Primary Dental CariesNCT07250022
Detection of Residual Caries on Class II Cavity Walls in Primary Teeth Following Atraumatic Restorative Treatment (ART)
A study testing FACE + Caries Detection Dye and FACE + Visual-Tactile Examination in people with Primary Dental Caries, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of this study is to compare the diagnostic agreement and effectiveness of three different methods-Fluorescence-Aided Caries Excavation (FACE), caries detection dye, and clinical observation-in detecting residual caries remaining on cavity walls of primary teeth following Atraumatic Restorative… Read more about this study
- Who is it for?
- Ages 4 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Dental Caries
- What is being tested?
- FACE + Caries Detection Dye and FACE + Visual-Tactile Examination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2025to 15 Feb 2026
- Phase
- Interventional
- 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 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 4-9 years at enrollment
- Healthy children who can cooperate with dental examination
- Multi-surface carious cavities that are asymptomatic (no acute symptoms)
- Written informed consent from parent/guardian and assent from the child
Who cannot join
- Acute dental infection present
- Any systemic disease/condition
- Lack of cooperation during the procedure
- Refusal to participate / informed consent not obtained from parent/guardian and/or assent not obtained from the child
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Canakkale Onsekiz Mart University
Çanakkale, Kepez, 17100
About this study
Official title: Detection of Residual Caries on Class II Cavity Walls in Primary Teeth Following Atraumatic Restorative Treatment (ART): A Comparative Evaluation of Fluorescence-Aided Caries Excavation (FACE), Caries Detection Dye, and Clinical Assessment
The primary aim of this study is to compare the diagnostic agreement and effectiveness of three different methods-Fluorescence-Aided Caries Excavation (FACE), caries detection dye, and clinical observation-in detecting residual caries remaining on cavity walls of primary teeth following Atraumatic Restorative Treatment (ART). Through this comparison, the study seeks to identify the method that provides more reliable and accurate results, thereby contributing to clinical practice by guiding clinicians and supporting the development of strategies to enhance the long-term success of ART.
Read the detailed description
Effective management of dental caries in primary teeth is of great importance for pain relief, infection prevention, and the maintenance of a child's overall health. Atraumatic Restorative Treatment (ART), which is frequently preferred in pediatric patients and in regions with limited resources, is a minimally invasive approach that involves the selective removal of carious tissue using hand instruments instead of rotary tools, followed by restoration of the cavity with glass ionomer cement. This method aims to preserve tooth structure, enhance patient comfort, and reduce pulpal irritation. However, the primary limitation of ART is that caries removal relies on the clinician's visual and tactile assessment. This subjectivity increases the risk of residual caries remaining on the cavity walls, which can negatively affect the success and long-term durability of the restoration. The presence of a larger pulp chamber and thinner dentin structure in primary teeth further exacerbates this risk.
Reliable detection of residual caries is therefore crucial to the success of ART. Nevertheless, traditional methods such as clinical observation and caries detection dyes have notable limitations. Clinical observation is subject to low reproducibility due to its dependence on individual experience and judgment, while caries detection dyes can stain not only infected dentin but also demineralized yet healthy tissue, potentially leading to unnecessary tissue removal and an increased risk of pulp exposure. This outcome contradicts the minimally invasive philosophy of ART. Consequently, the use of more objective and precise techniques, such as Fluorescence-Aided Caries Excavation (FACE), has gained increasing importance for accurate detection of residual caries and improvement of treatment outcomes.
Participants in this study will consist of children aged 4 to 9 years who are medically healthy and capable of cooperating during the examination. Each primary molar will be evaluated in six distinct regions: axial wall, gingival floor, enamel-dentin junction, buccal wall, lingual wall, and pulpal wall. The assessment will be conducted sequentially using three different methods: Fluorescence-Aided Caries Excavation (FACE), caries detection dye (Caries Detector, Kuraray, Okayama, Japan), and clinical observation. The FACE method will be performed in a non-contact manner using the D-light Pro GC device (DT mode, GC Europe NV, Leuven, Belgium). The other two methods will involve visual-tactile examination under standard clinical conditions.
