The Immediate Effectiveness of a 3D Intraoral Scanner as an Adjunctive Oral Hygiene Educational Tool: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Full mouth plaque score (%)
研究概览
简要总结
The goal of this randomized controlled clinical trial is to compare the immediate effectiveness of 3D intra-oral scanners and standard oral hygiene instructions in improving the oral hygiene of 52 subjects. The main question[s] it aims to answer are:
- Does a 3D intra-oral scanner facilitate the improvement of oral hygiene in subjects?
- Does a 3D-rendered image of plaque-stained teeth confer better visualization to subjects?
Prospective Open Cohort study: Patients referred to NUCOHS Periodontology Department will be invited to participate in the study. Included participants will be randomized into the 3D scanner (test) and standard oral hygiene (control) group. Subsequently, both groups will receive personalized oral hygiene instructions before brushing their teeth. The participants will receive plaque disclosing again to compare the differences between baseline and post-intervention.
Routine periodontal parameters will be recorded at baseline and researchers will compare the percentage improvement in full mouth plaque scores to see if the test group performed better than the control group.
A questionnaire will be given to subjects in the test and control group for qualitative analysis.
The study will require 1 visit.
详细描述
Subjects:
The randomized controlled study will include 52 healthy volunteers from the National University Centre of Oral Health (NUCOHS), Department of Periodontology. The sample size is calculated with the assumption of a large Cohen effect size. The subjects are patients undergoing periodontal therapy in the center. After written informed consent has been obtained, the baseline periodontal parameters will be obtained to assess for inclusion and exclusion criteria. Successfully included participants will be randomized into 2 groups by blinded study team members.
There will be 2 groups:
- Test (n=26): 3D intra-oral scanning group.
- Control (n=26): standard oral hygiene instructions (no 3D intra-oral scanning).
Examiner:
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 (Investigator)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy patients (ASA I and ASA II)
- •≥ 20 teeth, excluding impacted third molars
- •, between ages 21 and 75 years
- •plaque score (PS) ≥ 50%
- •Bleeding on probing ≥ 30% of sites
- •At least 1 molar is present on each sextant
- •Probing pocket depths (PPD) should be ≤ 6 mm (h) Willingness to give consent
排除标准
- •Presence of PPD ≥ 7 mm, excluding the distal of 7s due to impacted wisdom teeth
- •Presence of fixed retainers
- •Presence of fixed orthodontic appliances
- •Pregnant and lactating patients
- •Cognitive impairments
- •Initiation of antibiotic therapy or antiseptic mouth rinse within 2 weeks before the study
- •Patients with known neuromotor deficits e.g. Parkinsonism, Dementia, Alzheimer's Disease
- •Diseases or medications, medications that may affect treatment
- •Heavy smokers ≥ 10 sticks/day,
- •Unwillingness to undergo periodontal treatment
- •Uncontrolled diabetes mellitus and hypertension
- •Teeth with crowns and bridges
- •Unwillingness to undergo the proposed protocol
结局指标
主要结局
Full mouth plaque score (%)
时间窗: Immediate/1 day
Difference in Full Mouth Plaque Score using the two tone plaque disclosing liquid by Curaprox
次要结局
- Patient's satisfaction of 3D scanner and standard oral hygiene group based on 5-point Likert Scale(Immediate/1 day)