Dental TraumaNCT07134348
Evaluation of Sequelae in Permanent Successors Following Traumatic Injuries to Primary Teeth
An observational study of Dental Trauma and Enamel Hypoplasia, run by Zeynep Aslı GÜÇLÜ at 1 site in Turkey (Türkiye).
Trial summary
Retrospective data analysis of children with primary dental trauma and follow-up visual examination to find out the sequelae. Read more about this study
- Who is it for?
- Ages 0 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Trauma, Enamel Hypoplasia, Sequelae
- How many people
- 173 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 31 May 2024
- 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 0 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: * Data from 275 traumatized primary teeth of 137 children * 101 children were included in the study 36 children excluded because the corresponding permanent successors had not yet erupted, and four permanent teeth and secondary trauma
Who may be able to join
- • Children who had experienced TDI-p
- Presence of a permanent tooth germ below the primary teeth
- Children aged between 5 and 12 years, regardless of sex
- Patients and their guardians who agreed to participate in follow-up sessions
- Permanent teeth that had fully erupted according to Von Arx's [16] classification.
Who cannot join
- • Children with long-term antibiotic use due to chronic illnesses that could cause enamel hypoplasia
- Children with congenital absence of permanent tooth germs
- Permanent teeth with caries or restorations due to trauma or other causes
- Permanent teeth that had not yet erupted or had only partially erupted
- Children with primary tooth trauma who were unable to attend the follow-up session
- Children with a history of trauma to their permanent teeth
- Children without any history of trauma to primary teeth
Trial locations and contacts
1 site in 1 country.
About this study
Retrospective data analysis of children with primary dental trauma and follow-up visual examination to find out the sequelae.
Read the detailed description
An observational study of permanent teeth that have enamel defects, coloration, or developmental disruption after primary tooth injury. A control group without history of trauma or dental injury to compare the enamel defect statistics.
- Conditions
- Dental Trauma, Enamel Hypoplasia, Sequelae, Sequelae Successors
- Keywords
- deciduous teeth, dental trauma, enamel hypoplasia, sequelae, successors
- Medical subject headings
- Dental Enamel Hypoplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Trauma Group | Children with primary teeth trauma history | |
| Control Group | no history random observation in clinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
enamel hypoplasia
developmental enamel defect with color change
Measured: 2018 and 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start1 Jan 2018
- Primary completion31 May 2024
- Study completion31 May 2024
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.
- 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
- Other
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeynep Aslı GÜÇLÜ
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zeynep Aslı GÜÇLÜ, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07134348
- Sponsor's protocol ID
- 2024/267
- Status last verified
- Aug 2025
- First submitted
- 14 Aug 2025
- Last updated
- 21 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 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sequelae in Permanent Successors Following Traumatic Injuries to Primary Teeth
- ClinicalTrials.gov ID
- NCT07134348
- Acronym / sponsor ID
- 2024/267
- Conditions
- Dental Trauma, Enamel Hypoplasia, Sequelae, Sequelae Successors
- Keywords
- deciduous teeth, dental trauma, enamel hypoplasia, sequelae, successors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Zeynep Aslı GÜÇLÜUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 21 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.
Retrospective data analysis of children with primary dental trauma and follow-up visual examination to find out the sequelae.
Detailed description
An observational study of permanent teeth that have enamel defects, coloration, or developmental disruption after primary tooth injury. A control group without history of trauma or dental injury to compare the enamel defect statistics.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trauma Group | – | –Children with primary teeth trauma history |
| Control Group | – | –no history random observation in clinic. |
Who may qualify
- Ages
- 0 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- * Data from 275 traumatized primary teeth of 137 children * 101 children were included in the study 36 children excluded because the corresponding permanent successors had not yet erupted, and four permanent teeth and secondary trauma
Key inclusion criteria (5 listed)
- • Children who had experienced TDI-p
Key exclusion criteria (7 listed)
- • Children with long-term antibiotic use due to chronic illnesses that could cause enamel hypoplasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
enamel hypoplasia
Time frame: 2018 and 2022
developmental enamel defect with color change
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 21 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.
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 Dental Trauma and Enamel Hypoplasia, run by Zeynep Aslı GÜÇLÜ 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 5 inclusion and 7 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 21 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?
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?
enamel hypoplasia (time frame: 2018 and 2022). 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 Aug 2025.