All evaluations will be carried out under identical conditions by two independent observers, and each cavity wall will be recorded as either "caries present" or "caries absent." The collected data will be transferred to the SPSS software for statistical analysis and coded as 1/0 (present/absent). In addition, participants' age, gender, dmft index, tooth location (maxilla/mandible), and tooth type (first or second primary molar) will be documented. These variables will allow for the statistical evaluation of potential demographic and clinical factors associated with the presence of residual caries. After the application of all three diagnostic methods on the same cavity, if any of the techniques indicated the presence of residual caries, the clinician-at their discretion-performed additional excavation to remove the affected tissue before proceeding to the final restoration. All teeth were subsequently restored using high-viscosity glass ionomer cement, in accordance with the ART protocol.
- Conditions
- Primary Dental Caries
- Being tested
- FACE + Caries Detection Dye, FACE + Visual-Tactile Examination
- Keywords
- dentin caries, dental atraumatic restorative treatment, primary teeth, FACE, residual caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FACE + Caries Detection DyeDiagnostic test
Residual caries detection performed using FACE and caries detection dye.
FACE + Visual-Tactile ExaminationDiagnostic test
Residual caries detection performed using FACE and visual-tactile method.
| Study group | Role | What they receive |
|---|---|---|
| FACE + Caries Detection Dye | Active comparator | Not described Receives: Diagnostic Test: FACE + Caries Detection Dye |
| FACE + Visual-Tactile Examination | Active comparator | Not described Receives: Diagnostic Test: FACE + Visual-Tactile Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of residual caries detection accuracy using FACE and caries detector dye versus FACE and visual-tactile examination
Residual caries detection will be performed in two diagnostic arms: (1) FACE combined with caries detector dye and (2) FACE combined with visual-tactile examination. After atraumatic caries removal, the presence or absence of residual caries will be evaluated on six cavity walls (axial, gingival, enamel-dentin junction, buccal, lingual, and pulpal). Diagnostic accuracy will be expressed as sensitivity, specificity, and overall accuracy compared with a reference standard (soft dentin confirmed by tactile evaluation).
Measured: Baseline (immediately after caries removal procedure; single visit; up to 10 minutes; no follow-up required)
Secondary outcomes (4)
Assessment of residual caries detection by visual-tactile examination
Visual-tactile inspection will assess color, hardness, and texture of the dentin surface. Soft or dark dentin areas, or those producing a "catch" when probed, will be considered positive for residual caries.
Measured: Baseline (immediately after caries removal procedure; up to 5 minutes; no follow-up required)
Assessment of residual caries detection by caries detector dye
Caries detector dye (Caries Detector, Kuraray, Japan) will be applied for 10 seconds and rinsed. Areas showing red or pink staining will be classified as residual caries.
Measured: Baseline (immediately after caries removal procedure; up to 10 minutes; no follow-up required)
Assessment of residual caries detection by FACE (Fluorescence-Aided Caries Excavation)
Using the D-Light Pro device (GC Europe), cavity walls will be examined under violet-blue excitation light. Red-orange fluorescence areas will be identified as residual caries; green fluorescence areas will be considered sound dentin.
Measured: Baseline (immediately after caries removal procedure; up to 10 minutes; no follow-up required)
Assessment of residual caries detection rate per cavity wall
For each cavity, residual caries presence (yes/no) will be recorded in six specific regions (axial, gingival, enamel-dentin junction, buccal, lingual, and pulpal). The percentage of positive areas will be calculated for each diagnostic method.
