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临床试验/NCT02725983
NCT02725983已完成不适用

Psychological, Behavioral and Clinical Effects of Intra Oral Camera: a Randomized Control Trial on Adults With Gingivitis

University of Lisbon0 个研究点目标入组 78 人开始时间: 2014年6月1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
78
主要终点
The gingival condition was assessed using the BOMP (Bleeding on Marginal Probing) index , as described by Van der Weijden et al. (1994).

研究概览

简要总结

Evaluate the effects of using an intra-oral camera (IOC) during supportive periodontal therapy (SPT), on the psychological, behavioral and clinical parameters of patients with gingivitis, outlined by evidence and a theory-based framework.

详细描述

A group of 78 adult patients with gingivitis receiving an SPT was randomized into two groups: IOC and control.

Bleeding on Marginal Probing (BOMP), self-reported dental hygiene behaviors, and psychological determinants of behavior change (outcome expectancies, self-efficacy and planning) and IOC opinion were evaluated one week before or during the consultation and four months later.

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 (Care Provider)

入排标准

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

入选标准

  • •>18 years old.
  • •+ 20 teeth (minimum 5 per quadrant)
  • •BOMP > 0.5

排除标准

  • •periodontitis (pockets >4),
  • •smoking patients
  • •orthodontic patients
  • •1 removable partial denture

研究组 & 干预措施

Intra Oral Camera

Experimental

Dental appointment, one hour and included activities that are normally part of a SPT consultation (Bardet et al. 1999), as well as specific behavior change techniques, such as the use of reinforcement, goal-setting and feedback as described by Newton and Asimakopoulou (2015). Special attention was given to patient communication and words such as 'cleaning' and 'hygiene' were replaced by therapeutic synonyms (e.g. inflamed areas and controlling the inflammation). In this group, the device SOPROCARE® by Acteon was used in the examination and diagnosis and also for the establishment of therapeutic goals, strategies and skills.

干预措施: SPT consultation (Behavioral)

Intra Oral Camera

Experimental

Dental appointment, one hour and included activities that are normally part of a SPT consultation (Bardet et al. 1999), as well as specific behavior change techniques, such as the use of reinforcement, goal-setting and feedback as described by Newton and Asimakopoulou (2015). Special attention was given to patient communication and words such as 'cleaning' and 'hygiene' were replaced by therapeutic synonyms (e.g. inflamed areas and controlling the inflammation). In this group, the device SOPROCARE® by Acteon was used in the examination and diagnosis and also for the establishment of therapeutic goals, strategies and skills.

干预措施: SOPROCARE® (Device)

No Intra Oral camera

Active Comparator

Dental appointment, one hour and included activities that are normally part of a SPT consultation (Bardet et al. 1999), as well as specific behavior change techniques, such as the use of reinforcement, goal-setting and feedback as described by Newton and Asimakopoulou (2015) and considered crucial to the accomplishment of long term behavior change. Moreover, special attention was given to patient communication and words such as 'cleaning' and 'hygiene' were replaced by therapeutic synonyms (e.g. inflamed areas and controlling the inflammation) in order to focus patients´ attention on the varied facets of oral health care and increase their perception of the treatment needs. In this group, the device SOPROCARE® by Acteon was not used.

干预措施: SPT consultation (Behavioral)

结局指标

主要结局

The gingival condition was assessed using the BOMP (Bleeding on Marginal Probing) index , as described by Van der Weijden et al. (1994).

时间窗: Baseline to 4 months

In this index, bleeding is scored during 30 seconds of probing using a 3 point scale from 0 to 2 (0 - no bleeding, 1 - point bleeding, 2 - excess bleeding).

次要结局

  • Dental Hygiene (Flossing and tooth-brushing habits)(Baseline to 4 months)
  • Measuring Health Behavior Change: Health Action Process Approach Model (HAPA, Schwarzer, 2008)(Baseline to 4 months)

研究者

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

Mario Rui Araújo

Master in Health psychology

University of Lisbon

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