Dental Caries (Diagnosis)NILTNCT07041164
Diagnostic Performance and Children's Acceptance of Near-Infrared Light Transillumination and Bitewing Radiographs for Detecting Proximal Cavitation in Primary Molars of Patients Aged 4 to 10 Years
An observational study of Dental Caries (Diagnosis) and Diagnostic Imaging, run by Sawanya Prutthithaworn at 2 sites in Thailand.
Trial summary
The goal of this observational study is to compare the diagnostic performance of three detection methods for approximal carious lesions in primary molars among pediatric patients aged 4-10 years. The study focuses on children in three age groups: 4-6 years, 6-8 years, and 8-10 years. Read more about this study
- Who is it for?
- Ages 4 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries (Diagnosis), Diagnostic Imaging, Optical Imaging
- What is being tested?
- Bitewing radiograph and Near-infrared light transillumination
- How many people
- 174 participants
- Where
- 2 sitesThailand
- Study dates
- 1 Aug 2025to 30 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Pediatric dental clinic
Who may be able to join
- Healthy Children aged 4-10 years
- Low risk for periodontal disease
- At least one quadrant contains fully erupted, well-aligned adjacent primary molars that are free of restorations, exhibit no clinically visible cavitated caries, demonstrate tooth mobility of grade 2 or less, show no developmental dental anomalies
- Bitewing radiographs show at least one radiolucent lesion in the proximal surface of a primary molar classified as RA2 or RA3 according to the ICDAS II radiographic criteria
Who cannot join
- Root resorption exceeding two-thirds of the root length
- Demonstrate Frankl's behavior rating scale of 1 during either near-infrared light transillumination examination or tooth separation
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sawanya Prutthithaworn, Ph.D. (Dental biomaterials) contact
Thailand2 sites, 2 recruiting
- Not yet recruiting
Dental Hospital, Faculty of Dentistry, Mahidol University (Phayathai Campus)
Bangkok, 10400
Yuwadee Asavanund, Cert. in Pediatric Dentistry, +6622007821, yawadee.asv@mahidol.ac.th
Apiwan Smutkeeree, M.Clin.Dent, apiwan.dan@mahidol.ac.th
- Recruiting
Dental Hospital, Faculty of Dentistry, Mahidol University (Phayathai Campus)
Bangkok, 10400
Yuwadee Asavanund, Cert. in Pediatric Dentistry, +6622007821, yawadee.asv@mahidol.ac.th
Apiwan Smutkeeree, M.Clin.Dent, apiwan.dan@mahidol.ac.th
About this study
The goal of this observational study is to compare the diagnostic performance of three detection methods for approximal carious lesions in primary molars among pediatric patients aged 4-10 years. The study focuses on children in three age groups: 4-6 years, 6-8 years, and 8-10 years. The main questions it aims to answer are:
- Are the sensitivity, specificity, accuracy, and area under the curve (AUC) different across the three diagnostic techniques (bitewing radiography, near-infrared light transillumination, and their combination)?
- Are these diagnostic parameters influenced by patient age?
- Which technique yields the highest level of patient acceptance?
Read more
Researchers will compare the three diagnostic approaches to determine whether age influences diagnostic performance and patient acceptance.
Participants will:
- Be examined using bitewing radiography and near-infrared light transillumination
- Undergo tooth separation for 7 days using orthodontic elastic separators
- Receive clinical examination of the target approximal surface
- Be asked to rate their experience using the Simplified Facial Pain Scale (S-FPS)
Read the detailed description
- 58 carious lesions classified as RA2 and RA3 according to the ICDAS II criteria from three groups of 4-6 years, 6-8 years, and 8-10 years pediatric patients will be examined by near-infrared light transillumination
- The patient acceptance towards bitewing radiograph and near-infrared light transillumination will be evulated by Simplified Facial Pain Scale (S-FPS)
- Diagnostic performance will be assessed by calculating sensitivity, specificity, accuracy, and the area under the curve (AUC)
- The diagnostic efficacy of the caries detection methods will be analyzed using repeated measures ANOVA, and patient acceptance will be assessed using the Chi-square test, with statistical significance set at p < 0.05 and a 95% confidence level.
