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临床试验/NCT05079204
NCT05079204已完成不适用

Effectiveness of Intraoral Scanners as a Motivation Method for Oral Hygiene Instruction

CHU de Reims2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2022年9月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
CHU de Reims
入组人数
1
试验地点
2
主要终点
Plaque Control Record Evolution

研究概览

简要总结

Periodontal diseases are highly prevalent inflammatory diseases. These diseases are mostly due to the development and the maturation of bacterial plaque which lead to local inflammation. Individuals can develop severe attachment loss which could lead to dental loss. To prevent them, individual plaque removal procedures self-performed by the patient by tooth brushing or interdental brushes or made by professional care (scaling), are known to improve periodontal health, and thus to prevent periodontal diseases. Moreover, oral hygiene is a major factor to increase increasing the outcomes when treatments are needed. However, patients' compliance in oral health program is one of the major limits to periodontal therapeutics.

In this study, the investigators evaluate the effectiveness of 3D intra-oral camera compared with conventional oral hygiene instructions, to improve oral health motivation.

详细描述

The present study explores the effectiveness of intraoral scanners in the field of oral hygiene motivation and instruction to improve the patient's motivation.

Patients presenting periodontitis or gingivitis are recruited and randomized in 2 groups: conventional motivation procedures and conventional motivation procedures supported with 3D representations of their mouth obtained by intraoral scanners. Periodontal diseases (periodontitis and gingivitis) will be diagnosed according to the international classification of periodontal diseases, based on the decision-making algorithms. A periodontal charting, socio-demographic data and clinical data will be collected. Then, oral mucosa dermatological manifestations, treatment needs (ICDAS) and quality of life related to oral health (GOHAI) will be evaluated.

After inclusion, patients will be randomized between conventional motivation procedures and conventional motivation procedures associated with 3D intra oral procedures.

The investigators hypothesized that the 3D intra oral representations could improve oral hygiene in patients compared with those receiving only a classical motivation procedure. The primary objective is to evaluate if patients instructed to oral hygiene procedures using a representation of their mouth obtained by the use of a intraoral scanner present fewer plaque than the ones instructed without it. This could be achieved by the analysis of plaque control record index in both group.

The secondary objectives are :

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)

盲法说明

The investigator which perform the periodontal examination will be blinded of the motivation procedure

入排标准

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

入选标准

  • consulting the Dental Care Service of the university hospital of Reims
  • presenting gingivitis or periodontal diseases according to the international classification of periodontal diseases (Chicago, 2017)
  • presenting at least 10 pairs of opposing teeth
  • able to perform oral hygiene procedures
  • speaking French
  • who signed the informed consent form
  • affiliated to the French Social Security system
  • Non-inclusion criteria :
  • Patients presenting :
  • a medical history likely to compromise protocol (psychiatric disorders, medical or pharmacological antecedents altering or modifying immune response in last 3 months)
  • pregnancy or breastfeeding
  • eating disorders
  • orthodontic treatments
  • patients under legal protection, trusteeship or guardianship
  • unable to understand auto-questionary
  • Exclusion criteria :
  • Patients presenting :
  • presenting exacerbations signs of periodontal diseases
  • benefiting a professional plaque removal procedure outside of the experimental procedure

排除标准

  • 未提供

结局指标

主要结局

Plaque Control Record Evolution

时间窗: Day 14

Recording the presence of plaque on individual tooth surfaces (mesial, distal, facial, lingual). The plaque is highlighted by a periodontal probe. PCR is calculated according the following formula : PCR = (Number of faces with plaque / Total number of faces) x 100

次要结局

未报告次要终点

研究者

发起方
CHU de Reims
申办方类型
Other
责任方
Sponsor

研究点 (2)

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