Dental TraumaNCT07131462
Evaluation and Treatment of Crown Fractures Using the Modified Baysal Dental Trauma Index
A study testing Direct Composite Restoration, Cvek Pulpotomy and Endodontic Treatment in people with Dental Trauma and Crown Fractures, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
This study will be conducted by the Department of Pediatric Dentistry, Faculty of Dentistry, İnönü University, with the aim of evaluating the treatment processes and follow-up responses of patients aged between 6 and 14 years who will present with crown fractures in their maxillary or mandibular permanent incisors. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Dental Trauma, Crown Fractures, Tooth Fractures
- What is being tested?
- Direct Composite Restoration, Cvek Pulpotomy and Endodontic Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 1 Sep 2025
- 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 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 6 and 14 years
- Presence of traumatic dental injury involving a permanent tooth
- Type of injury classified as a complicated or uncomplicated crown fracture
- Informed consent obtained from the patient's parent or legal guardian
Who cannot join
- Patients younger than 6 or older than 14 years, or those presenting for non-trauma-related dental issues
- Patients with traumatic dental injuries other than crown fractures (e.g., luxation, avulsion)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Inonu University Faculty of Dentistry
Malatya, 44100
About this study
Official title: Evaluation of Crown Fractures in Permanent Teeth Following Dental Trauma Using the Modified Baysal Dental Trauma Index and Clinical Follow-Up of Their Treatments
This study will be conducted by the Department of Pediatric Dentistry, Faculty of Dentistry, İnönü University, with the aim of evaluating the treatment processes and follow-up responses of patients aged between 6 and 14 years who will present with crown fractures in their maxillary or mandibular permanent incisors.
Written informed consent will be obtained from the parents of all participating patients. The research will be carried out using a prospective observational design.
Read more
Initially, sociodemographic information as well as personal data such as the child's age and gender will be collected through a questionnaire designed for the parents. Additionally, trauma-related information-including the time, location, and cause of the injury-will be recorded in detail using a trauma assessment form developed for the study.
Each patient will undergo clinical and radiographic evaluations, and treatment planning and follow-up will be carried out based on these findings.
Read the detailed description
The sample size was determined based on a statistical power analysis. This analysis was conducted with an effect size of w = 0.5, an alpha error probability of α = 0.05, and a power of 1 - β = 0.8. Calculations performed for two degrees of freedom (df = 2) yielded a total required sample size of 39 participants.
Inclusion Criteria:
Age between 6 and 14 years Presence of a traumatic dental injury in a permanent tooth Type of TDI classified as either complicated or uncomplicated crown fracture Consent to participate provided by the patient's legal guardian
Exclusion Criteria:
Patients outside the 6-14 age range or presenting for other reasons Patients with traumatic dental injuries other than crown fractures
Types of Treatments Applied for Crown Fractures:
Restoration with composite resin Vital pulp therapies Regeneration Root canal treatment
Clinical Evaluation Criteria of Our Study:
Presence of pain and percussion sensitivity was considered a failure. Presence of abscess and fistula was considered a failure. Repair of the restoration was not considered a failure. Teeth showing loss of vitality and gray discoloration due to necrosis were considered a failure. The treatment success was evaluated using the Periapical Index (PAI) on periapical radiographs obtained from patients included in the study during follow-up visits. Internal and external root resorption were considered failures.
If the radiolucent area observed at the apex had developed or increased after treatment, it was considered a failure.
Reduction of initial radiolucencies observed in baseline radiographs of patients at the start of treatment or in those presenting late was considered a success.
Evaluation was performed according to the Periapical Index (PAI) described by Ørstavik et al. in 1986.
Disruption in the continuity of the lamina dura was considered a failure, whereas formation and continued development of the lamina dura were considered a success.
An increase in root length was considered a success. Calcification observed within the root canals was considered a failure. For immature traumatic teeth with an open apex at the start of treatment, continued and completed root maturation was considered a success.
- Conditions
- Dental Trauma, Crown Fractures, Tooth Fractures
- Being tested
- Direct Composite Restoration, Cvek Pulpotomy, Endodontic Treatment, Pulp Capping
- Keywords
- Complicated Crown Fractures, Uncomplicated Crown Fractures, Modified Baysal Dental Trauma Index, Permanent Teeth, Pediatric Dentistry
- Medical subject headings
- Tooth Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Composite RestorationProcedure or surgery
Application of direct composite resin to restore the fractured crown of permanent incisors.