- Conditions
- Dental Caries (Diagnosis), Diagnostic Imaging, Optical Imaging, Radiographic Image Interpretation, Computer-Assisted, Proximal Dental Caries, Tooth, Deciduous
- Being tested
- Bitewing radiograph, Near-infrared light transillumination
- Keywords
- proximal caries, primary molars, Pediatric Patients, Bitewing Radiography, Near-Infrared Light Transillumination, DIAGNOcam, clinical cavitation, children acceptance, Diagnostic accuracy
- Medical subject headings
- Dental Caries, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bitewing radiographDiagnostic test
Digital radiograph, proximal caries, initial caries
Near-infrared light transilluminationDiagnostic test
DIAGNOcam, proximal caries, initial caries
| Study group | Role | What they receive |
|---|---|---|
| 4-6 years old | Not described Receives: Diagnostic Test: Bitewing radiograph; Diagnostic Test: Near-infrared light transillumination | |
| 6-8 years old | Not described Receives: Diagnostic Test: Bitewing radiograph; Diagnostic Test: Near-infrared light transillumination | |
| 8-10 years old | Not described Receives: Diagnostic Test: Bitewing radiograph; Diagnostic Test: Near-infrared light transillumination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis performance
The diagnostic performance will be described by sensitivity, specificity, accuracy, and the Area Under the Curve (AUC), with values ranging from 0 to 1 for each parameter.
- For sensitivity, zero is equivalent to no true positives detected, and 1 indicates all true positives detected
- For specificity, zero is equivalent to no true negatives detected, and 1 indicates all true negatives detected
- For accuracy, zero is equivalent to all cases misclassified, and 1 indicates all cases correctly classified
- For AUC, zero is equivalent to a perfectly incorrect classification, and 1 indicates a perfectly correct classification
Measured: From enrollment to clinical examination on day 7th
Age-influenced on diagnostic performance
The diagnostic performance for each age group will be described by sensitivity, specificity, accuracy, and the Area Under the Curve (AUC), with values ranging from 0 to 1 for each parameter.
- For sensitivity, zero is equivalent to no true positives detected, and 1 indicates all true positives detected.
- For specificity, zero is equivalent to no true negatives detected, and 1 indicates all true negatives detected.
- For accuracy, zero is equivalent to all cases misclassified, and 1 indicates all cases correctly classified.
- For AUC, zero is equivalent to a perfectly incorrect classification, and 1 indicates a perfectly correct classification.
Measured: From enrollment to clinical examination at day 7th
Secondary outcomes (1)
Children's acceptance
Children's acceptance will be evaluated using the Simplified Facial Pain Scale (S-FPS), which ranges from 0 to 10. The minimum value is 0, representing "no pain", and the maximum value is 10, representing "severe pain".
Measured: From enrollment to examination at day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start1 Aug 2025
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sawanya Prutthithaworn
- Sponsor type
- University, hospital or other
- Collaborators
- Mahidol University
- Responsible party
- Sponsor-investigator, Sawanya Prutthithaworn, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07041164
- Sponsor's protocol ID
- MU-DT/PY-IRB 2025/025.0304
- Acronym
- NILT
- Status last verified
- Sep 2025
- First submitted
- 19 Jun 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: The individual participant data (IPD), as required by the ethical approval granted by MU-DT/PY-IRB, will remain confidential and will not be disclosed. All data will be reported in aggregate form in publications or reports, ensuring that no individual participant can be identified. Any disclosure beyond these conditions will require an amendment to the approved ethical protocol.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance and Children's Acceptance of Near-Infrared Light Transillumination and Bitewing Radiographs for Detecting Proximal Cavitation in Primary Molars of Patients Aged 4 to 10 Years
- ClinicalTrials.gov ID
- NCT07041164
- Acronym / sponsor ID
- NILT / MU-DT/PY-IRB 2025/025.0304
- Conditions
- Dental Caries (Diagnosis), Diagnostic Imaging, Optical Imaging, Radiographic Image Interpretation, Computer-Assisted, Proximal Dental Caries, Tooth, Deciduous
- Keywords
- proximal caries, primary molars, Pediatric Patients, Bitewing Radiography, Near-Infrared Light Transillumination, DIAGNOcam, clinical cavitation, children acceptance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Sawanya PrutthithawornUniversity, hospital or other
- Collaborators
- Mahidol University
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 27 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to compare the diagnostic performance of three detection methods for approximal carious lesions in primary molars among pediatric patients aged 4-10 years. The study focuses on children in three age groups: 4-6 years, 6-8 years, and 8-10 years. The main questions it aims to answer are:
- Are the sensitivity, specificity, accuracy, and area under the curve (AUC) different across the three diagnostic techniques (bitewing radiography, near-infrared light transillumination, and their combination)?
- Are these diagnostic parameters influenced by patient age?
- Which technique yields the highest level of patient acceptance?
