Diagnostic Ability of Near Infrared Transillumination Detecting Interproximal Caries as Compared to Conventional Bitewing Radiographs

NCT05362461 | Unknown FDA Device

• 1 other identifier: 19-1142
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Specific Aims

1. 1.To determine the diagnostic efficacy of CariVu and BWX for detecting interproximal carious lesions in primary dentition
2. 2.To determine acceptability and comfort of CariVu and BWX as perceived by patient, parent and independent observer
3. 3.To determine difference in chair-side time required for BWX and CariVu image generation

Conditions

Caries,Dental

Outcome Measures

Primary Outcomes (5)

• Number of carious lesions

  Number of carious lesions will be determined as a numerical value.

  Through study completion, an average of 36 months

• Patient and parental perceived acceptability and comfort

  Exit survey with 3 questions with binary responses will be provided to parents and patients.

  Through study completion, an average of 36 months

• Behavior assessment by an independent observer

  An independent observer (dental assistant) who is masked for the hypothesis of the study will be given a similar questionnaire to evaluate patient behavior using standard behavior assessment scales. Score will be assessed on Frankl Score Behavior Scale. Frankl Scoring is as follows: Frankl 1 Definitively Negative Refusal of treatment, forceful crying, fearfulness, or any other overt evidence of extreme negativism Frankl 2 Negative Reluctance to accept treatment, uncooperativeness, some evidence of negative attitude but not pronounced (sullen, withdrawn) Frankl 3 Positive Acceptance of treatment; cautious behavior at times; willingness to comply with the dentist, at times with reservation, but patient follows the dentist's directions cooperatively Frankl 4 Definitively Positive Definitely positive. Good rapport with the dentist; interest in the dental procedures, laugher and enjoyment

  Through study completion, an average of 36 months

• Time required for generation of either images (CariVu and BWX)

  Both CariVu and BWX images will be taken for routine diagnosis (not an intervention as both images are taken as routine procedures during dental visit). Time to take images will be measured in seconds.

  Through study completion, an average of 36 months

• Depth of carious lesion

  Depth will be measured on a 0-4 point ordinal scale. This scale is as follows: 0- No presence of lesion 1. Caries lesion visible in enamel 2. Caries lesion visible in enamel with single point contact to the dentino-enamel junction 3. Caries lesion visible in enamel extensive contact to the dentino-enamel junction 4. Caries lesion visible in enamel and dentin

  Through study completion, average of 36 months

Study Arms (2)

Bitewing first, CariVu second

Bitewing images will be taken first. CariVu images will be taken second.

Diagnostic Test: Near Infrared Transillumination

CariVu first, Bitewing second

CariVu images will be taken first. CariVu images will be taken second.

Diagnostic Test: Near Infrared Transillumination

Interventions

Near Infrared Transillumination DIAGNOSTIC_TEST

Caries imaging detection technology.

Also known as: CariVu, NIRT

Bitewing first, CariVu second; CariVu first, Bitewing second

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children's Hospital Colorado Dental Clinic Patients that meet the above eligibility criteria

You may qualify if:

• Pediatric patients from 5-9 years of age
• Justification for this age range: Patients younger than 5 years may have open contacts between primary molars.
• Patients more than 9 years may have advanced root resorption and primary teeth might be at advanced stages of exfoliation
• Patients with American Society of Anesthesiologists classification (ASA)-I or II category (medically healthy)
• Parent or legal guardian should consent BWX \[per American Academy of Pediatric Dentistry (AAPD) guidelines\] and CariVu ™ (Dexis) imaging to be completed during same visit
• All selected patients should be in primary or mixed dentition stage with well-established contacts between posterior teeth
• Patient with Frankl behavior assessment score of 3 ("positive") or 4 ("definitely-positive")
• Patient and parent speaking English or Spanish as their preferred language Justification for language: Language barriers may pose challenges to behavior management in pediatric dental patient and thereby reducing the acceptability of dental treatment (confounding factor).

You may not qualify if:

• Patients with ASA III or IV (medically complex or special health care needs patient)
• Patients with open contacts between teeth or missing teeth
• Patients who do not need conventional bitewing radiographs per AAPD guidelines
• Patient with Frankl behavior assessment score of 1 ("definitely negative") or 2 ("negative")

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Children's Hospital Colorado: collaborator

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80011, United States

RECRUITING

Related Publications (18)

• Puranik CP, B.H., Preisser J, Zandona AF., Retrospective longitudinal observation of caries around restorations by quantitative light-induced fluorescence. J Pediatr Dent 2016. 4: p. 66-71.

  BACKGROUND

• Dean, J.A., D.R. Avery, and R.E. McDonald, McDonald and Avery's dentistry for the child and adolescent. Tenth edition. ed. 2016, St. Louis, Missouri: Elsevier. xix, 700 pages.

  BACKGROUND

• Berg SC, Stahl JM, Lien W, Slack CM, Vandewalle KS. A clinical study comparing digital radiography and near-infrared transillumination in caries detection. J Esthet Restor Dent. 2018 Jan;30(1):39-44. doi: 10.1111/jerd.12346. Epub 2017 Nov 24.

  PMID: 29171167 RESULT

• Kraljevic I, Filippi C, Filippi A. Risk indicators of early childhood caries (ECC) in children with high treatment needs. Swiss Dent J. 2017 May 15;127(5):398-410. doi: 10.61872/sdj-2017-05-268. English, German.

