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

October 31, 2022 updated by: University of Colorado, Denver

Diagnostic Ability of Near Infrared Transillumination (NIRT, CariVu™) for Detecting Interproximal Caries as Compared to Conventional Bitewing Radiographs

Specific Aims

  1. To determine the diagnostic efficacy of CariVu and BWX for detecting interproximal carious lesions in primary dentition

    BWX and CariVu images will be taken in random order. Number and depth of interproximal carious lesions will be determined by two independent examiners using both CariVu images and BWX. Intra- and inter-rater agreement and disagreement will be determined for all the images and radiographs.

  2. To determine acceptability and comfort of CariVu and BWX as perceived by patient, parent and independent observer

    BWX and CariVu images will be taken in a random order and patient and parent will be given a questionnaire to complete as exit survey. The questionnaire will include few questions to determine perceived acceptability and comfort by parent and patient for either methods (CariVu and BWX). 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.

  3. To determine difference in chair-side time required for BWX and CariVu image generation

Time required to generate both, BWX and CariVu images will be documented by an independent observer (dental assistant) who is masked for the hypothesis of the study and will be compared to determine the overall clinical chair-side time required for generating diagnostic images for efficient and accurate treatment planning

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Dental caries is a common disease[1] affecting 621 million children in 2010[2]. Dental caries in children commonly result in dental pain, infection and missed school days [3]. The financial burden of childhood caries is also significant[3] due to involved time during care, transportation and missed work for appointments. Caries development and progression is a multifactorial process which is a preventable by controlling various contributing factors including good oral hygiene practices and healthy diet. Also, with early intervention by a dentist, small caries can be diagnosed early and treated conservatively with reduced financial burden to the patient and their family[4].

Carious lesions are initiated when bacterial biofilm organize onto the tooth surface and produce acid byproducts after metabolism of carbohydrates. This acid causes the degradation of the outer enamel shell of the tooth, eventually progressing into a cavitated lesion. If left untreated, carious lesion can reach the enamel-dentin junction and can spread to increase the lesion size. Thereafter, the carious lesion progress through the dentin and eventually to the dental pulp, causing inflammation and eventual necrosis of the pulp. Caries process can initiate on the occlusal (biting), smooth (buccal or lingual), or interproximal (in between the teeth) surfaces of the tooth. Interproximal surfaces of the teeth are in contact and hence, cannot be visualized clinically during routine dental examinations. Interproximal carious lesions become clinically detectable only when they are advanced with significant to loss of tooth structure[5]. When the interproximal lesions are detected clinically or by radiographs restorative management is warranted. Restorative management of the carious lesions by using various resin-composite materials is an esthetic choice which is often opted by the patient and family. However, secondary caries around the restoration is one of the leading causes of restoration failure[6]. Additionally, in the US, majority of the restorations placed each year are done to replace existing restorations[6]. Large carious lesions with pulpal symptoms may need pulp treatment or dental extractions to remove the source of infection.

In young children (primary or mixed-dentition stages) the contacts between teeth (interproximal) are wider and thicker[7]. Additionally, the outer enamel layer is thin and hence, carious lesions can progress quickly into dentin and eventually into the pulp. Traditionally, screening for interproximal caries in primary and mixed-dentition stages is achieved during routine dental examination by taking BWX. During BWX, a beam of X-ray passes from the cheek side of the tooth through the interproximal contacts and captured on to a film or sensor on the lingual (tongue) side of the tooth. This creates an image representing radiodense and radiolucent areas of the tooth. Radiodense areas have higher mineral content, and radiolucent areas have lower mineral content[5]. When looking at the outer enamel and middle dentin layers of the tooth, radiolucent areas indicate significant demineralization referred to as carious lesions. BWX allow for the evaluation of the interproximal surfaces for any carious lesions, which often cannot be visualized clinically due to closed contacts between the teeth[8, 9]. BWX are successful at detecting initial and well established carious lesions, but have some limitations in ability to detect small incipient (very early) lesions that have not caused enough demineralization to appear radiolucent on imaging [10, 11]. One of the major disadvantage of BWX is the exposure to small doses of radiation, which must be considered when determining the frequency of radiographs[12]. Some parents may have concerns to radiation and may decline intraoral radiographs. This may limit the clinician's ability to determine interproximal carious lesions[3]. Currently, the American Dental Association (ADA) recommends that BWX should be taken at every 6 to 18 months interval depending on caries-risk status of the patient in conformity with the ALARA (as low as reasonably achievable) principle for diagnostic purposes[13]. Despite the radiation concerns from parents, BWX have been a clinical standard of care.

