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临床试验/NCT07085013
NCT07085013已完成不适用

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

University of Mostar2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2021年12月6日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
82
试验地点
2
主要终点
Change in Plaque Index from Baseline to 2-Year Follow-Up

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

Clinical periodontal assessments were performed by trained examiners who were blinded to the participants' group allocation in order to reduce measurement bias.

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Change in Bleeding on Probing from Baseline to 2-Year Follow-Up(Baseline, 3 months, and 2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zvonimir Lukac

Doctor of Dental Medicine

University of Mostar

研究点 (2)

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