3D Scanning and Transillumination vs Conventional Examination to Assess Caries Progression, Stability or Regression

NCT05409625 | Completed

• 1 other identifier: Protocol MKR
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Caries

Keywords

3D Scanner; Fluorescence; Transillumination; Dental Caries; Intraoral Scanner

Outcome Measures

Primary Outcomes (29)

• 1st Scanner caries score

  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).

  Baseline

• 2nd Scanner caries score

  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).

  1.5 months after baseline

• 3rd Scanner caries score

  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).

  3 months after baseline

• 4th Scanner caries score

  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).

  6 months after baseline

• 5th Scanner caries score

  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).

  8 months after baseline

• 1st NIR (Near-Infrared) caries score

  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).

  Baseline

• 2nd NIR (Near-Infrared) caries score

  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).

  8 months after baseline

• 1st X-ray caries score

  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.

  Baseline

• 2nd X-ray caries score

  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.

  8 months after baseline

• 1st Clinical ICDAS score

  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.

  Baseline

• 2nd Clinical ICDAS score

  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.

  1.5 months after baseline

• 3rd Clinical ICDAS score

  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.

  3 months after baseline

• 4th Clinical ICDAS score

  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.

  6 months after baseline

• 5th Clinical ICDAS score

  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.

  8 months after baseline

• 1st Caries activity assessment score

  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.

  Baseline

• 2nd Caries activity assessment score

  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.

  1.5 months after baseline

• 3rd Caries activity assessment score

  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.

  3 months after baseline

• 4th Caries activity assessment score

  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.

  6 months after baseline

• 5th Caries activity assessment score

  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.

  8 months after baseline

• 1st Clinical plaque score

  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).

  Baseline

• 2nd Clinical plaque score

  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).

  1.5 months after baseline

• 3rd Clinical plaque score

  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).

  3 months after baseline

• 4th Clinical plaque score

  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).

  6 months after baseline

• 5th Clinical plaque score

  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).

  8 months after baseline

• 1st Clinical gingiva score

  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).

  Baseline

• 2nd Clinical gingiva score

  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).

  1.5 months after baseline

• 3rd Clinical gingiva score

  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).

  3 months after baseline

• 4th Clinical gingiva score

  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).

  6 months after baseline

• 5th Clinical gingiva score

  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).

  8 months after baseline

Study Arms (1)

Young adults

EXPERIMENTAL

Participants aged between 18 and 30 years old without chronic diseases but with two caries lesions or more

Device: Intraoral Scanner (TRIOS 4, 3Shape TRIOS A/S, Copenhagen, Denmark); Device: Intraoral camera (DIAGNOcam, KaVo, Biberach, Germany, software version 3.0.1/2.9.1); Device: X-ray device (X-ray device SOREDEX, MINRAY®; Image plates VistaScan; Image plate scanner VistaScan Mini View, Dürr Dental); Procedure: Oral cleaning

Interventions

Intraoral Scanner (TRIOS 4, 3Shape TRIOS A/S, Copenhagen, Denmark) DEVICE

Intraoral scanner which is able to generate a 3D-model of the teeth and is being used for caries detection.

Young adults

Intraoral camera (DIAGNOcam, KaVo, Biberach, Germany, software version 3.0.1/2.9.1) DEVICE

Intraoral camera used for caries detection in the occlusal and proximal surfaces.

Young adults

X-ray device (X-ray device SOREDEX, MINRAY®; Image plates VistaScan; Image plate scanner VistaScan Mini View, Dürr Dental) DEVICE

X-ray device used for caries detection. Two radiographs (bitewings) are taken, one in each side.

Young adults

Oral cleaning PROCEDURE

Removal of tartar and plaque. Tartar removal done at baseline and the fifth visit, but only on selected teeth at the second, third and fourth visit. Regular cleaning with a toothbrush done at all visits.

Young adults

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Medically healthy young adult patients (18-30 years old) where individuals must have ≥ 20 teeth.
• Two or more active caries lesions

You may not qualify if:

• Patients with impaired salivary secretion
• Patients with chronic medical diseases.

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

Institute of Odontology, University of Copenhagen

Copenhagen, 2200, Denmark

Location

Related Publications (7)

• Michou S, Benetti AR, Vannahme C, Hermannsson PG, Bakhshandeh A, Ekstrand KR. Development of a Fluorescence-Based Caries Scoring System for an Intraoral Scanner: An in vitro Study. Caries Res. 2020;54(4):324-335. doi: 10.1159/000509925. Epub 2020 Oct 14.

  PMID: 33053552 BACKGROUND

• Kassebaum NJ, Bernabe E, Dahiya M, Bhandari B, Murray CJ, Marcenes W. Global burden of untreated caries: a systematic review and metaregression. J Dent Res. 2015 May;94(5):650-8. doi: 10.1177/0022034515573272. Epub 2015 Mar 4.

  PMID: 25740856 BACKGROUND

• Pitts NB, Zero DT, Marsh PD, Ekstrand K, Weintraub JA, Ramos-Gomez F, Tagami J, Twetman S, Tsakos G, Ismail A. Dental caries. Nat Rev Dis Primers. 2017 May 25;3:17030. doi: 10.1038/nrdp.2017.30.

  PMID: 28540937 BACKGROUND

• Bellini HT, Arneberg P, von der Fehr FR. Oral hygiene and caries. A review. Acta Odontol Scand. 1981;39(5):257-65. doi: 10.3109/00016358109162287.

  PMID: 7039213 BACKGROUND

• Lussi A, Hibst R, Paulus R. DIAGNOdent: an optical method for caries detection. J Dent Res. 2004;83 Spec No C:C80-3. doi: 10.1177/154405910408301s16.

  PMID: 15286128 BACKGROUND

• de Josselin de Jong E, Sundstrom F, Westerling H, Tranaeus S, ten Bosch JJ, Angmar-Mansson B. A new method for in vivo quantification of changes in initial enamel caries with laser fluorescence. Caries Res. 1995;29(1):2-7. doi: 10.1159/000262032.

  PMID: 7867045 BACKGROUND

• LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.

  PMID: 14121956 BACKGROUND

Related Links

• Intraoral scanner featuring transillumination for proximal caries detection. An in vitro validation study on permanent posterior teeth

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Kim R. Ekstrand, ph.d

  Institute of Odontology, University of Copenhagen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: June 8, 2022
• Study Start: October 15, 2021
• Primary Completion: September 19, 2022
• Study Completion: September 19, 2022
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)