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Completed

NCT Number: NCT07085013

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Medicine, University of Mostar

Mostar, HNŽ, 88000, Bosnia and Herzegovina

About this study

This is a prospective, two-year cohort study conducted at the School of Medicine, University of Mostar (Bosnia and Herzegovina), during the 2021/2022 and 2023/2024 academic years. The study is designed to evaluate the long-term effectiveness of a single-session oral hygiene education program, known as Individually Trained Oral Prophylaxis (iTOP), on periodontal health in medical and dental students.

  • Study Population and Setting: Participants include first- and fourth-year students of medicine and dental medicine at the University of Mostar during the 2021/2022 academic year. Eligibility criteria include active enrollment and provision of informed consent. Students with systemic diseases affecting periodontal health (e.g., uncontrolled diabetes) or those using medications known to cause gingival overgrowth will be excluded.
  • Study Design: Participants will be randomly assigned using a computer-generated list to either the intervention group (iTOP) or the control group. Group allocation will be concealed from examiners to minimize assessment bias. Both groups will receive professional dental cleaning and standardized oral hygiene kits at each examination point. Clinical assessments will be performed by a board-certified periodontist and a calibrated teaching assistant.
  • Intervention: The intervention group will receive individualized oral hygiene instruction based on the certified iTOP methodology. This includes hands-on training in toothbrushing, interdental brush use, and flossing. A follow-up motivational session will be scheduled at 3 months. The control group will receive no structured oral hygiene education beyond standard cleaning and kit distribution. Adherence to oral hygiene recommendations will not be systematically monitored.
  • Outcomes and Assessments: The primary clinical outcomes include plaque index, bleeding on probing, probing depth, and clinical attachment level. These will be measured at six sites per tooth using a UNC-15 periodontal probe and recorded on the Bern Periodontal Chart. Assessments are scheduled at baseline (2021/2022), at 3 months, and at the 2-year follow-up (2023/2024). Standardized oral hygiene kits (Curaprox toothbrushes and interdental brushes) will be provided at each time point.
  • Statistical Analysis: Planned statistical analyses include both descriptive and inferential methods. Normality will be assessed using the Kolmogorov-Smirnov test. Comparative analyses will use appropriate non-parametric or parametric tests such as the Mann-Whitney U, Wilcoxon signed-rank, Friedman, Chi-square, or Fisher's exact test. All analyses will be conducted using SPSS software (version 26), with significance set at p < 0.05.
  • Ethical Considerations: The study was approved by the Ethics Committee of the School of Medicine, University of Mostar (Approval numbers 01-I-1827/21 and 01-I-911/24) and will be conducted in accordance with the Declaration of Helsinki. Written informed consent will be obtained from all participants prior to enrollment.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Baseline, 3 months, and 2 years

    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.

Secondary outcomes

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

    Time frame: Baseline, 3 months, and 2 years

    Bleeding on probing was recorded at six sites per tooth using a UNC-15 probe. This measure evaluates the impact of the iTOP training on gingival inflammation over time.

Other outcomes

  1. Change in Self-Reported Smoking Behavior Over 2 Years

    Time frame: Baseline and 2-Year Follow-Up

    Participants self-reported their smoking status using a study-specific questionnaire administered at baseline and again at the 2-year follow-up. Smoking status was assessed with the question: "Do you currently smoke cigarettes or other tobacco products?", with response options:

    • Yes (current smoker)
    • No (non-smoker)

    Responses were used to calculate the prevalence of smoking within the study population at both time points. The outcome measures the change in smoking behavior over time. Higher prevalence rates reflect greater exposure to a potential confounding factor for periodontal outcomes.

    Note: No standardized or validated scale was used. This was a binary (yes/no) self-report item.

Sponsors and collaborators

Lead sponsor

University of Mostar

Other

Registry information

Official study title

Effectiveness of Individually Trained Oral Prophylaxis Education on Long-Term Oral Health in Medical and Dental Students: A Two-Year Prospective Cohort Study

Acronym: iTOP

Important dates

Study start
2021
Primary completion
2022
Study completion
2024
First posted
Jul 25, 2025
Registry last updated
Jul 25, 2025

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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