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临床试验/NCT04235010
NCT04235010已完成不适用

Effects of Genius Toothbrushes on Periodontal Status of Patients Undergoing Fixed Orthodontic Treatment

Pamukkale University2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2018年10月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
2
主要终点
Löe and Silness gingival index measurement

研究概览

简要总结

This study evaluates the effects of genius toothbrushes on periodontal status of patients during fixed orthodontic treatment.Half of the patients received manual orthodontic toothbrushes (Oral B Ortho, Procter & Gamble, USA) with V-shaped bristles and rounded ends. The others received genius orthodontic toothbrush (Oral B Genius 8900, Procter & Gamble, USA) with Oral-B CrossAction brush head, Procter & Gamble, USA).

详细描述

Powered (genius) toothbrush with position detection technology provides patient to clean all areas of the mouth during the required time. By connecting phone to the Oral-B App, the genius toothbrush uses facial recognition technology to guide patient's brushing, zone to zone. Pressure control and personalization are another characteristics of these toothbrushes. Pressure sensor alerts patient if the brushing is too hard and helps her/him not to put too much pressure by reducing the speed of brush head. Due to the Bluetooth technology, toothbrushing can be performed more efficiently among orthodontic adolescent patients. In addition, the position detection and timer can be used to control which area is brushed in the mouth and how much total brushing time is continued. The application allows patient to see all the days brushing activity and real-time feedback on brushing habits can be received by this way.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

盲法说明

The examiner who performed clinical periodontal parameters was blinded to group assignment.

入排标准

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

入选标准

  • Permanent dentition with no missing teeth
  • No systemic or severe periodontal problems
  • Indication of non-extraction fixed orthodontic treatment
  • No use of drugs in the past two months
  • Absence of physical problems that prevent brushing
  • Right handedness for brushing
  • Same bracket type (0.022 slot metal, conventional) and ligation technique (wire ligature)
  • Finishing of leveling phase (use of rectangular wires)
  • Initial total score was between 3 and 10 for the labial surface of each tooth according to the modified Silness and Löe plaque index

排除标准

  • Missing teeth
  • Systemic or severe periodontal problem
  • Indication of extraction treatment
  • Use of drugs in the past two months
  • Levelling phase of fixed orthodontic treatment

结局指标

主要结局

Löe and Silness gingival index measurement

时间窗: 4 months

A score from 0 to 3 is given. Grade 0 indicates normal gingiva; grade 1 mild inflammation with no bleeding; grade 2 moderate inflammation, erythema, swelling, bleeding on probing or when pressure applied; grade 3 severe inflammation, severe erythema and swelling, tendency toward spontaneous hemorrhage, some ulceration

Bleeding on probing scores

时间窗: 4 months

A periodontal probe runs along the marginal gingiva at an angle of approximately 60° to the longitudinal axis of the tooth to determine whether probing elicited marginal bleeding (score 1) or not (score 0). The inflammation was recorded as bleeding scores if bleeding occurred within 30 seconds of probing. Bleeding on probing was estimated as a percentage.

Modified Silness and Löe plaque index measurement

时间窗: 4 months

The buccal surface of each tooth is divided into four zones (mesial, distal, gingival and incisal) to the bracket. Each of the four sites of the buccal tooth surface is given a score from 0 to 3, where 0 indicates the absence of plaque; 1 indicates no plaque visible, but an accumulation of soft deposit on a probe when used to clean the surface; 2 indicates a moderate accumulation of soft deposit on the tooth which can be seen with the naked eye; and 3 indicates an abundance of soft matter on the tooth. For the analysis, values are summed to obtain a total score per participant.

次要结局

未报告次要终点

研究者

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

Serpil Cokakoglu

Assistant Professor

Pamukkale University

研究点 (2)

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