3D Scanning and Transillumination vs Conventional Examination to Assess Caries Progression, Stability or Regression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- 5th Scanner caries score
研究概览
简要总结
The objective of this study is to investigate whether the 3D scanner and accompanying software, as well as the transillumination method, can identify changes in primary caries lesions in caries-active patients, where selected lesions achieve a higher degree of plaque control than others over an 8-month period.
The working hypothesis of this study is that the two methods, scanning and transillumination, are as good as the traditional method (clinical examination complemented by radiographs) to assess whether caries lesions are progressing, stable or regressing. Progression, stability or regression of selected caries lesions are thus the endpoint, and the rationale is to investigate whether more objective measures can replace/supplement a subjective method to assess progression, stability or regression of caries lesions.
详细描述
Caries is a non-infectious disease of the hard tissues of the teeth that occurs with very high prevalence around the world. The aetiology and pathogenesis of the disease are well understood. Bacterial accumulation on the teeth (dental plaque) concomitant with the ingestion of fermentable carbohydrates promotes acid production deep within the plaque, which progressively demineralizes the underlying hard dental tissue. Caries thus involves mineral loss from the first crystal disintegrating (not clinically identifiable) through gradually increased demineralization, with the mineral loss being identified early by the tooth tissue changing colour, through the physical appearance of a fracture (cavity) in the tooth, to the complete damage of the tooth. Demineralization can be halted or controlled by daily brushing with fluoride toothpaste, provided that brushing, possibly supplemented with flossing, is carried out as demonstrated by dentists or dental hygienists. Adding professional cleaning, i.e. plaque removal with rotary brushes and flossing and performed by dentists/ dental hygienists or clinic assistants, e.g. once a month, can ensure that the lesion is stopped if daily home dental care is not optimal. If caries has occurred, it can be treated non-operatively or surgically, complemented by risk-related initiatives.
Caries can develop in relation to previously placed fillings. This is referred to as secondary caries. In contrast, the term primary caries is used for caries located on unfilled/restored areas of the tooth or its root surfaces. Whether primary or secondary, caries lesions' severity is classified as superficial, moderate or extensive. The last two diagnoses usually require operative treatment, i.e. a filling, or root canal treatment or extraction.
Caries is detected and diagnosed using a number of methods, the most common being a clinical visual/tactile examination of the teeth, complemented by radiographs. However, this method is highly subjective, and thus with large variation among dentists and dental hygienists, resulting in different treatment strategie. In addition, radiographs lack sensitivity in terms of detection of the initial caries lesions.
Researchers have therefore developed various devices and methods for a more objective modulation of mineral loss, including monitoring of individual caries lesions. Perhaps best known is the QLF (Quantitative Light Fluorescence) system, which uses fluorescence measurements of the tooth's response to demineralization. The latest technology using fluorescence for caries detection and classification is the intraoral 3D scanner with the integrated automated caries registration system, which has been developed and now for a few years has been tested in both in vitro and in vivo studies at the Department of Odontology of the University of Copenhagen (OI).
The technique is based on the fact that healthy and demineralized tooth tissue absorbs the blue-violet light (wavelength ~415 nm) and emits back fluorescent light with different light intensities, from bright green to brownish to red. In terms of detection and classification of caries lesions on occlusal surfaces, the scanner has overall a better reproducibility and a comparable accuracy expressed through sensitivity and specificity compared to a combination of the clinical and radiological examination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medically healthy young adult patients (18-30 years old) where individuals must have ≥ 20 teeth.
- •Two or more active caries lesions
排除标准
- •Patients with impaired salivary secretion
- •Patients with chronic medical diseases.
结局指标
主要结局
5th Scanner caries score
时间窗: 8 months after baseline
Caries score registered using the intraoral scanner and the accompanying software (Trios, 3Shape TRIOS A/S, Denmark) which will provide an automated caries score. Scale used: 0 (sound surfaces), 1. (initial caries lesions in enamel or into the outer third of dentin), 2. (moderate - extensive caries lesions located into the middle - inner third of dentin).
1st Scanner caries score
时间窗: Baseline
Caries score registered using the intraoral scanner and the accompanying software (Trios, 3Shape TRIOS A/S, Denmark) which will provide an automated caries score. Scale used: 0 (sound surfaces), 1. (initial caries lesions in enamel or into the outer third of dentin), 2. (moderate - extensive caries lesions located into the middle - inner third of dentin).