Researchers will compare the three diagnostic approaches to determine whether age influences diagnostic performance and patient acceptance.
Participants will:
- Be examined using bitewing radiography and near-infrared light transillumination
- Undergo tooth separation for 7 days using orthodontic elastic separators
- Receive clinical examination of the target approximal surface
- Be asked to rate their experience using the Simplified Facial Pain Scale (S-FPS)
Detailed description
- 58 carious lesions classified as RA2 and RA3 according to the ICDAS II criteria from three groups of 4-6 years, 6-8 years, and 8-10 years pediatric patients will be examined by near-infrared light transillumination
- The patient acceptance towards bitewing radiograph and near-infrared light transillumination will be evulated by Simplified Facial Pain Scale (S-FPS)
- Diagnostic performance will be assessed by calculating sensitivity, specificity, accuracy, and the area under the curve (AUC)
- The diagnostic efficacy of the caries detection methods will be analyzed using repeated measures ANOVA, and patient acceptance will be assessed using the Chi-square test, with statistical significance set at p < 0.05 and a 95% confidence level.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 4-6 years old | – | Diagnostic Test: Bitewing radiograph, Diagnostic Test: Near-infrared light transillumination |
| 6-8 years old | – | Diagnostic Test: Bitewing radiograph, Diagnostic Test: Near-infrared light transillumination |
| 8-10 years old | – | Diagnostic Test: Bitewing radiograph, Diagnostic Test: Near-infrared light transillumination |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Pediatric dental clinic
Key inclusion criteria (4 listed)
- Healthy Children aged 4-10 years
- Low risk for periodontal disease
- At least one quadrant contains fully erupted, well-aligned adjacent primary molars that are free of restorations, exhibit no clinically visible cavitated caries, demonstrate tooth mobility of grade 2 or less, show no developmental dental anomalies
- Bitewing radiographs show at least one radiolucent lesion in the proximal surface of a primary molar classified as RA2 or RA3 according to the ICDAS II radiographic criteria
Key exclusion criteria (2 listed)
- Root resorption exceeding two-thirds of the root length
- Demonstrate Frankl's behavior rating scale of 1 during either near-infrared light transillumination examination or tooth separation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bitewing radiographDigital radiograph, proximal caries, initial caries | Diagnostic test | 4-6 years old, 6-8 years old, 8-10 years old |
| Near-infrared light transilluminationDIAGNOcam, proximal caries, initial caries | Diagnostic test | 4-6 years old, 6-8 years old, 8-10 years old |
Primary outcome
Diagnosis performance
Time frame: From enrollment to clinical examination on day 7th
The diagnostic performance will be described by sensitivity, specificity, accuracy, and the Area Under the Curve (AUC), with values ranging from 0 to 1 for each parameter. * For sensitivity, zero is equivalent to no true positives detected, and 1 indicates all true positives detected * For specificity, zero is equivalent to no true negatives detected, and 1 indicates all true negatives detected * For accuracy, zero is equivalent to all cases misclassified, and 1 indicates all cases correctly classified * For AUC, zero is equivalent to a perfectly incorrect classification, and 1 indicates a perfectly correct classification
Age-influenced on diagnostic performance
Time frame: From enrollment to clinical examination at day 7th
The diagnostic performance for each age group will be described by sensitivity, specificity, accuracy, and the Area Under the Curve (AUC), with values ranging from 0 to 1 for each parameter. * For sensitivity, zero is equivalent to no true positives detected, and 1 indicates all true positives detected. * For specificity, zero is equivalent to no true negatives detected, and 1 indicates all true negatives detected. * For accuracy, zero is equivalent to all cases misclassified, and 1 indicates all cases correctly classified. * For AUC, zero is equivalent to a perfectly incorrect classification, and 1 indicates a perfectly correct classification.
1 secondary outcome
Children's acceptance
Time frame: From enrollment to examination at day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: Undecided. The individual participant data (IPD), as required by the ethical approval granted by MU-DT/PY-IRB, will remain confidential and will not be disclosed. All data will be reported in aggregate form in publications or reports, ensuring that no individual participant can be identified. Any disclosure beyond these conditions will require an amendment to the approved ethical protocol.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sawanya Prutthithaworn, Ph.D. (Dental biomaterials) contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries (Diagnosis) and Diagnostic Imaging, run by Sawanya Prutthithaworn at 2 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sawanya Prutthithaworn, Ph.D. (Dental biomaterials) (+6622007821 ext. 25, sawanya.pru@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis performance (time frame: From enrollment to clinical examination on day 7th). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.