BWX are indicated for children when their posterior molars are in contacts, and the interproximal surfaces could not be viewed clinically during routine dental exam[13]. Anatomically smaller size of the oral cavity and limited behavioral coping skills in children are important considerations while planning BWX. While obtaining BWX, children may have problems such as difficulty biting down on radiographic film holder, minor discomfort from the film touching the floor and roof of their mouth and staying still during exposure. If a child is not able to tolerate the radiographic techniques then radiographs can be undiagnostic[8] in spite of the small radiation exposure[14]. When longer intervals between radiographs are planned due to radiation concerns, caries can go unchecked with findings such as multiple carious lesions in advanced stages at subsequent dental visits. Multiple carious lesions in young children are managed with restorative treatments done under general anesthesia[2] which poses a significant medical risk to the young patients and a significant financial healthcare impact[15]. Hence, preventive and conservative management of caries has been the standard of pediatric dental care. Medical management of caries which includes early caries diagnosis for modifying the caries-initiating factors for a conservative approach has been advocated[16]. Early detection of carious lesions can be managed conservative treatment options such as frequent fluoride varnish applications and changes in oral hygiene and diet[8, 11].

Near Infrared transillumination (NIRT) is a method of caries detection that uses light (instead of X-rays) and a camera to capture information about the density of enamel and dentin at the interproximal contacts thereby eliminating risks of radiation[9]. Specifically, CariVu™ (Dexis) by Kavo, was developed in 2012 in Germany utilizing NIRT at 780nm and capturing the occlusal surface of the transilluminated tooth on a digital image[17]. The device comprises of elastic arms containing the optical fibers and a camera system with the near infrared light source, ranging from 700-1500nm wavelength. The arms approximate the alveolar process of the tooth, allowing transillumination of the crown of the tooth. The arms, unlike BWX films, does not contact the floor or roof of the mouth and therefore, can increase the acceptance by pediatric patients. Demineralized or porous areas of the tooth (indicative of carious lesions) can cause a change in light scatter and appear darker in the image captured by the camera[1, 5]. The CariVu™ (Dexis) image can be evaluated for interproximal caries in a similar manner as BWX for diagnosis and treatment planning.

Previous studies detected superiority of CariVu™ (Dexis) to detect incipient and small carious lesions in permanent dentition [4, 17, 18]. Earlier studies recommended utilizing CariVu™ (Dexis) as an adjunctive technology to BWX when diagnosing caries[1]. Recent studies claimed that CariVu™ (Dexis) could be utilized as a comparable alternative to BWX[9, 11, 17], with benefit of eliminating radiation. CariVu™ (Dexis) can be utilized to detect caries with frequent interproximal imaging[4], for early detection of incipient carious lesions [4, 9, 14, 17]. CariVu™ (Dexis) has been recommended as a safe alternative to ionizing radiation for children[17]. However, due to the anatomical differences in the contacts and interproximal lesions in permanent dentition as compared to primary dentition, it will not be wise to extrapolate inferences from these studies on permanent dentition to primary dentition. There are no studies evaluating the efficacy of CariVu™ (Dexis) in diagnosing interproximal carious lesions in children. Majority of the studies have established the safety of this NIRT technology and hence, utilization of such technology has tremendous potential in pediatric population over BWX due to growing concerns regarding radiation. Additionally, there are no studies evaluating the acceptability of NIRT in children over BWX. As previously discussed, ability to cooperate is an important factor for generating a diagnostic image for caries detection in children. If CariVu™ (Dexis) is tolerated more than BWX in children then, in addition to being safe it can be an effective and efficient tool in pediatric dental practice for diagnostic images to detect carious lesions.

This is a pilot study to determine the efficacy of CariVu™ (Dexis) in diagnosing interproximal carious lesions in children as compared to BWX (standard of care). This study will also evaluate the acceptability of CariVu imaging as compared to BWX in children. The overall chair-side time required for obtaining CariVu images will determine its clinical acceptability. The long-term goal of this study will be to investigate the newer NIRT technology for incorporation in pediatric dental practice as a diagnostic tool for effective reduction of radiation in children with efficient diagnosis of interproximal carious lesions in children with high caries-risk status.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80011
        • Recruiting
        • Children's Hospital Colorado
        • Contact:
          • Nicholas DeMeo, D.M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 5 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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")

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Bitewing first, CariVu second
Bitewing images will be taken first. CariVu images will be taken second.
Diagnostic test: Near Infrared Transillumination
Caries imaging detection technology.
Other Names:
  • CariVu, NIRT
CariVu first, Bitewing second
CariVu images will be taken first. CariVu images will be taken second.
Diagnostic test: Near Infrared Transillumination
Caries imaging detection technology.
Other Names:
  • CariVu, NIRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of carious lesions
Time Frame: Through study completion, an average of 36 months
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
Time Frame: Through study completion, an average of 36 months
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
Time Frame: Through study completion, an average of 36 months

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)
Time Frame: Through study completion, an average of 36 months
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
Time Frame: Through study completion, average of 36 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

Children's Hospital Colorado

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 31, 2022

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

January 31, 2023

Study Registration Dates

First Submitted

January 25, 2022

First Submitted That Met QC Criteria

May 2, 2022

First Posted (Actual)

May 5, 2022

Study Record Updates

Last Update Posted (Actual)

November 1, 2022

Last Update Submitted That Met QC Criteria

October 31, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-1142

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Individual participant data will not be shared with other providers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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