2nd Caries activity assessment score
时间窗: 1.5 months after baseline
The activity of the clinically identified caries lesions (active/arrested) will be based on: Localisation of the lesion (No plaque stagnation area = 0, Plaque stagnation area = 1); Colour of the lesion (Brownish = 0; Whitish = 1); Feeling with probe (Lesion Smooth = 0; Lesion Rough = 1); No breakdown/breakdown on enamel surface: (No breakdown, or breakdown with smooth border area = 0; Breakdown with rough border area = 1); In case of gingival or proximal lesions (Healthy gingiva = 0; Bleeding on probing = 1). Arrested lesions total score ≤ 2 points; Active lesions total score \> 2 points.
1st Clinical gingiva score
时间窗: Baseline
Clinical gingival index ad modem Løe \& Silness (1963) on selected teeth: 6+, 3+, 1+, +2, +4, +7, 7-,5-, 2-, -1, -3, -6. Clinical gingiva score: 0 (Sound gingiva), 1 (A slight redness of the gingiva, no bleeding when probed), 2 (Bleeding when probed), 3 (Spontaneous bleeding).
2nd Scanner caries score
时间窗: 1.5 months after baseline
Caries score registered using the intraoral scanner and the accompanying software (Trios, 3Shape TRIOS A/S, Denmark) which will provide an automated caries score. Scale used: 0 (sound surfaces), 1. (initial caries lesions in enamel or into the outer third of dentin), 2. (moderate - extensive caries lesions located into the middle - inner third of dentin).
2nd X-ray caries score
时间窗: 8 months after baseline
ICDAS grades caries radiologically as no radiolucency visible=0; radiolucency in outer 1/2 of enamel=1; radiolucency in inner 1/2 of enamel ±enamel dentin border=2; radiolucency in outer 1/3 of dentin=3; radiolucency in middle 1/3 of dentin=4; and radiolucency in inner 1/3 of dentin=5.
3rd Caries activity assessment score
时间窗: 3 months after baseline
The activity of the clinically identified caries lesions (active/arrested) will be based on: Localisation of the lesion (No plaque stagnation area = 0, Plaque stagnation area = 1); Colour of the lesion (Brownish = 0; Whitish = 1); Feeling with probe (Lesion Smooth = 0; Lesion Rough = 1); No breakdown/breakdown on enamel surface: (No breakdown, or breakdown with smooth border area = 0; Breakdown with rough border area = 1); In case of gingival or proximal lesions (Healthy gingiva = 0; Bleeding on probing = 1). Arrested lesions total score ≤ 2 points; Active lesions total score \> 2 points.
5th Clinical plaque score
时间窗: 8 months after baseline
Clinical plaque index ad modem Løe \& Silness (1963) on selected teeth: 6+, 3+, 1+, +2, +4, +7, 7-,5-, 2-, -1, -3, -6. Clinical plaque score: 0 (No plaque visible), 1 (A film of plaque visible when using the probe), 2 (Moderate plaque accumulation that can be seen with the naked eye), 3 (An extensive plaque accumulation).
3rd Clinical gingiva score
时间窗: 3 months after baseline
Clinical gingival index ad modem Løe \& Silness (1963) on selected teeth: 6+, 3+, 1+, +2, +4, +7, 7-,5-, 2-, -1, -3, -6. Clinical gingiva score: 0 (Sound gingiva), 1 (A slight redness of the gingiva, no bleeding when probed), 2 (Bleeding when probed), 3 (Spontaneous bleeding).
5th Clinical gingiva score
时间窗: 8 months after baseline
Clinical gingival index ad modem Løe \& Silness (1963) on selected teeth: 6+, 3+, 1+, +2, +4, +7, 7-,5-, 2-, -1, -3, -6. Clinical gingiva score: 0 (Sound gingiva), 1 (A slight redness of the gingiva, no bleeding when probed), 2 (Bleeding when probed), 3 (Spontaneous bleeding).
3rd Scanner caries score
时间窗: 3 months after baseline
Caries score registered using the intraoral scanner and the accompanying software (Trios, 3Shape TRIOS A/S, Denmark) which will provide an automated caries score. Scale used: 0 (sound surfaces), 1. (initial caries lesions in enamel or into the outer third of dentin), 2. (moderate - extensive caries lesions located into the middle - inner third of dentin).
