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临床试验/NCT03439969
NCT03439969已完成不适用

The Whole is Greater Than the Sum of Its Parts. "A 8-month Randomised Controlled Trial on the Use of Intra-oral Camera and Text Messages on Gingivitis Control"

University of Lisbon0 个研究点目标入组 233 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
233
主要终点
Change from BOMP (Bleeding on Marginal Probing) at 4 & 8 months

研究概览

简要总结

To investigate the effects of using an intra-oral camera (IOC) during supportive periodontal therapy, and oral hygiene mobile text messages (SMS) between appointments on clinical, behavioral and psychological parameters of patients with gingivitis.

详细描述

Dental hygiene behaviours are of paramount importance for controlling gingival health. There is evidence on the use of IOC and of text messages in boosting motivation, sustainability and clinical efficacy of dental hygiene behaviors. Orchestrating these two technologies is expected to create a coaction effect which could improve behavior change interventions, but the effectiveness of such strategy needs to be inspected.

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 researcher was blind to the patients

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

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

排除标准

  • periodontitis (pockets >3), smoking, orthodontics, pregnancy removable partial dentures

研究组 & 干预措施

Control

No Intervention

Dental appointment, one hour and included activities that are normally part of a SPT (Suportive Periodontal Treatment) consultation, as well as specific behavior change techniques, such as the use of reinforcement, goal-setting and feedback 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 and Text Messages were not used.

Intra Oral Camera

Experimental

Dental appointment, one hour and included activities that are normally part of a SPT consultation, as well as specific behavior change techniques, such as the use of reinforcement, goal-setting and feedback. 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: Intra Oral Camera (Device)

Mobile Text Messages

Experimental

Dental appointment, one hour and included activities that are normally part of a SPT consultation, as well as specific behavior change techniques, such as the use of reinforcement, goal-setting and feedback.. Participants in the SMS group further received a total of 16 messages (SMS). One per week.

干预措施: Mobile Text Messages (Device)

Intra Oral Camera and Text Messages

Experimental

Dental appointment, one hour and included activities that are normally part of a SPT consultation, as well as specific behavior change techniques, such as the use of reinforcement, goal-setting and feedback. 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.Participants also received SMS a total of 16 messages (SMS). One per week.

干预措施: Mobile Text Messages (Device)

Intra Oral Camera and Text Messages

Experimental

Dental appointment, one hour and included activities that are normally part of a SPT consultation, as well as specific behavior change techniques, such as the use of reinforcement, goal-setting and feedback. 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.Participants also received SMS a total of 16 messages (SMS). One per week.

干预措施: Intra Oral Camera (Device)

结局指标

主要结局

Change from BOMP (Bleeding on Marginal Probing) at 4 & 8 months

时间窗: Baseline, 4 months & 8 months

Gingival bleeding Index

次要结局

  • HAPA (Health Action Process Approach) behavioral variables questionnaire.(Baseline, 4 & 8 months.)
  • SMS (Short Messages Service) text messages opinion questionnaire(At 4 months.)
  • Intra Oral Camera opinion questionnaire(At 4 and 8 months.)
  • Self-report Dental Hygiene Behaviors questionnaire.(Baseline, 4 and 8 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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