Measured: Baseline (immediately after caries removal procedure; up to 10 minutes; no follow-up required)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start20 Dec 2025
- Primary completion1 Feb 2026 (estimated)
- Study completion15 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Dental CariesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Çanakkale Onsekiz Mart University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burak Carıkcıoglu, Çanakkale Onsekiz Mart University
- Investigators
- Burak Çarıkçıoğlu, Associate Professor, Principal investigator, Çanakkale Onsekiz Mart UniversityHilal Öztürk, Research Assistant, Principal investigator, Çanakkale Onsekiz Mart UniversityİDİL AY ŞİMŞEK, Research Assistant, Principal investigator, Çanakkale Onsekiz Mart University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07250022
- Sponsor's protocol ID
- COMU-BCARIKCIOGLU-2025
- Status last verified
- Jan 2026
- First submitted
- 18 Nov 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Residual Caries on Class II Cavity Walls in Primary Teeth Following Atraumatic Restorative Treatment (ART): A Comparative Evaluation of Fluorescence-Aided Caries Excavation (FACE), Caries Detection Dye, and Clinical Assessment
- ClinicalTrials.gov ID
- NCT07250022
- Acronym / sponsor ID
- COMU-BCARIKCIOGLU-2025
- Conditions
- Primary Dental Caries
- Keywords
- dentin caries, dental atraumatic restorative treatment, primary teeth, FACE, residual caries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Çanakkale Onsekiz Mart UniversityUniversity, hospital or other
- Study start
- 20 Dec 2025 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 15 Feb 2026 (estimated)
- First posted
- 25 Nov 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 primary aim of this study is to compare the diagnostic agreement and effectiveness of three different methods-Fluorescence-Aided Caries Excavation (FACE), caries detection dye, and clinical observation-in detecting residual caries remaining on cavity walls of primary teeth following Atraumatic Restorative Treatment (ART). Through this comparison, the study seeks to identify the method that provides more reliable and accurate results, thereby contributing to clinical practice by guiding clinicians and supporting the development of strategies to enhance the long-term success of ART.
Detailed description
Effective management of dental caries in primary teeth is of great importance for pain relief, infection prevention, and the maintenance of a child's overall health. Atraumatic Restorative Treatment (ART), which is frequently preferred in pediatric patients and in regions with limited resources, is a minimally invasive approach that involves the selective removal of carious tissue using hand instruments instead of rotary tools, followed by restoration of the cavity with glass ionomer cement. This method aims to preserve tooth structure, enhance patient comfort, and reduce pulpal irritation. However, the primary limitation of ART is that caries removal relies on the clinician's visual and tactile assessment. This subjectivity increases the risk of residual caries remaining on the cavity walls, which can negatively affect the success and long-term durability of the restoration. The presence of a larger pulp chamber and thinner dentin structure in primary teeth further exacerbates this risk.
Reliable detection of residual caries is therefore crucial to the success of ART. Nevertheless, traditional methods such as clinical observation and caries detection dyes have notable limitations. Clinical observation is subject to low reproducibility due to its dependence on individual experience and judgment, while caries detection dyes can stain not only infected dentin but also demineralized yet healthy tissue, potentially leading to unnecessary tissue removal and an increased risk of pulp exposure. This outcome contradicts the minimally invasive philosophy of ART. Consequently, the use of more objective and precise techniques, such as Fluorescence-Aided Caries Excavation (FACE), has gained increasing importance for accurate detection of residual caries and improvement of treatment outcomes.
Participants in this study will consist of children aged 4 to 9 years who are medically healthy and capable of cooperating during the examination. Each primary molar will be evaluated in six distinct regions: axial wall, gingival floor, enamel-dentin junction, buccal wall, lingual wall, and pulpal wall. The assessment will be conducted sequentially using three different methods: Fluorescence-Aided Caries Excavation (FACE), caries detection dye (Caries Detector, Kuraray, Okayama, Japan), and clinical observation. The FACE method will be performed in a non-contact manner using the D-light Pro GC device (DT mode, GC Europe NV, Leuven, Belgium). The other two methods will involve visual-tactile examination under standard clinical conditions.