1st Clinical ICDAS score
时间窗: Baseline
ICDAS registration graded as 0 = sound, brownish lesion \< 1 mm = 1b, brownish lesion ≥ 1mm = 2b, whitish lesion after drying = 1w, whitish lesion without drying = 2w, fracture limited to enamel = 3, shadowing = 4, fracture exposing dentin but fracture less than ½ of extent of surface = 5, 6 as 5 but fracture ≥ ½ of extent of surface.
2nd Clinical ICDAS score
时间窗: 1.5 months after baseline
ICDAS registration graded as 0 = sound, brownish lesion \< 1 mm = 1b, brownish lesion ≥ 1mm = 2b, whitish lesion after drying = 1w, whitish lesion without drying = 2w, fracture limited to enamel = 3, shadowing = 4, fracture exposing dentin but fracture less than ½ of extent of surface = 5, 6 as 5 but fracture ≥ ½ of extent of surface.
5th Clinical ICDAS score
时间窗: 8 months after baseline
ICDAS registration graded as 0 = sound, brownish lesion \< 1 mm = 1b, brownish lesion ≥ 1mm = 2b, whitish lesion after drying = 1w, whitish lesion without drying = 2w, fracture limited to enamel = 3, shadowing = 4, fracture exposing dentin but fracture less than ½ of extent of surface = 5, 6 as 5 but fracture ≥ ½ of extent of surface.
1st Caries activity assessment score
时间窗: Baseline
The activity of the clinically identified caries lesions (active/arrested) will be based on: Localisation of the lesion (No plaque stagnation area = 0, Plaque stagnation area = 1); Colour of the lesion (Brownish = 0; Whitish = 1); Feeling with probe (Lesion Smooth = 0; Lesion Rough = 1); No breakdown/breakdown on enamel surface: (No breakdown, or breakdown with smooth border area = 0; Breakdown with rough border area = 1); In case of gingival or proximal lesions (Healthy gingiva = 0; Bleeding on probing = 1). Arrested lesions total score ≤ 2 points; Active lesions total score \> 2 points.
4th Caries activity assessment score
时间窗: 6 months after baseline
The activity of the clinically identified caries lesions (active/arrested) will be based on: Localisation of the lesion (No plaque stagnation area = 0, Plaque stagnation area = 1); Colour of the lesion (Brownish = 0; Whitish = 1); Feeling with probe (Lesion Smooth = 0; Lesion Rough = 1); No breakdown/breakdown on enamel surface: (No breakdown, or breakdown with smooth border area = 0; Breakdown with rough border area = 1); In case of gingival or proximal lesions (Healthy gingiva = 0; Bleeding on probing = 1). Arrested lesions total score ≤ 2 points; Active lesions total score \> 2 points.
2nd Clinical gingiva score
时间窗: 1.5 months after baseline
Clinical gingival index ad modem Løe \& Silness (1963) on selected teeth: 6+, 3+, 1+, +2, +4, +7, 7-,5-, 2-, -1, -3, -6. Clinical gingiva score: 0 (Sound gingiva), 1 (A slight redness of the gingiva, no bleeding when probed), 2 (Bleeding when probed), 3 (Spontaneous bleeding).
4th Clinical gingiva score
时间窗: 6 months after baseline
Clinical gingival index ad modem Løe \& Silness (1963) on selected teeth: 6+, 3+, 1+, +2, +4, +7, 7-,5-, 2-, -1, -3, -6. Clinical gingiva score: 0 (Sound gingiva), 1 (A slight redness of the gingiva, no bleeding when probed), 2 (Bleeding when probed), 3 (Spontaneous bleeding).
4th Scanner caries score
时间窗: 6 months after baseline
Caries score registered using the intraoral scanner and the accompanying software (Trios, 3Shape TRIOS A/S, Denmark) which will provide an automated caries score. Scale used: 0 (sound surfaces), 1. (initial caries lesions in enamel or into the outer third of dentin), 2. (moderate - extensive caries lesions located into the middle - inner third of dentin).
1st X-ray caries score
时间窗: Baseline
ICDAS grades caries radiologically as no radiolucency visible=0; radiolucency in outer 1/2 of enamel=1; radiolucency in inner 1/2 of enamel ±enamel dentin border=2; radiolucency in outer 1/3 of dentin=3; radiolucency in middle 1/3 of dentin=4; and radiolucency in inner 1/3 of dentin=5.
