Cracked Tooth SyndromeCDCPNCT07837960
Exploration of Diagnosis, Etiology, and Prognosis Prediction of Cracked Teeth in Young Adults
An observational study of Cracked Tooth Syndrome, run by Fujian Medical University at 1 site in China.
Trial summary
Cracked teeth are a common dental problem where tiny cracks form in the teeth. These cracks can be hard to find early, and if not treated, they may cause the tooth to break. This study aims to see if a new, non-invasive imaging method called Near-Infrared Imaging (NIRI) can help us find these cracks better in young… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Cracked Tooth Syndrome
- What is being tested?
- Observational Assessment Only
- Type of treatment
- Pill or oral medicine
- How many people
- 161 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 1 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: This study enrolled volunteer students aged 18 to 30 years from Fujian Medical University, recruited via on-site presentations during class meetings between September 2025 and March 2026. A total of 161 participants were included in the final analysis. The study population included both males and females, with no restriction on gender. Healthy volunteers were accepted as long as they met the inclusion criteria.
Who may be able to join
- Adults aged 18 to 30 years old Presence of ≥20 natural teeth that are either unrestored or have minor restorations Willingness to provide written informed consent Capability to cooperate with clinical oral examination and NIRI scanning
Who cannot join
- Presence of <20 natural teeth History of radiotherapy or surgery in the maxillofacial region Inability to cooperate with clinical examinations or questionnaire surveys History of facial trauma Undergoing orthodontic treatment
Trial locations and contacts
1 site in 1 country.
China1 site
Fujian Medical University Stomatological Hospital
Fuzhou, Fujian, 350002
About this study
Cracked teeth are a common dental problem where tiny cracks form in the teeth. These cracks can be hard to find early, and if not treated, they may cause the tooth to break. This study aims to see if a new, non-invasive imaging method called Near-Infrared Imaging (NIRI) can help us find these cracks better in young adults aged 18 to 30 years. Participants will attend a single dental visit where they will receive a standard dental examination, including checks for pain when biting or when the tooth is tapped or exposed to cold. Additionally, pictures of their teeth will be taken using a special NIRI camera that uses a safe, painless light, and their teeth will be examined closely using a dental operating microscope, which is the current standard method for comparison. The main goals are to evaluate how accurate the NIRI method is compared to the microscope, to determine if NIRI can serve as a reliable alternative or helpful supplement for dentists, and to identify patterns and factors such as tooth position, wear, and bite that may be linked to cracked teeth, helping dentists recognize patients at higher risk. The study enrolled participants from September 2025 to March 2026 at the School and Hospital of Stomatology, Fujian Medical University.
Read the detailed description
The diagnosis of cracked teeth relies heavily on subjective clinical findings, including patient-reported pain upon biting, cold sensitivity, and visual inspection under magnification. However, these methods lack objective quantifiable measures, often leading to delayed or missed diagnoses. Near-Infrared Imaging (NIRI) has emerged as a promising non-invasive imaging modality that can detect subtle structural changes in tooth hard tissues. This study is designed to systematically evaluate the diagnostic utility of NIRI in detecting cracked teeth among young adults, using the dental operating microscope (OM) combined with clinical examination as the reference standard. This study was designed as a prospective, self-controlled, diagnostic accuracy trial. All participants underwent both diagnostic examinations: the index test was near-infrared imaging (NIRI) and the reference standard was operating microscope (OM) combined with conventional clinical examination.
- Conditions
- Cracked Tooth Syndrome
- Being tested
- Observational Assessment Only
- Keywords
- Cracked teeth, diagnostic accuracy, near-infrared imaging, young adults, dental operating microscope, tooth wear, occlusion
- Medical subject headings
- Cracked Tooth Syndrome, Tooth Wear, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational Assessment OnlyOther
This is an observational diagnostic study with no therapeutic intervention administered. Participants undergo a single baseline oral examination, including clinical assessment of occlusion, tooth wear, restoration status, and symptoms (biting pain, cold-stimulus pain, percussion pain), followed by two diagnostic imaging procedures: Near-Infrared Imaging (NIRI) and operating microscope (OM) examination. All procedures are non-invasive and performed for diagnostic data collection purposes only. No drug, device, or therapeutic procedure is administered as part of the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Young Adult Study Cohort | This group includes young adults aged 18 to 30 years who are enrolled in this diagnostic study. All participants will undergo a comprehensive baseline oral examination, including assessment of occlusion, tooth wear, restoration status, and clinical symptoms such as biting pain, cold-stimulus pain, and percussion pain. Each participant's teeth will be examined sequentially using Near-Infrared Imaging (NIRI) and a dental operating microscope (OM), with examiners blinded to each other's results. No intervention is administered; all assessments are observational and non-invasive. Receives: Other: Observational Assessment Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of NIRI for Detecting Cracked Teeth
Sensitivity and specificity of Near-Infrared Imaging (NIRI) for detecting cracked teeth, using dental operating microscope (OM) examination as the reference standard. Calculated at both the tooth level and the patient level with 95% confidence intervals.