  PMID: 28639687 RESULT

• Gray-Burrows KA, Day PF, Marshman Z, Aliakbari E, Prady SL, McEachan RR. Using intervention mapping to develop a home-based parental-supervised toothbrushing intervention for young children. Implement Sci. 2016 May 6;11:61. doi: 10.1186/s13012-016-0416-4.

  PMID: 27153832 RESULT

• Lederer A, Kunzelmann KH, Heck K, Hickel R, Litzenburger F. In vitro validation of near-infrared transillumination at 780 nm for the detection of caries on proximal surfaces. Clin Oral Investig. 2019 Nov;23(11):3933-3940. doi: 10.1007/s00784-019-02824-0. Epub 2019 Jan 28.

  PMID: 30693402 RESULT

• Simon JC, Darling CL, Fried D. Assessment of cavitation in artificial approximal dental lesions with near-IR imaging. Proc SPIE Int Soc Opt Eng. 2017 Jan 28;10044:1004407. doi: 10.1117/12.2256701. Epub 2017 Feb 8.

  PMID: 28626283 RESULT

• Lederer A, Kunzelmann KH, Hickel R, Litzenburger F. Transillumination and HDR Imaging for Proximal Caries Detection. J Dent Res. 2018 Jul;97(7):844-849. doi: 10.1177/0022034518759957. Epub 2018 Feb 26.

  PMID: 29481761 RESULT

• Baltacioglu IH, Orhan K. Comparison of diagnostic methods for early interproximal caries detection with near-infrared light transillumination: an in vivo study. BMC Oral Health. 2017 Nov 16;17(1):130. doi: 10.1186/s12903-017-0421-2.

  PMID: 29145846 RESULT

• Elhennawy K, Askar H, Jost-Brinkmann PG, Reda S, Al-Abdi A, Paris S, Schwendicke F. In vitro performance of the DIAGNOcam for detecting proximal carious lesions adjacent to composite restorations. J Dent. 2018 May;72:39-43. doi: 10.1016/j.jdent.2018.03.002. Epub 2018 Mar 8.

  PMID: 29526667 RESULT

• Abogazalah N, Eckert GJ, Ando M. In vitro performance of near infrared light transillumination at 780-nm and digital radiography for detection of non-cavitated approximal caries. J Dent. 2017 Aug;63:44-50. doi: 10.1016/j.jdent.2017.05.018. Epub 2017 May 27.

  PMID: 28559050 RESULT

• Schaefer G, Pitchika V, Litzenburger F, Hickel R, Kuhnisch J. Evaluation of occlusal caries detection and assessment by visual inspection, digital bitewing radiography and near-infrared light transillumination. Clin Oral Investig. 2018 Sep;22(7):2431-2438. doi: 10.1007/s00784-018-2512-0. Epub 2018 Jun 18.

  PMID: 29915930 RESULT

• American Academy of Pediatric Dentistry. Ad Hoc Committee on Pedodontic Radiology. Guideline on prescribing dental radiographs for infants, children, adolescents, and persons with special health care needs. Pediatr Dent. 2012 Sep-Oct;34(5):189-91. No abstract available.

  PMID: 23211908 RESULT

• Ozkan G, Guzel KGU. Clinical evaluation of near-infrared light transillumination in approximal dentin caries detection. Lasers Med Sci. 2017 Aug;32(6):1417-1422. doi: 10.1007/s10103-017-2265-z. Epub 2017 Jun 26.

  PMID: 28653255 RESULT

• Meyer BD, Lee JY, Casey MW. Dental Treatment and Expenditures Under General Anesthesia Among Medicaid-Enrolled Children in North Carolina. Pediatr Dent. 2017 Nov 1;39(7):439-444.

  PMID: 29335049 RESULT

• Basir L, Rasteh B, Montazeri A, Araban M. Four-level evaluation of health promotion intervention for preventing early childhood caries: a randomized controlled trial. BMC Public Health. 2017 Oct 2;17(1):767. doi: 10.1186/s12889-017-4783-9.

  PMID: 28969655 RESULT

• Abdelaziz M, Krejci I, Perneger T, Feilzer A, Vazquez L. Near infrared transillumination compared with radiography to detect and monitor proximal caries: A clinical retrospective study. J Dent. 2018 Mar;70:40-45. doi: 10.1016/j.jdent.2017.12.008. Epub 2017 Dec 16.

  PMID: 29258850 RESULT

• Simon JC, Curtis DA, Darling CL, Fried D. Multispectral near-infrared reflectance and transillumination imaging of occlusal carious lesions: Variation in lesion contrast with lesion depth. Proc SPIE Int Soc Opt Eng. 2018 Jan-Feb;10473:1047305. doi: 10.1117/12.2296013. Epub 2018 Feb 8.

  PMID: 29497229 RESULT

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Chaitanya Puranik, BDS, MS, M.Dent.Sci, PhD

CONTACT

(720) 777-2719; chaitanya.puranik@childrenscolorado.org

Nicholas DeMeo, D.M.D.

CONTACT

720-777-6788; nicholas.demeo@childrenscolorado.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: May 5, 2022
• Study Start: October 31, 2022
• Primary Completion: December 31, 2022
• Study Completion: January 31, 2023
• Last Updated: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)