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临床试验/NCT07826715
NCT07826715已完成不适用

Personalized 3D Visualization for Oral Hygiene and Motivation in Adults With Gingivitis

Abant Izzet Baysal University1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2021年8月15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
入组人数
88
试验地点
1
主要终点
Change in Full-Mouth Rustogi Modified Navy Plaque Index From Baseline to Week 6

研究概览

简要总结

This study evaluated whether personalized three-dimensional images of possible future changes in the gums could improve oral hygiene and motivation in adults with gingivitis. Gingivitis is inflammation of the gums associated with dental plaque.

Eighty-four adults aged 18-60 years were randomly assigned to three groups of 28 participants. The groups received conventional oral hygiene education, general three-dimensional educational animations, or personalized three-dimensional visualization using models created from their own intraoral scans. All participants received the same nonsurgical periodontal treatment and instruction in toothbrushing and cleaning between the teeth.

The personalized images illustrated possible gum recession and tissue changes if periodontal care and daily plaque control were neglected. They were educational scenarios, not individual predictions of future disease. Personalized visualization was accompanied by a clinician-guided motivational discussion.

Dental plaque, gum inflammation, gum bleeding, and motivation toward dental treatment were assessed before treatment and six weeks later. The study compared these outcomes among the three educational approaches.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18-60 years. Systemically healthy. Diagnosis of gingivitis according to the 2017 World Workshop classification. At least 20 natural teeth, excluding third molars. At least 12 years of formal education. Turkish as the native language. Probing depths ≤3 mm. Bleeding on probing at more than 10% of sites. Visible plaque at more than 50% of sites. Provision of written informed consent.

排除标准

  • Dentists or dental students. Previous periodontal treatment or structured oral hygiene education. Use of antibiotics or nonsteroidal anti-inflammatory drugs within the preceding 3 months.
  • Generalized gingival recession or dentin hypersensitivity. Full-arch fixed or removable prostheses. Acute odontogenic infections. Overhanging or defective restorations, or root caries that could affect oral hygiene practices.
  • Active orthodontic treatment. Communicable diseases such as hepatitis or HIV infection. Cognitive, systemic, or physical conditions that could interfere with understanding the educational content or performing oral hygiene practices.

研究组 & 干预措施

Conventional Method (CM)

Active Comparator

Participants received nonsurgical periodontal treatment and conventional face-to-face oral hygiene education supported by practical demonstrations using a dental model and a written information leaflet. Education covered periodontal disease, dental plaque, and daily oral hygiene practices, including the modified Bass toothbrushing technique and appropriate interdental cleaning.

干预措施: Conventional Oral Hygiene Education (Behavioral)

Three-Dimensional Animation (3DA)

Active Comparator

Participants received nonsurgical periodontal treatment and clinician-guided oral hygiene education using DentalMaster three-dimensional educational software. The educational content covered the causes and clinical signs of periodontal diseases, periodontal treatment, and daily oral care. General three-dimensional animations illustrated potential gingival recession, periodontal tissue loss, and tooth loss associated with inadequate plaque control. Participants were instructed in the modified Bass toothbrushing technique and appropriate interdental cleaning.

干预措施: Three-Dimensional Animation-Based Oral Hygiene Education (Behavioral)

Periodontal Disease Prediction (PDP)

Active Comparator

Participants received nonsurgical periodontal treatment and clinician-guided education on periodontal disease and daily oral care. Personalized three-dimensional dentogingival models generated from their intraoral scans using the Periodontal Disease Prediction (PDP) system illustrated potential gingival recession and visible tissue changes if periodontal care and plaque control were neglected. Images were presented as conditional educational scenarios, not individualized prognostic predictions. Visualization was accompanied by a motivational discussion addressing personal goals and barriers to oral hygiene. Participants were instructed in the modified Bass toothbrushing technique and appropriate interdental cleaning.

干预措施: Personalized Three-Dimensional Visualization With Motivational Discussion (Behavioral)

结局指标

主要结局

Change in Full-Mouth Rustogi Modified Navy Plaque Index From Baseline to Week 6

时间窗: Baseline and 6 weeks

Dental plaque was assessed using the Rustogi Modified Navy Plaque Index (RMNPI) after application of a plaque-disclosing agent. The facial and lingual/palatal surfaces of each eligible tooth were divided into nine areas, scored as 0 for absence of plaque or 1 for presence of plaque. The full-mouth score was calculated as the proportion of assessed areas with plaque, ranging from 0 to 1, with higher scores indicating more plaque. Third molars and teeth with crowns or cervical restorations were excluded. Change was calculated as the week 6 score minus the baseline score; negative values indicate improvement.

次要结局

  • Change in Full-Mouth Gingival Index From Baseline to Week 6(Baseline and 6 weeks)
  • Change in Full-Mouth Papillary Bleeding Index From Baseline to Week 6(Baseline and 6 weeks)
  • Intrinsic Motivation Assessed by the Dental Treatment Motivation Scale(Baseline and 6 weeks)
  • Extrinsic Motivation Assessed by the Dental Treatment Motivation Scale(Baseline and 6 weeks)

研究者

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

Zeynep AKGÜL

Assist Prof

Abant Izzet Baysal University

研究点 (1)

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