Measured: At baseline upon completion of oral examinations
Positive and Negative Predictive Values of NIRI for Detecting Cracked Teeth
Positive predictive value (PPV) and negative predictive value (NPV) of Near-Infrared Imaging (NIRI) for detecting cracked teeth, using dental operating microscope (OM) examination as the reference standard. Calculated at both the tooth level and the patient level with 95% confidence intervals.
Measured: At baseline upon completion of oral examinations
Area Under the ROC Curve (AUC) of NIRI for Detecting Cracked Teeth
Overall discriminative ability of Near-Infrared Imaging (NIRI) assessed by the area under the receiver operating characteristic curve (AUC), with 95% confidence intervals at both the tooth and patient levels.
Measured: At baseline upon completion of oral examinations
Secondary outcomes (8)
Diagnostic Agreement Between NIRI and Operating Microscope（OM）
Cohen's Kappa statistic evaluating the inter-method agreement between Near-Infrared Imaging (NIRI) and operating microscope (OM) examination for cracked tooth diagnosis.
Measured: At baseline upon completion of oral examinations
Patient-Level Prevalence of Cracked Teeth
Proportion of participants classified as crack-positive by operating microscope (OM) examination, reported as a descriptive prevalence estimate in the study population.
Measured: At baseline upon completion of oral examinations
Crack Status and NIRI Diagnostic Performance by Tooth Position
Proportion of teeth classified as crack-positive by operating microscope (OM) examination, reported separately for anterior teeth, premolars, and molars as percentages of examined teeth in each tooth position category. Subgroup analyses of the primary outcomes (sensitivity, specificity, PPV, NPV, and AUC with 95% CIs) are reported separately for each tooth position, using OM as the reference standard.
Measured: At baseline upon completion of oral examinations
Crack Status and NIRI Diagnostic Performance by Tooth Wear
Proportion of teeth classified as crack-positive by OM examination, reported for teeth with versus without wear based on the Smith and Knight Tooth Wear Index (grades 0-4). Subgroup analyses of the primary outcomes (sensitivity, specificity, PPV, NPV, and AUC with 95% CIs) are reported by wear grade, using OM as the reference standard.
Measured: At baseline upon completion of oral examinations
Crack Status and NIRI Diagnostic Performance by Clinical Symptoms
Proportion of teeth classified as crack-positive by OM examination, reported separately for each clinical symptom (tenderness to percussion, pain on biting, and positive cold test). Subgroup analyses of the primary outcomes (sensitivity, specificity, PPV, NPV, and AUC with 95% CIs) are reported separately for teeth with versus without each symptom, using OM as the reference standard.
Measured: At baseline upon completion of oral examinations
Crack Status and NIRI Diagnostic Performance by Caries and Restoration Status
Proportion of teeth classified as crack-positive by OM examination, reported separately by caries status, filling status, and prosthetic restoration status. Subgroup analyses of the primary outcomes (sensitivity, specificity, PPV, NPV, and AUC with 95% CIs) are reported separately for each condition, using OM as the reference standard.
Measured: At baseline upon completion of oral examinations
Crack Status and NIRI Diagnostic Performance by Special Dental Conditions
Proportion of teeth classified as crack-positive by OM examination, reported separately for each special dental condition (enamel hypoplasia, lateral displacement, joint clicking, central cusp deformity, and fused tooth). Subgroup analyses of the primary outcomes (sensitivity, specificity, PPV, NPV, and AUC with 95% CIs) are reported separately for each condition, using OM as the reference standard.
