Trial Outcomes & Findings for Validation of Near-infrared Light Transillumination for Interproximal Enamel Caries Detection (NCT NCT02657538)

Results Overview

The geometrical shape of caries lesions is displayed with the near infrared transillumination method. These shapes are classified as: code 0: no lesion visible; code 1: first visible signs in enamel; code 2: established, clear visible signs in enamel; code 3: clear visible in enamel and punctual contact with dentine; code 4: clearly visible and broad contact with dentine Intra- and Interrater-Reliability: Reliability indicates the overall consistency of a measurement. To have a high reliability means in this case, that the diagnostic-tool produces similar results under consistent conditions. The interrater-Reability assesses the degree of agreement between two different raters in their diagnostics on a specific test while the intrarater-Reliability assesses the degree of agreement of a single rater who did a diagnostic-test twice under the same testing conditions. Sensitivity and Specificity: Statistics are not done yet but will be updated when we calculated them

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

35 participants

Primary outcome timeframe

One year

Results posted on

2016-08-18

Participant Flow

Participant milestones

Participant milestones
Measure	All Study Participants 35 participants with either initial caries and/or no carious lesion were included in this study. The participants had to be at least 14 years old, in good health (ASA-Status 1) and they had to give their informed consent.
Overall Study STARTED	35
Overall Study Received Near Infrared Transillumination	35
Overall Study Received Visual Caries Detection + Bite	35
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Validation of Near-infrared Light Transillumination for Interproximal Enamel Caries Detection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=35 Participants 35 participants with either initial caries and/or no carious lesion were included in this study. The participants had to be at least 14 years old, in good health (ASA-Status 1) and they had to give their informed consent.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	27.5 years n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: One year

The geometrical shape of caries lesions is displayed with the near infrared transillumination method. These shapes are classified as: code 0: no lesion visible; code 1: first visible signs in enamel; code 2: established, clear visible signs in enamel; code 3: clear visible in enamel and punctual contact with dentine; code 4: clearly visible and broad contact with dentine Intra- and Interrater-Reliability: Reliability indicates the overall consistency of a measurement. To have a high reliability means in this case, that the diagnostic-tool produces similar results under consistent conditions. The interrater-Reability assesses the degree of agreement between two different raters in their diagnostics on a specific test while the intrarater-Reliability assesses the degree of agreement of a single rater who did a diagnostic-test twice under the same testing conditions. Sensitivity and Specificity: Statistics are not done yet but will be updated when we calculated them

Outcome measures

Outcome measures
Measure	Near Infrared Transillumination n=70 Teeth/ Leasons Near infrared transillumination is applied for initial enamel caries lesion detection. Non invasive caries treatment: If the active comparator does not detect cavitation, fluoride varnish is applied on the test surface. Invasive caries treatment: If the active comparator does detect cavitation, a composite restauration is placed Near-infrared light transillumination device (DIAGNOcam, KaVo, Biberach, Germany)	Visual Caries Detection + BW n=70 Teeth/ Leasons visual caries detection + bite wing radiography (BW): considered as gold standard in caries diagnostics. Non invasive caries treatment: If the active comparator does not detect cavitation, fluoride varnish is applied on the test surface. Invasive caries treatment: If the active comparator does detect cavitation, a composite restauration is placed Visual examination and bitewing (BW) radiography: established diagnostic methods
Caries Extension According to Diagnocam Codes 0-4 (Intra- and Interrater-Reliability, Sensitivity and Specificity) Intra-rater agreement examiner 1	0.68 weighted Kappa Interval 0.39 to 0.7	0.87 weighted Kappa Interval 0.73 to 0.95
Caries Extension According to Diagnocam Codes 0-4 (Intra- and Interrater-Reliability, Sensitivity and Specificity) Intra-rater agreement examiner 2	0.62 weighted Kappa Interval 0.35 to 0.8	0.76 weighted Kappa Interval 0.58 to 0.86
Caries Extension According to Diagnocam Codes 0-4 (Intra- and Interrater-Reliability, Sensitivity and Specificity) Inter-rater agreement	0.42 weighted Kappa Interval 0.13 to 0.42	0.60 weighted Kappa Interval 0.34 to 0.68

SECONDARY outcome

Timeframe: One year

Population: The data were not collected and the Outcome will never be analyzed because of the study population. The participants are all low risk in the analysis of caries, with low amount of gingivitis and good oral hygiene what means that no progression/ change in caries activity will be detectable in any patient. So it doesn't make sense to analyze it.

active lesions: 1; inactive lesions: 0

Outcome measures

Outcome data not reported

Adverse Events

Near Infrared Transillumination

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Visual Caries Detection + BW

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

PD Dr. Klaus Neuhaus

Department of Preventive, Restorative and Pediatric Dentistry, University of Bern

Phone: +41 (0)31 632 49 74

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place