NCT07134348

Brief Summary

Retrospective data analysis of children with primary dental trauma and follow-up visual examination to find out the sequelae.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 21, 2025

Completed
Last Updated

August 21, 2025

Status Verified

August 1, 2025

Enrollment Period

6.4 years

First QC Date

August 14, 2025

Last Update Submit

August 14, 2025

Conditions

Keywords

deciduous teeth, dental trauma, enamel hypoplasia, sequelae, successors

Outcome Measures

Primary Outcomes (1)

  • enamel hypoplasia

    developmental enamel defect with color change

    2018 and 2022

Study Arms (2)

Trauma Group

Children with primary teeth trauma history

Control Group

no history random observation in clinic.

Eligibility Criteria

Age0 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University

Kayseri, 38039, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Enamel Hypoplasia

Condition Hierarchy (Ancestors)

Developmental Defects of EnamelTooth AbnormalitiesStomatognathic System AbnormalitiesStomatognathic DiseasesTooth DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

August 14, 2025

First Posted

August 21, 2025

Study Start

January 1, 2018

Primary Completion

May 31, 2024

Study Completion

May 31, 2024

Last Updated

August 21, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations