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临床试验/NCT04018534
NCT04018534已完成不适用

Effectiveness of Three Different Types Educational Methods on Implementation of Proper Oral Hygiene Behaviour Prior to Orthodontic Treatment

Okan University0 个研究点目标入组 90 人开始时间: 2014年5月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
主要终点
Plaque index(PI) for oral health assessment.

研究概览

简要总结

This study is a single-blind randomized controlled trial on fixed orthodontic appliance candidates (n = 90) assigned into a control group (n = 30) and two different study groups (n = 30 in each). Patients who requiring non-extraction fixed orthodontic treatment, crowding under 5mm in the incisors and heaving at least 20 permanent teeth with healthy periodontal tissue and devoid of caries were included in the study. The control group received a standard printed educational material assisted with verbal information. The study groups either received video assisted or hands-on training about fixed orthodontic appliance and oral hygiene. The time requirements for all three educational interventions were recorded at the initial visit. The adequacy of oral hygiene is documented through plaque and gingival indices at the initial visit and 8th week of the treatment.

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
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
12 Years 至 22 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Required non-extraction fixed orthodontic treatment, agree to use conventional stainless steel brackets (Gemini series; 3M Unitek, Monrovia, California, USA), at least 20 natural permanent teeth, crowding under 5 mm in the incisors and willing to participate in our research

排除标准

  • Dental caries, periodontal disease, systemic or chronic diseases such as diabetes, physical or mental disorders, smoking, previous orthodontic treatment, extensive dental restorations, antibiotic use during the previous 3 months, dental fluorosis and use of powered tooth brushes.

研究组 & 干预措施

Control group

Experimental

The patients in control group received a standard printed educational material assisted with verbal information in accordance with British Orthodontics Society(BOS) educational goals.

干预措施: Standard Verbal/Written Education (Behavioral)

Video assisted education group

Experimental

The patients in one of the study groups received a video assisted education

干预措施: Video Assisted Education (Behavioral)

Hands-on training group

Experimental

The patients in other study group received a hands-on training.

干预措施: Hands-on Training (Behavioral)

结局指标

主要结局

Plaque index(PI) for oral health assessment.

时间窗: PI was measured at the 8 weeks later in each patient.

The brushing habits of the patients were checked at each appointment and were recorded with PI. This measurement of the state of oral hygiene by Silness-Löe plaque index is based on recording both soft debris and mineralized deposits on the following teeth.

Gingival index(GI) for oral health assessment.

时间窗: GI was measured at the 8 weeks later in each patient.

This index was used to assess the severity and prevalence of gingivitis.Probe was used as a sensor for GI scoring and the mesial, distal, buccal and lingual surfaces of the teeth were evaluated in patients undergoing fixed orthodontic treatment.

次要结局

  • Time duration spent for educational interventions(Average 30 minutes)

研究者

发起方
Okan University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hakan Yilmaz

Assistant Professor

Okan University

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