Cvek PulpotomyProcedure or surgery
Partial pulpotomy (Cvek technique) will be performed for complicated crown fractures with vital pulp exposure. The goal is to maintain pulp vitality using biodentin.
Endodontic TreatmentProcedure or surgery
Root canal treatment will be applied to teeth with necrotic pulp or extensive pulp exposure not suitable for vital pulp therapy. Procedures will follow standard endodontic protocols.
Pulp CappingProcedure or surgery
In cases of minimal pulp exposure, a direct pulp capping procedure will be performed using biocompatible materials such as calcium hydroxide to preserve pulp vitality.
| Study group | Role | What they receive |
|---|---|---|
| Dental Trauma - Crown Fracture Group | Experimental | This arm includes children aged 6 to 14 years who present with crown fractures due to dental trauma. Treatment modality (direct composite restoration, Cvek pulpotomy, or endodontic therapy) will be selected based on clinical and radiographic findings. All patients will be followed over time to assess treatment outcomes. Receives: Procedure: Direct Composite Restoration; Procedure: Cvek Pulpotomy; Procedure: Endodontic Treatment; Procedure: Pulp Capping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Treated Teeth Without Clinical Symptoms or Radiographic Pathology at 12 Months (PAI Score ≤ 2)
Treatment success will be defined as the absence of spontaneous pain, swelling, sinus tract, abnormal mobility, discoloration, and the presence of radiographic healing or absence of periapical pathology, as assessed using the Periapical Index (PAI) by Ørstavik et al. (1986). Evaluations will be performed at 12 months post-treatment.
Measured: 12 months
Secondary outcomes (1)
Change in Periapical Index (PAI) Score From Baseline to 12 Months
Radiographic healing will be evaluated using the PAI scoring system, comparing baseline and 12-month follow-up periapical radiographs
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start1 Jan 2023
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental TraumaStudies of the same condition, open and under way.
- More trials run by Inonu 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuba Aydan, Inonu University
- Investigators
- Tuba Aydan, Pediatric Dentistry Specialist, Principal investigator, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131462
- Sponsor's protocol ID
- 2023/69
- Status last verified
- Aug 2025
- First submitted
- 29 Jul 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Crown Fractures in Permanent Teeth Following Dental Trauma Using the Modified Baysal Dental Trauma Index and Clinical Follow-Up of Their Treatments
- ClinicalTrials.gov ID
- NCT07131462
- Acronym / sponsor ID
- 2023/69
- Conditions
- Dental Trauma, Crown Fractures, Tooth Fractures
- Keywords
- Complicated Crown Fractures, Uncomplicated Crown Fractures, Modified Baysal Dental Trauma Index, Permanent Teeth, Pediatric Dentistry
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 20 Aug 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.
This study will be conducted by the Department of Pediatric Dentistry, Faculty of Dentistry, İnönü University, with the aim of evaluating the treatment processes and follow-up responses of patients aged between 6 and 14 years who will present with crown fractures in their maxillary or mandibular permanent incisors.
Written informed consent will be obtained from the parents of all participating patients. The research will be carried out using a prospective observational design.
Initially, sociodemographic information as well as personal data such as the child's age and gender will be collected through a questionnaire designed for the parents. Additionally, trauma-related information-including the time, location, and cause of the injury-will be recorded in detail using a trauma assessment form developed for the study.
Each patient will undergo clinical and radiographic evaluations, and treatment planning and follow-up will be carried out based on these findings.
Detailed description
The sample size was determined based on a statistical power analysis. This analysis was conducted with an effect size of w = 0.5, an alpha error probability of α = 0.05, and a power of 1 - β = 0.8. Calculations performed for two degrees of freedom (df = 2) yielded a total required sample size of 39 participants.
