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

NCT ID: NCT07085013

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-06
• Study Completion Date: 2024-05-06

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.

Detailed Description

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

iTOP Oral Hygiene Training

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.

Group Type: EXPERIMENTAL

Individually Trained Oral Prophylaxis (iTOP)

Intervention Type: 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.

Control - No iTOP Training

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Individually Trained Oral Prophylaxis (iTOP)

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Mostar

OTHER

Sponsor Role: lead

Responsible Party

Zvonimir Lukac

Doctor of Dental Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

School of Medicine, University of Mostar

Mostar, HNŽ, Bosnia and Herzegovina

Countries

Bosnia and Herzegovina

References

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.

Reference Type: DERIVED

PMID: 41002677 (View on PubMed)

Other Identifiers

01-I-1827/21

Identifier Type: -

Identifier Source: org_study_id