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临床试验/NCT03120559
NCT03120559已完成不适用

Can we Still Save Dental Floss? Improving Dental Floss Adherence and Gingival Health With SMS and an Innovative Floss Holder in a Randomized Controlled Trial

University of Lisbon0 个研究点目标入组 144 人开始时间: 2015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
144
主要终点
Change from BOMP (Bleeding on Marginal Probing) at 4 months

研究概览

简要总结

This study proposes to evaluate the effects of using a new floss holder (GumChuck) and the use of text messages during supportive periodontal therapy, on the psychological, behavioral and clinical parameters of patients with gingivitis, outlined by evidence and a theory-based framework.

详细描述

Despite evidence on the benefits of controlling dental biofilm for preventing gingivitis, patients have difficulty complying. Floss holder devices and SMS may be useful in enhancing both the frequency and effectiveness of dental hygiene behaviors, by increasing patients' motivation and self-regulation efforts, but scarce scientific literature supporting their worth in controlling gingivitis and the underlying psychological processes is currently available.

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
否

入选标准

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

排除标准

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

研究组 & 干预措施

Control

No Intervention

The dental consultation was the same for all the groups.

    • Examination and diagnosis (15 min).
    • Motivation, discussion about desired outcomes and treatment needs followed by instrumentation (scaling, polishing) (30 min).
    • Therapeutic goals, therapeutic strategies, teaching skills (brushing and interproximal control with regular waxed floss at the Control group) and scheduling of the follow-up appointment (15 min).

They were properly organized in accordance with the features of each patient, such as their gingival condition, gingivitis perception, habits and expectancies concerning the treatment. The consultation time was 60 minutes and also included specific behavior change techniques, such as reinforcement, goal-setting, and feedback.

NFH - New Floss Holder

Other

The dental consultation was the same for all the groups. They were properly organized in accordance with the features of each patient, such as their gingival condition, gingivitis perception, habits and expectancies concerning the treatment. The consultation time was 60 minutes and also included specific behavior change techniques, such as reinforcement, goal-setting, and feedback. New Floss Holder - Gum Chucks

干预措施: New Floss Holder - Gum Chucks (Device)

New Floss Holder and Short Messages

Other

The dental consultation was the same for all the groups. They were properly organized in accordance with the features of each patient, such as their gingival condition, gingivitis perception, habits and expectancies concerning the treatment. The Intervention time was 60 minutes and also included behavior change techniques, such as reinforcement, goal-setting, and feedback. Participants in the NFH/SMS group further received a total of 16 messages (SMS).

New Floss Holder - Gum Chucks/SMS

干预措施: New Floss Holder - Gum Chucks/SMS (Device)

结局指标

主要结局

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

时间窗: Baseline & 4 months

Gingival bleeding Index

次要结局

  • SMS opinion questionnaire(4 months)
  • Self-report Dental Hygiene Behaviors questionnaire.(Baseline & 4 months)
  • HAPA behavioral variables questionnaire.(Baseline & 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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