5th Caries activity assessment score
时间窗: 8 months after baseline
The activity of the clinically identified caries lesions (active/arrested) will be based on: Localisation of the lesion (No plaque stagnation area = 0, Plaque stagnation area = 1); Colour of the lesion (Brownish = 0; Whitish = 1); Feeling with probe (Lesion Smooth = 0; Lesion Rough = 1); No breakdown/breakdown on enamel surface: (No breakdown, or breakdown with smooth border area = 0; Breakdown with rough border area = 1); In case of gingival or proximal lesions (Healthy gingiva = 0; Bleeding on probing = 1). Arrested lesions total score ≤ 2 points; Active lesions total score \> 2 points.
3rd Clinical plaque score
时间窗: 3 months after baseline
Clinical plaque index ad modem Løe \& Silness (1963) on selected teeth: 6+, 3+, 1+, +2, +4, +7, 7-,5-, 2-, -1, -3, -6. Clinical plaque score: 0 (No plaque visible), 1 (A film of plaque visible when using the probe), 2 (Moderate plaque accumulation that can be seen with the naked eye), 3 (An extensive plaque accumulation).
4th Clinical plaque score
时间窗: 6 months after baseline
Clinical plaque index ad modem Løe \& Silness (1963) on selected teeth: 6+, 3+, 1+, +2, +4, +7, 7-,5-, 2-, -1, -3, -6. Clinical plaque score: 0 (No plaque visible), 1 (A film of plaque visible when using the probe), 2 (Moderate plaque accumulation that can be seen with the naked eye), 3 (An extensive plaque accumulation).
1st NIR (Near-Infrared) caries score
时间窗: Baseline
Near-Infrared transillumination images of the premolar and molar teeth will be taken in order to examine the proximal and occlusal surfaces for possible caries lesions. (Score as 0-4: 0 (No caries. No dark gray area visible on approximal surface), 1 (Caries limited to enamel without any contact to the DEJ), 2 (Enamel caries with single-point contact to the DEJ), 3 (Enamel caries with extensive contact to the DEJ), 4 (Caries visible in enamel and dentin).
2nd NIR (Near-Infrared) caries score
时间窗: 8 months after baseline
Near-Infrared transillumination images of the premolar and molar teeth will be taken in order to examine the proximal and occlusal surfaces for possible caries lesions. (Score as 0-4: 0 (No caries. No dark gray area visible on approximal surface), 1 (Caries limited to enamel without any contact to the DEJ), 2 (Enamel caries with single-point contact to the DEJ), 3 (Enamel caries with extensive contact to the DEJ), 4 (Caries visible in enamel and dentin).
3rd Clinical ICDAS score
时间窗: 3 months after baseline
ICDAS registration graded as 0 = sound, brownish lesion \< 1 mm = 1b, brownish lesion ≥ 1mm = 2b, whitish lesion after drying = 1w, whitish lesion without drying = 2w, fracture limited to enamel = 3, shadowing = 4, fracture exposing dentin but fracture less than ½ of extent of surface = 5, 6 as 5 but fracture ≥ ½ of extent of surface.
4th Clinical ICDAS score
时间窗: 6 months after baseline
ICDAS registration graded as 0 = sound, brownish lesion \< 1 mm = 1b, brownish lesion ≥ 1mm = 2b, whitish lesion after drying = 1w, whitish lesion without drying = 2w, fracture limited to enamel = 3, shadowing = 4, fracture exposing dentin but fracture less than ½ of extent of surface = 5, 6 as 5 but fracture ≥ ½ of extent of surface.
1st Clinical plaque score
时间窗: Baseline
Clinical plaque index ad modem Løe \& Silness (1963) on selected teeth: 6+, 3+, 1+, +2, +4, +7, 7-,5-, 2-, -1, -3, -6. Clinical plaque score: 0 (No plaque visible), 1 (A film of plaque visible when using the probe), 2 (Moderate plaque accumulation that can be seen with the naked eye), 3 (An extensive plaque accumulation).
2nd Clinical plaque score
时间窗: 1.5 months after baseline
Clinical plaque index ad modem Løe \& Silness (1963) on selected teeth: 6+, 3+, 1+, +2, +4, +7, 7-,5-, 2-, -1, -3, -6. Clinical plaque score: 0 (No plaque visible), 1 (A film of plaque visible when using the probe), 2 (Moderate plaque accumulation that can be seen with the naked eye), 3 (An extensive plaque accumulation).
次要结局
未报告次要终点