Evaluating Methods of Dental Health Instructions on the Oral Health Indices of 12-18-year-old Patients With Fixed Orthodontics Referring to the Orthodontic Department and Clinic of Tehran University of Medical Sciences, A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change in Plaque Index (PI)
研究概览
简要总结
The goal of this clinical trial is to learn which type of oral health education works best to help 12-18-year-old participants with fixed orthodontic appliances (braces) keep their mouths healthy. The main questions it aims to answer are:
Which method of oral hygiene instruction-video-based, written, or face-to-face education-is most effective in improving oral health?
Do these education methods help lower dental plaque and gum inflammation during orthodontic treatment?
Researchers will compare the three groups of participants who receive different types of oral hygiene training to see which method leads to the best oral health results.
Participants will:
Receive one of three types of oral hygiene instruction (video, written, or in-person).
Continue their regular orthodontic care and brushing routine.
Have their oral health checked at different times during the study to measure changes in plaque and gum health.
The study hopes to identify the most effective and practical way to teach young orthodontic patients to keep their teeth and gums healthy while wearing braces.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with fixed orthodontics aged 12 to 18 years
- •Patient cooperation to participate in the study and follow-up
- •Patients with no history of systemic and mental illnesses and no use of neuropsychiatric medications
- •Patients who are not participating in another study related to oral health
- •Patients who do not have caries or periodontal problems at the beginning of orthodontic treatment (GI, PI, and BOP indices are less than 10%)
- •Patients whose brackets have been placed by an orthodontist (specialized department and special clinic) and under the bonding principles mentioned in the text books.
排除标准
- •Patients who are not cooperative.
- •Patients with systemic diseases and cleft palate and syndromes affecting the study results and health indicators.
- •Patients with caries or periodontal problems with significant Clinical Attachment Loss (GI, PI and BOP indices are more than 10%)
- •Patients using medications that affect plaque adhesion, such as mouthwashes
- •Patients with a history of long-term antibiotic use
- •Patients with dental anomalies
- •Patients with mental and physical problems that prevent oral hygiene
- •Patients with dental impaction
- •Patients with a treatment plan that includes extraoral appliances
研究组 & 干预措施
Face-to-face Oral Hygiene Instruction
Participants receive traditional chairside oral hygiene instruction delivered verbally by a trained dentist or oral health educator. Instructions include proper toothbrushing technique, use of fluoride toothpaste, interdental cleaning, and care of orthodontic appliances.
干预措施: Verbal Oral Hygiene Instruction (Behavioral)
Video-Based Oral Hygiene Instruction
Participants receive oral hygiene instruction using a video and visual demonstration on toothbrushing, interdental cleaning, and care of orthodontic appliances.
干预措施: Video-Based Oral Hygiene Instruction (Behavioral)
Pamphlet-based Oral Hygiene Instruction
Participants receive oral hygiene instruction through a printed educational pamphlet containing text and illustrations about proper toothbrushing technique, interdental cleaning, use of fluoride toothpaste, and care of orthodontic appliances.
干预措施: Pamphlet-Based Oral Hygiene Instruction (Behavioral)
结局指标
主要结局
Change in Plaque Index (PI)
时间窗: Baseline and 4 weeks after intervention
The Plaque Index (PI) will be measured using the Silness and Löe method to assess the level of dental plaque accumulation. The outcome represents the change in PI scores from baseline to 4-week follow-up among participants in the three intervention groups (verbal, pamphlet, video). Lower scores indicate improved oral hygiene status. The measure evaluates the effectiveness of each instructional method in reducing plaque accumulation in adolescents with fixed orthodontic appliances.
次要结局
未报告次要终点