Measured: At baseline upon completion of oral examinations
Patient-Level Crack Status and NIRI Diagnostic Performance by Occlusal Factors
Proportion of participants classified as crack-positive by OM examination, reported separately by occlusal factors (sex, overbite, overjet, and molar relationship). Subgroup analyses of the primary outcomes (sensitivity, specificity, PPV, NPV, and AUC with 95% CIs) are reported at the patient level, stratified by each occlusal factor, using OM as the reference standard.
Measured: At baseline upon completion of oral examinations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start1 Sep 2025
- Primary completion1 Mar 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cracked Tooth SyndromeStudies of the same condition, open and under way.
- More trials run by Fujian Medical UniversityThe sponsor's other registered studies.
- 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
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao Yu, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07837960
- Sponsor's protocol ID
- 2025ECSS134
- Other IDs
- MR-35-26-072113
- Acronym
- CDCP
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data, including demographic information, clinical examination results (tooth position, occlusion, tooth wear, restoration status, and clinical symptoms), and imaging data from Near-Infrared Imaging (NIRI) and operating microscope examinations will be shared.
Publications
Hilton TJ, Funkhouser E, Ferracane JL, Gilbert GH, Baltuck C, Benjamin P, Louis D, Mungia R, Meyerowitz C; National Dental Practice-Based Research Network Collaborative Group. Correlation between symptoms and external characteristics of cracked teeth: Findings from The National Dental Practice-Based Research Network. J Am Dent Assoc. 2017 Apr;148(4):246-256.e1. doi: 10.1016/j.adaj.2016.12.023. Epub 2017 Feb 2.
PubMed 28160942
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Diagnosis, Etiology, and Prognosis Prediction of Cracked Teeth in Young Adults
- ClinicalTrials.gov ID
- NCT07837960
- Acronym / sponsor ID
- CDCP / 2025ECSS134
- Conditions
- Cracked Tooth Syndrome
- Keywords
- Cracked teeth, diagnostic accuracy, near-infrared imaging, young adults, dental operating microscope, tooth wear, occlusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 24 Sep 2026 (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.
Cracked teeth are a common dental problem where tiny cracks form in the teeth. These cracks can be hard to find early, and if not treated, they may cause the tooth to break. This study aims to see if a new, non-invasive imaging method called Near-Infrared Imaging (NIRI) can help us find these cracks better in young adults aged 18 to 30 years. Participants will attend a single dental visit where they will receive a standard dental examination, including checks for pain when biting or when the tooth is tapped or exposed to cold. Additionally, pictures of their teeth will be taken using a special NIRI camera that uses a safe, painless light, and their teeth will be examined closely using a dental operating microscope, which is the current standard method for comparison. The main goals are to evaluate how accurate the NIRI method is compared to the microscope, to determine if NIRI can serve as a reliable alternative or helpful supplement for dentists, and to identify patterns and factors such as tooth position, wear, and bite that may be linked to cracked teeth, helping dentists recognize patients at higher risk. The study enrolled participants from September 2025 to March 2026 at the School and Hospital of Stomatology, Fujian Medical University.
Detailed description
The diagnosis of cracked teeth relies heavily on subjective clinical findings, including patient-reported pain upon biting, cold sensitivity, and visual inspection under magnification. However, these methods lack objective quantifiable measures, often leading to delayed or missed diagnoses. Near-Infrared Imaging (NIRI) has emerged as a promising non-invasive imaging modality that can detect subtle structural changes in tooth hard tissues. This study is designed to systematically evaluate the diagnostic utility of NIRI in detecting cracked teeth among young adults, using the dental operating microscope (OM) combined with clinical examination as the reference standard. This study was designed as a prospective, self-controlled, diagnostic accuracy trial. All participants underwent both diagnostic examinations: the index test was near-infrared imaging (NIRI) and the reference standard was operating microscope (OM) combined with conventional clinical examination.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Young Adult Study Cohort | – | Other: Observational Assessment OnlyThis group includes young adults aged 18 to 30 years who are enrolled in this diagnostic study. All participants will undergo a comprehensive baseline oral examination, including assessment of occlusion, tooth wear, restoration status, and clinical symptoms such as biting pain, cold-stimulus pain, and percussion pain. Each participant's teeth will be examined sequentially using Near-Infrared Imaging (NIRI) and a dental operating microscope (OM), with examiners blinded to each other's results. No intervention is administered; all assessments are observational and non-invasive. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This study enrolled volunteer students aged 18 to 30 years from Fujian Medical University, recruited via on-site presentations during class meetings between September 2025 and March 2026. A total of 161 participants were included in the final analysis. The study population included both males and females, with no restriction on gender. Healthy volunteers were accepted as long as they met the inclusion criteria.