All evaluations will be carried out under identical conditions by two independent observers, and each cavity wall will be recorded as either "caries present" or "caries absent." The collected data will be transferred to the SPSS software for statistical analysis and coded as 1/0 (present/absent). In addition, participants' age, gender, dmft index, tooth location (maxilla/mandible), and tooth type (first or second primary molar) will be documented. These variables will allow for the statistical evaluation of potential demographic and clinical factors associated with the presence of residual caries. After the application of all three diagnostic methods on the same cavity, if any of the techniques indicated the presence of residual caries, the clinician-at their discretion-performed additional excavation to remove the affected tissue before proceeding to the final restoration. All teeth were subsequently restored using high-viscosity glass ionomer cement, in accordance with the ART protocol.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FACE + Caries Detection Dye | Active comparator | Diagnostic Test: FACE + Caries Detection Dye |
| FACE + Visual-Tactile Examination | Active comparator | Diagnostic Test: FACE + Visual-Tactile Examination |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 4-9 years at enrollment
- Healthy children who can cooperate with dental examination
- Multi-surface carious cavities that are asymptomatic (no acute symptoms)
- Written informed consent from parent/guardian and assent from the child
Key exclusion criteria (4 listed)
- Acute dental infection present
- Any systemic disease/condition
- Lack of cooperation during the procedure
- Refusal to participate / informed consent not obtained from parent/guardian and/or assent not obtained from the child
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 |
|---|---|---|
| FACE + Caries Detection DyeResidual caries detection performed using FACE and caries detection dye. | Diagnostic test | FACE + Caries Detection Dye |
| FACE + Visual-Tactile ExaminationResidual caries detection performed using FACE and visual-tactile method. | Diagnostic test | FACE + Visual-Tactile Examination |
Primary outcome
Assessment of residual caries detection accuracy using FACE and caries detector dye versus FACE and visual-tactile examination
Time frame: Baseline (immediately after caries removal procedure; single visit; up to 10 minutes; no follow-up required)
Residual caries detection will be performed in two diagnostic arms: (1) FACE combined with caries detector dye and (2) FACE combined with visual-tactile examination. After atraumatic caries removal, the presence or absence of residual caries will be evaluated on six cavity walls (axial, gingival, enamel-dentin junction, buccal, lingual, and pulpal). Diagnostic accuracy will be expressed as sensitivity, specificity, and overall accuracy compared with a reference standard (soft dentin confirmed by tactile evaluation).
4 secondary outcomes
Assessment of residual caries detection by visual-tactile examination
Time frame: Baseline (immediately after caries removal procedure; up to 5 minutes; no follow-up required)
Assessment of residual caries detection by caries detector dye
Time frame: Baseline (immediately after caries removal procedure; up to 10 minutes; no follow-up required)
Assessment of residual caries detection by FACE (Fluorescence-Aided Caries Excavation)
Time frame: Baseline (immediately after caries removal procedure; up to 10 minutes; no follow-up required)
Assessment of residual caries detection rate per cavity wall
Time frame: Baseline (immediately after caries removal procedure; up to 10 minutes; no follow-up required)
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 21 Jan 2026.
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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.
Burak Çarıkçıoğlu, Associate Professor principal investigator
Çanakkale Onsekiz Mart University
Hilal Öztürk, Research Assistant principal investigator
Çanakkale Onsekiz Mart University
İDİL AY ŞİMŞEK, Research Assistant principal investigator
Çanakkale Onsekiz Mart University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FACE + Caries Detection Dye and FACE + Visual-Tactile Examination in people with Primary Dental Caries, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
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 4 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 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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 Burak Çarıkçıoğlu, Associate Professor (00905054956091, carikcioglub@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of residual caries detection accuracy using FACE and caries detector dye versus FACE and visual-tactile examination (time frame: Baseline (immediately after caries removal procedure; single visit; up to 10 minutes; no follow-up required)). 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 21 Jan 2026.