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临床试验/NCT05372848
NCT05372848已完成不适用

Clinical Evaluation of an Electric and a Manual Toothbrush in Removal of Dental Plaque by Intraoral Imaging Systems

Marmara University2 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2022年1月3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
30
试验地点
2
主要终点
Plaque index

研究概览

简要总结

The study aimed to evaluate the efficacy of manual and electric toothbrush on dental plaque removal by using various intraoral imaging systems. Thirty healthy individuals using the same type of toothbrush for at least 2 years participated in the study. 12 teeth of each individual, including upper and lower anteriors, were examined. Group 1 including volunteers who used to use manual toothbrushes (MT) started to use an electric toothbrush (ET) and Group 2 including volunteers who used to use an ET and started to use a MT for 1 month with the same daily brushing routines. Following the clinical intraoral examination, plaque (PI) and gingival index (GI) measurements were performed 5 hours after brushing. The GI was evaluated through Sillness&Löe Gingival Index. The PI was evaluated according to Quigley and Hein's Plaque Index criteria and was scored clinically on visual inspection and digital imaging systems including FluoreCam, DSLR Camera, D-Light Pro, Smile Lite MDP, iTero Element Flex. The data was evaluated under p<0.005 significant level.

详细描述

Patient and teeth selection criteria Ten healthy individuals between the ages of 20 and 30 years with no systemic disease, restoration or caries, and whom have the criteria for using the same type of toothbrush for 2 years (15 of them use manual toothbrushes and 15 of them use electric toothbrushes) participated in the study. 12 teeth of each individual, including upper and lower anteriors, were examined. The researchers supplied the volunteers with a manual toothbrush (Oral-B toothbrush Pro Expert Complete, Procter&Gamble, USA), an electronic toothbrush with replacement head (Oral-B Cross Action toothbrush replacement head, Procter&Gamble, USA), and a toothpaste (Oral-B Professional Toothpaste and Enamel Pro Repair Toothpaste, Procter&Gamble, USA).

Changing the Type of Toothbrush The first group (Group 1) includes volunteers who used to use manual toothbrushes and started to use an electric toothbrush for 1 month with the same daily brushing routine. The second group (Group 2) includes volunteers who used to use an electric toothbrush and started to use a manual toothbrush for 1 month with the same daily brushing routines.

Plaque and gingival index measurements Following the clinical intraoral examination of the volunteers in both groups, plaque and gingival index measurements were performed 5 hours after brushing. Regarding the plaque detection, a special 3-tone plaque staining product, Tri Plaque ID gel (GC Corp., Tokyo, Japan), was used to demonstrate the quantity and quality of the plaques on teeth' surfaces. The staining gel was applied onto buccal surfaces of upper and lower anterior teeth. The plaque and gingival indexes were both evaluated initially, 1 week, and 1 month after the toothbrush changes. The plaque index was evaluated according to Quigley and Hein's Plaque Index criteria. The gingival index was evaluated through Sillness & Löe Gingival Index and was scored clinically on visual inspection, digitally on dental photographs and digital imaging systems.

Quigley ve Hein Plaque Index 0 -> No plaque 1 -> Flecks of stain of the gingival margin 2 -> Definitive line of plaque on gingival margin 3 -> Gingival third of surface 4 -> Two-thirds of surface 5 -> Greater then 2/3rd of the surface Sillness & Löe Gingival Index 0 -> Healthy gingiva 1 -> Slight change in color and mild inflammation, no bleeding 2 -> Redness, moderate inflammation, bleeding on probing/pressure 3 -> Marked redness, severe inflammation, spontaneous bleeding Monitorization with intraoral dental photography The stained and unstained photographs of the teeth were taken initially, one week, and one month after the toothbrush changes. A camera (Nikon D7100), a macro lens (Nikon, 105mm VR macro lens), and a TTL dual macro flashlight (Meike MK-MT24N) was used for the DSLR photography. The camera parameters were set to ISO 400, diaphragm f/25, and shutter speed 1/125. A mobile dental photography device, Smile Lite MDP, was also used in combination with a smart phone (iPhone 12 Mini, Apple Inc, CA, USA) as an alternative photography technique. CP filter was used for all the photographs taken with Smart Lite MDP. The photographs with and without CP were taken without calibrating the white balance (WB) in auto white balance (AWB) mode. Additionally, a led curing unit D-Light Pro was used in detection mode in combination with the DSLR camera to enhance the visualization of the stained plaque. ISO was set at 1600 and diaphragm f/11 for photography with the D-Light Pro. The quantity of the plaque on tooth surfaces was scored through the photographic analysis.

Monitorization with digital imaging systems The stained and unstained measurements were performed initially, one week, and one month after the toothbrush changes by using FluoreCam and iTero Flex devices. After the plaque was stained, it was distinguished from healthy enamel tissue in terms of both color and fluorescence properties. FluoreCam device was used as one of the methods to determine the amount of dental plaque visually and numerically in this study. The stained plaque areas were automatically marked and recorded in the FluoreCam software, simultaneously with the visualization of fluorescence images of upper and lower anterior teeth on the screen. Size and intensity values of stained plaque were obtained from FluoreCam software. Size values represent the area of the plaque, meanwhile intensity values demonstrate the amount of mineral loss and were always represented as a negative number. Decreasing values in intensity (e.g., from -15 to -10) signify that the lesion (mineral content) had slightly improved.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Screening
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • using manual or electric toothbrush for at least 2 years

排除标准

  • systemic disease,
  • restoration or caries in anterior teeth

结局指标

主要结局

Plaque index

时间窗: 1 week

Plaque was evaluated according to Quigley and Hein's Plaque Index criteria

intraoral dental photography

时间窗: 1 week

dental plaque was evaluated using a digital camera and mobile dental photography device and scored according to Quigley and Hein's Plaque Index

intraoral scanner

时间窗: 1 week

plaque was evaluated visually using iTero Flex intraoral scanner

Fluorescence assesment

时间窗: 1 week

FluoreCam device is based on fluorescence technology. After dental plaque is stained, it is distinguished from healthy enamel tissue in terms of both color and fluorescence properties. FluoreCam system's software determines the amount of dental plaque visually and quantitatively. The stained plaque areas were automatically marked and recorded in the FluoreCam software, simultaneously with the visualization of fluorescence images of upper and lower anterior teeth on the screen. Size and intesity values of stained plaque were obtained from FluoreCam software.

Gingival index

时间窗: 1 week

Gingival index was evaluated through Sillness\&Löe Gingival Index

次要结局

  • Fluorescence assesment(1 month)
  • intraoral scanner(1 month)
  • intraoral dental photography(1 month)
  • Plaque index(1 month)
  • Gingival index(1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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