Inclusion Criteria:
Age between 6 and 14 years Presence of a traumatic dental injury in a permanent tooth Type of TDI classified as either complicated or uncomplicated crown fracture Consent to participate provided by the patient's legal guardian
Exclusion Criteria:
Patients outside the 6-14 age range or presenting for other reasons Patients with traumatic dental injuries other than crown fractures
Types of Treatments Applied for Crown Fractures:
Restoration with composite resin Vital pulp therapies Regeneration Root canal treatment
Clinical Evaluation Criteria of Our Study:
Presence of pain and percussion sensitivity was considered a failure. Presence of abscess and fistula was considered a failure. Repair of the restoration was not considered a failure. Teeth showing loss of vitality and gray discoloration due to necrosis were considered a failure. The treatment success was evaluated using the Periapical Index (PAI) on periapical radiographs obtained from patients included in the study during follow-up visits. Internal and external root resorption were considered failures.
If the radiolucent area observed at the apex had developed or increased after treatment, it was considered a failure.
Reduction of initial radiolucencies observed in baseline radiographs of patients at the start of treatment or in those presenting late was considered a success.
Evaluation was performed according to the Periapical Index (PAI) described by Ørstavik et al. in 1986.
Disruption in the continuity of the lamina dura was considered a failure, whereas formation and continued development of the lamina dura were considered a success.
An increase in root length was considered a success. Calcification observed within the root canals was considered a failure. For immature traumatic teeth with an open apex at the start of treatment, continued and completed root maturation was considered a success.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dental Trauma - Crown Fracture Group | Experimental | Procedure: Direct Composite Restoration, Procedure: Cvek Pulpotomy, Procedure: Endodontic Treatment, Procedure: Pulp CappingThis arm includes children aged 6 to 14 years who present with crown fractures due to dental trauma. Treatment modality (direct composite restoration, Cvek pulpotomy, or endodontic therapy) will be selected based on clinical and radiographic findings. All patients will be followed over time to assess treatment outcomes. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age between 6 and 14 years
- Presence of traumatic dental injury involving a permanent tooth
- Type of injury classified as a complicated or uncomplicated crown fracture
- Informed consent obtained from the patient's parent or legal guardian
Key exclusion criteria (2 listed)
- Patients younger than 6 or older than 14 years, or those presenting for non-trauma-related dental issues
- Patients with traumatic dental injuries other than crown fractures (e.g., luxation, avulsion)
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 |
|---|---|---|
| Direct Composite RestorationApplication of direct composite resin to restore the fractured crown of permanent incisors. | Procedure or surgery | Dental Trauma - Crown Fracture Group |
| Cvek PulpotomyPartial pulpotomy (Cvek technique) will be performed for complicated crown fractures with vital pulp exposure. The goal is to maintain pulp vitality using biodentin. | Procedure or surgery | Dental Trauma - Crown Fracture Group |
| Endodontic TreatmentRoot canal treatment will be applied to teeth with necrotic pulp or extensive pulp exposure not suitable for vital pulp therapy. Procedures will follow standard endodontic protocols. | Procedure or surgery | Dental Trauma - Crown Fracture Group |
| Pulp CappingIn cases of minimal pulp exposure, a direct pulp capping procedure will be performed using biocompatible materials such as calcium hydroxide to preserve pulp vitality. | Procedure or surgery | Dental Trauma - Crown Fracture Group |
Primary outcome
Proportion of Treated Teeth Without Clinical Symptoms or Radiographic Pathology at 12 Months (PAI Score ≤ 2)
Time frame: 12 months
Treatment success will be defined as the absence of spontaneous pain, swelling, sinus tract, abnormal mobility, discoloration, and the presence of radiographic healing or absence of periapical pathology, as assessed using the Periapical Index (PAI) by Ørstavik et al. (1986). Evaluations will be performed at 12 months post-treatment.
1 secondary outcome
Change in Periapical Index (PAI) Score From Baseline to 12 Months
Time frame: 12 months
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 20 Aug 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Tuba Aydan, Pediatric Dentistry Specialist principal investigator
Inonu 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 Direct Composite Restoration, Cvek Pulpotomy and Endodontic Treatment in people with Dental Trauma and Crown Fractures, run by Inonu 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 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: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2025. 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?
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?
Proportion of Treated Teeth Without Clinical Symptoms or Radiographic Pathology at 12 Months (PAI Score ≤ 2) (time frame: 12 months). 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 20 Aug 2025.