Is DIAGNOcam Comparable to Bitewing Radiographs as a Diagnostic Method for Approximal Caries in Primary Teeth?

NCT03181711 | Completed

• 1 other identifier: DIAGNOcam Malmo U
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

BACKGROUND: To diagnose caries in clinical practice today, a combination of clinical examination with mirror and probe, and in sometimes x-ray images are used. For surfaces in contact with other teeth X-rays (preferably bitewing) are often required. Even though the radiation doses in bitewings are small, it is important to weigh risks against the benefit to avoid unnecessary radiation. There are other methods for diagnosing caries based on different forms of laser light. One such technique is based on the translucency of the teeth. The light is within the near infrared light (NIR) area. A product named DAIGNOcam (diagnostic camera) is using this technology. The light is led in a hand piece held against the tooth. The tooth is illuminated and the caries lesions can be seen like dark spots on a computer monitor screen. The technique is mainly used in adult patients and permanent teeth. However, there is no complete evaluation of how well the technology diagnoses caries in milk teeth. From a radiation hygiene point of view, it is particularly important to reduce the amount of X-rays to young individuals. X-rays are often experienced as difficult by younger children, which leads to poorer diagnostics. It is important to identify early caries in milk teeth as these teeth have thinner enamel and a more "porous" dentin. This may lead to that caries progress much faster thus more difficult to fix. This in turn leads to a risk of toothache and that the damage becomes so extensive that the tooth must be removed. OBJECTIVE: To investigate diagnostic accuracy / precision in caries diagnosis between teeth using DIAGNOcam in milk teeth comparable to caries diagnostics using bitewing x-rays. RESEARCH QUESTIONS:

• Is DIAGNOcam a reliable diagnostic method for diagnosing caries in between teeth (approximal caries) in milk teeth?
• How does child experience caries diagnosing performed with DIAGNOcam compared to X-rays? INVESTIGATION VARIABLES: Caries data are recorded according to the accepted diagnostic method at the surface level. Each examined tooth surface is assessed as either 1) intact; 2) caries only in enamel; 3) caries i dentin; or 4) the surface can not be judged. The same classification is used for X-rays and DIAGNOcam. The children will also be able to rate their experience of the X-ray examination and the DIAGNOcam survey using a Faces pain scale to see if there is any difference in experience between the different methods of investigation.

Conditions

Caries

Keywords

Dental caries; Tooth, deciduous; Children; Radiography/bitewing; diagnostic imaging

Outcome Measures

Primary Outcomes (1)

• number of surfaces with manifest approximal caries lesions

  approximal caries in primary molars registered in radiographs (bitewings) or with DIAGNOcam. Caries lesions clearly visible in dentin.

  measured at the dental examination

Secondary Outcomes (1)

• Children´s perception of pain during examination with radiographs (bitewings) and DIAGNOcam.

  measured at the dental examination

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

50 patients who meet the inclusion criteria are recruited consecutively at the dep of pediatric dentistry, Faculty of Odontology in Malmö. In order to obtain a spread in caries, there are no restraints regarding dental health in the children. It is important to include both children with a lot of caries and children with little or even no caries. No power calculation can be performed as there is no basis for obtaining the size of the study population. However, there are similar studies on other diagnostic methods in which diagnostic reliability was investigated with a study material of 50 patients. Therefore, the study intends to include 50 patients resulting in at least 400 surfaces.

You may qualify if:

• Children aged 4-8
• Radiograph bitewings not older than 3 months
• First and second primary mandibular or maxillary molars present
• Parental consent

You may not qualify if:

• Children not in need of bitewing radiographs
• Children with mineralization disturbances, chronic diseases, functional or psychological disabilities that influence the possibility to participate
• Children who of other reasons have difficulties to participate

Sponsors & Collaborators

• Malmö University: lead

Study Sites (1)

Malmö University

Malmo, SE20506, Sweden

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Susanne I Brogårdh-Roth, Doctor

  Malmö University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: June 4, 2017
• First Posted: June 9, 2017
• Study Start: June 1, 2017
• Primary Completion: January 1, 2022
• Study Completion: April 1, 2022
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)