Oral HealthiTOPNCT07085013
Effectiveness of Personalized Oral Hygiene Education in Medical and Dental Students Over Two Years
A study testing Individually Trained Oral Prophylaxis (iTOP) in people with Oral Health and Oral Hygiene, run by University of Mostar at 1 site in Bosnia and Herzegovina.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Oral Health, Oral Hygiene, Periodontal Health
- What is being tested?
- Individually Trained Oral Prophylaxis (iTOP)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteBosnia and Herzegovina
- Study dates
- 6 Dec 2021to 6 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Bosnia and Herzegovina1 site
School of Medicine, University of Mostar
Mostar, HNŽ, 88000
About this study
Official title: Effectiveness of Individually Trained Oral Prophylaxis Education on Long-Term Oral Health in Medical and Dental Students: A Two-Year Prospective Cohort Study
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.
Read the 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
- Being tested
- Individually Trained Oral Prophylaxis (iTOP)
- Keywords
- iTOP, Oral Health, Oral Hygiene, Dental Plaque, Periodontal Health, Oral Health Education, Preventive Dentistry, Medical Students, Dental Students
- Medical subject headings
- Dental Plaque, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individually Trained Oral Prophylaxis (iTOP)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months, and 2 years
Secondary outcomes (1)
Change in Bleeding on Probing from Baseline to 2-Year Follow-Up
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.
Measured: Baseline, 3 months, and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start6 Dec 2021
- Primary completion4 Apr 2022
- Study completion6 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mostar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zvonimir Lukac, University of Mostar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07085013
- Sponsor's protocol ID
- 01-I-1827/21
- Acronym
- iTOP
- Status last verified
- Jul 2025
- First submitted
- 14 Jul 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data (IPD) will be available upon reasonable request to the principal investigator following publication, for research purposes only, and with appropriate data use agreements.
Publications
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.
PubMed 41002677
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Individually Trained Oral Prophylaxis Education on Long-Term Oral Health in Medical and Dental Students: A Two-Year Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07085013
- Acronym / sponsor ID
- iTOP / 01-I-1827/21
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of MostarUniversity, hospital or other
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 4 Apr 2022 (actual)
- Study completion
- 6 May 2024 (actual)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| iTOP Oral Hygiene Training | Experimental | Behavioral: Individually Trained Oral Prophylaxis (iTOP)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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | iTOP Oral Hygiene Training |
Primary outcome
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.
1 secondary outcome
Change in Bleeding on Probing from Baseline to 2-Year Follow-Up
Time frame: Baseline, 3 months, and 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Derived from this study: PubMed 41002677Lukac 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.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data (IPD) will be available upon reasonable request to the principal investigator following publication, for research purposes only, and with appropriate data use agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individually Trained Oral Prophylaxis (iTOP) in people with Oral Health and Oral Hygiene, run by University of Mostar at 1 site in Bosnia and Herzegovina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bosnia and Herzegovina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Plaque Index from Baseline to 2-Year Follow-Up (time frame: Baseline, 3 months, and 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07085013, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.