Key inclusion criteria (1 listed)
- Adults aged 18 to 30 years old Presence of ≥20 natural teeth that are either unrestored or have minor restorations Willingness to provide written informed consent Capability to cooperate with clinical oral examination and NIRI scanning
Key exclusion criteria (1 listed)
- Presence of <20 natural teeth History of radiotherapy or surgery in the maxillofacial region Inability to cooperate with clinical examinations or questionnaire surveys History of facial trauma Undergoing orthodontic treatment
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 |
|---|---|---|
| Observational Assessment OnlyThis is an observational diagnostic study with no therapeutic intervention administered. Participants undergo a single baseline oral examination, including clinical assessment of occlusion, tooth wear, restoration status, and symptoms (biting pain, cold-stimulus pain, percussion pain), followed by two diagnostic imaging procedures: Near-Infrared Imaging (NIRI) and operating microscope (OM) examination. All procedures are non-invasive and performed for diagnostic data collection purposes only. No drug, device, or therapeutic procedure is administered as part of the study protocol. | Other | Young Adult Study Cohort |
Primary outcome
Sensitivity and Specificity of NIRI for Detecting Cracked Teeth
Time frame: At baseline upon completion of oral examinations
Sensitivity and specificity of Near-Infrared Imaging (NIRI) for detecting cracked teeth, using dental operating microscope (OM) examination as the reference standard. Calculated at both the tooth level and the patient level with 95% confidence intervals.
Positive and Negative Predictive Values of NIRI for Detecting Cracked Teeth
Time frame: At baseline upon completion of oral examinations
Positive predictive value (PPV) and negative predictive value (NPV) of Near-Infrared Imaging (NIRI) for detecting cracked teeth, using dental operating microscope (OM) examination as the reference standard. Calculated at both the tooth level and the patient level with 95% confidence intervals.
Area Under the ROC Curve (AUC) of NIRI for Detecting Cracked Teeth
Time frame: At baseline upon completion of oral examinations
Overall discriminative ability of Near-Infrared Imaging (NIRI) assessed by the area under the receiver operating characteristic curve (AUC), with 95% confidence intervals at both the tooth and patient levels.
8 secondary outcomes
Diagnostic Agreement Between NIRI and Operating Microscope（OM）
Time frame: At baseline upon completion of oral examinations
Patient-Level Prevalence of Cracked Teeth
Time frame: At baseline upon completion of oral examinations
Crack Status and NIRI Diagnostic Performance by Tooth Position
Time frame: At baseline upon completion of oral examinations
Crack Status and NIRI Diagnostic Performance by Tooth Wear
Time frame: At baseline upon completion of oral examinations
Crack Status and NIRI Diagnostic Performance by Clinical Symptoms
Time frame: At baseline upon completion of oral examinations
Crack Status and NIRI Diagnostic Performance by Caries and Restoration Status
Time frame: At baseline upon completion of oral examinations
Crack Status and NIRI Diagnostic Performance by Special Dental Conditions
Time frame: At baseline upon completion of oral examinations
Patient-Level Crack Status and NIRI Diagnostic Performance by Occlusal Factors
Time frame: At baseline upon completion of oral examinations
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Background: PubMed 28160942Hilton TJ, Funkhouser E, Ferracane JL, Gilbert GH, Baltuck C, Benjamin P, Louis D, Mungia R, Meyerowitz C; National Dental Practice-Based Research Network Collaborative Group. Correlation between symptoms and external characteristics of cracked teeth: Findings from The National Dental Practice-Based Research Network. J Am Dent Assoc. 2017 Apr;148(4):246-256.e1. doi: 10.1016/j.adaj.2016.12.023. Epub 2017 Feb 2.
- Individual participant dataSharing planned: Yes. De-identified individual participant data, including demographic information, clinical examination results (tooth position, occlusion, tooth wear, restoration status, and clinical symptoms), and imaging data from Near-Infrared Imaging (NIRI) and operating microscope examinations will be shared.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cracked Tooth Syndrome, run by Fujian Medical University at 1 site in China.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 24 Sep 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity of NIRI for Detecting Cracked Teeth (time frame: At baseline upon completion of oral examinations). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07837960, which also lists 1 linked publication.
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 24 Sep 2026.