behavior Over 2 Years

  Baseline and 2-Year Follow-Up

Study Arms (2)

iTOP Oral Hygiene Training

EXPERIMENTAL

Participants in this arm received a structured, single-session, small-group training based on the Individually Trained Oral Prophylaxis (iTOP) protocol. The session lasted approximately 45 minutes and was led by certified dental professional. It included personalized assessment, demonstration, and hands-on practice of effective toothbrushing techniques and interdental cleaning. A brief motivational reinforcement session was provided at the 3-month follow-up. Participants received standardized oral hygiene kits at each study visit.

Behavioral: Individually Trained Oral Prophylaxis (iTOP)

Control - No iTOP Training

NO INTERVENTION

Participants in this arm did not receive the iTOP oral hygiene training. They continued their usual oral hygiene routines and received no additional educational interventions. However, they received standardized oral hygiene kits and professional dental cleaning at baseline, 3-month, and 2-year follow-up visits, similar to the intervention group. Clinical assessments were conducted at each time point by blinded examiners.

Interventions

Individually Trained Oral Prophylaxis (iTOP) BEHAVIORAL

The iTOP intervention consists of a single, structured, 45-minute, small-group oral hygiene training session conducted by certified dental professional. The session includes personalized instruction on proper toothbrushing techniques (e.g., Bass technique), use of interdental brushes and floss, and patient motivation. At the 3-month follow-up, participants also received a short reinforcement session. Standardized oral hygiene kits (toothbrush, interdental brushes) were provided at each time point.

iTOP Oral Hygiene Training

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Active enrollment as a student in either:
• First or fourth year during the 2021/2022 academic year, or
• Third or sixth year during the 2023/2024 academic year
• Enrollment verified by Faculty Administration records
• Provided written informed consent

You may not qualify if:

• Did not provide informed consent
• Presence of systemic conditions known to affect periodontal health (e.g., uncontrolled diabetes, immunodeficiencies)
• Use of medications known to cause gingival overgrowth, including:
• Anticonvulsants
• Calcium channel blockers
• Immunosuppressants

Sponsors & Collaborators

• University of Mostar: lead

Study Sites (1)

School of Medicine, University of Mostar

Mostar, HNŽ, 88000, Bosnia and Herzegovina

Location

Related Publications (1)

• Lukac Z, Maric B, Kapetanovic J, Mandic M, Musa Leko I, Bosnjak AP. Effectiveness of Individually Trained Oral Prophylaxis (iTOP) Education on Long-Term Oral Health in Medical and Dental Students: A Two-Year Prospective Cohort Study. Dent J (Basel). 2025 Sep 3;13(9):404. doi: 10.3390/dj13090404.

  PMID: 41002677 DERIVED

MeSH Terms

Conditions

Dental Plaque; Health Education

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Clinical periodontal assessments were performed by trained examiners who were blinded to the participants' group allocation in order to reduce measurement bias.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Dental Medicine

Model Details: This is a randomized controlled trial using a parallel-group design. Participants were randomly assigned to either an intervention group receiving iTOP oral hygiene training or a control group receiving no training. Both groups were followed over two years with assessments at baseline, 3 months, and 2 years.

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: July 25, 2025
• Study Start: December 6, 2021
• Primary Completion: April 4, 2022
• Study Completion: May 6, 2024
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Deidentified individual participant data (IPD) and supporting documents will be available beginning 6 months after publication of the main results, and will be accessible for up to 5 years.
• Access Criteria: Access will be granted to qualified researchers upon reasonable request. Data will include deidentified individual participant data (IPD), study protocol, informed consent form, and statistical analysis plan. Interested researchers should contact the principal investigator via institutional email and provide a brief study proposal and data use agreement.

Locations

BO (1)