NCT07268443

Brief Summary

This retrospective study received ethical approval from the Ethics Committee of Dicle University Faculty of Medicine, Diyarbakır, Turkey (Decision No:03.05.2012-567). A priori power analysis (Cohen's d = 0.5, α = 0.05, 80% power) indicated that a minimum of 33 participants was required to achieve statistical reliability. Group 1 (Study Group) included 42 pediatric patients (17 females, 25 males; mean age: 12.54 ± 1.74 years) who experienced complicated crown-root fractures due to dental trauma between 2008 and 2023. All presented within one month of trauma, ensuring diagnostic uniformity. Group 2 (Control Group) included 25 orthodontic patients (9 females, 16 males; mean age: 12.60 ± 1.04 years) with Class I malocclusion and no TMJ (Temporomandibular Joint)-related symptoms. Controls were selected from orthodontic records based on skeletal harmony and availability of pre-treatment CBCT (Cone Beam Computerized Tomography) scans. In the study group, CBCT was utilized for diagnostic purposes to evaluate post-traumatic TMJ changes, as conventional imaging may not reveal subtle or asymptomatic alterations, particularly in growing children. CBCT scans in the control group were retrospectively analyzed from orthodontic records. These scans had been acquired prior to orthodontic treatment planning in accordance with standard clinical indications. In both groups, no additional radiation exposure was introduced for research purposes. Imaging followed the ALADA ( As Low As Diagnostically Acceptable) principle to balance diagnostic efficacy and radiation safety. Parental informed consent was obtained at the time of initial treatment. Data were extracted from standardized clinical and radiological records. All patients in Group 1 were evaluated and treated by a single clinician; likewise, control group patients were examined by a single orthodontist to maintain procedural consistency. All subjects underwent comprehensive clinical and CBCT-based assessments. TMJ pain was evaluated through palpation and mandibular movement (opening and closing). A four-point ordinal scale was used: No Pain, Mild, Moderate, Severe. Pain location was classified as: No Pain, Right TMJ, Left TMJ, or Bilateral. This classification supported both qualitative and quantitative assessment of TMJ symptom distribution. All CBCT scans were performed using an ICAT 3D system (Model 17-19, Imaging Sciences International, Hatfield, PA) with a 360° rotation, 120 kV, 5.0 mA, 9.6 s scan duration, and a voxel resolution of 0.3 mm. Images were analyzed using I-CAT software. The Ikeda and Kawamura (2009) method was used to measure anterior, superior, and posterior joint spaces between the condyle and glenoid fossa. The True Horizontal Line (THL) served as a reproducible reference plane. Measurements were performed with the mandible in a closed rest position. Non-parametric Mann-Whitney U tests were used for intergroup comparisons of joint space dimensions. Chi-square tests were used for categorical pain scores. A significance threshold of p ≤ 0.05 was set. Statistical analyses were performed using SPSS v21.0 (IBM Corp., Armonk, NY, USA).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2012

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

June 3, 2012

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2023

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 5, 2025

Completed
Last Updated

December 5, 2025

Status Verified

November 1, 2025

Enrollment Period

10.9 years

First QC Date

September 9, 2025

Last Update Submit

November 25, 2025

Conditions

Keywords

Temporomandibular disordersCBCT analysisPediatric TMJ DysfunctionDental Trauma

Outcome Measures

Primary Outcomes (1)

  • Changes in TMJ Joint Space Measurements

    Cone-beam computed tomography (CBCT) images were obtained with patients positioned in a standardized closed-mouth rest position. Linear joint space measurements were taken between the mandibular condyle and the glenoid fossa at three reference points: anterior, superior, and posterior. The analysis followed the standardized method of Ikeda \& Kawamura (2009), in which the True Horizontal Line (THL) is used as a reproducible reference plane. Measurements were recorded in millimeters directly on axial and sagittal CBCT slices using validated I-CAT software tools, ensuring high reproducibility and diagnostic accuracy. This approach minimizes positional variability and provides a reliable assessment of TMJ morphology in pediatric patients

    Baseline CBCT (pre-treatment, obtained within 1 month after trauma) and post-treatment CBCT (performed after completion of dental/orthodontic management, up to 1 month follow-up)

Secondary Outcomes (4)

  • Change in TMJ Pain Intensity

    Baseline (pre-treatment, within 1 month after trauma) and post-treatment (after clinical management, up to 1 month follow-up)

  • Change in TMJ Pain Location

    Baseline (pre-treatment, within 1 month after trauma) and post-treatment (after clinical management, up to 1 month follow-up)

  • Change in TMJ Pain on Palpation

    Baseline (pre-treatment, within 1 month after trauma) and post-treatment (after clinical management, up to 1 month follow-up)

  • Change in TMJ Pain During Mandibular Movements

    Baseline (pre-treatment, within 1 month after trauma) and post-treatment (after clinical management, up to 1 month follow-up)

Other Outcomes (1)

  • Reduction in Overall Functional Pain

    Baseline (pre-treatment, within 1 month after trauma) and post-treatment (after clinical management, up to 1 month follow-up)

Study Arms (2)

Trauma-associated TMD

Cohort: Pediatric patients aged 11-16 who presented within 1 month after complicated crown-root fractures and reported TMJ pain. CBCT and standardized clinical pain assessments were reviewed retrospectively. (n=42)

Orthodontic Controls

Cohort Description: "Orthodontic patients aged 12-16 (Class I malocclusion) without TMJ-related complaints; pre-treatment CBCTs reviewed retrospectively under the same imaging/assessment protocol. (n=25)"

Eligibility Criteria

Age11 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Single-center pediatric cohort drawn from dental trauma cases (presenting ≤1 month post-injury) and orthodontic records (Class I, asymptomatic) at a university clinic; retrospective review period 2008-2023. TMJ joint-space metrics via CBCT (Ikeda \& Kawamura method); pain scored on a 4-point ordinal scale; ALADA principles applied; no additional radiation for research.

You may qualify if:

  • Children/adolescents aged 11-16 years.
  • Cases: History of complicated crown-root fracture due to dental trauma; presentation within 1 month after trauma; documented TMJ pain (palpation and/or movement); CBCT available for TMJ assessment.
  • Controls: Orthodontic patients (Class I) aged 12-16 years with no TMJ-related complaints; pre-treatment CBCT available.
  • Availability of standardized clinical records (pain side/intensity; mandibular movement) sufficient for retrospective analysis.
  • Parental/guardian consent obtained at initial treatment per institutional policy.

You may not qualify if:

  • Systemic/rheumatologic or neuromuscular disorders affecting the TMJ (e.g., JIA).
  • Craniofacial syndromes, prior TMJ surgery, mandibular fractures involving the condyle, or forced/intubation trauma unrelated to dental injury.
  • Prior or ongoing occlusal splint/orthodontic therapy likely to alter TMJ loading before baseline imaging.
  • Inadequate/incomplete clinical records or poor-quality CBCT precluding reliable joint-space measurement.
  • Repeated or multiple traumas where timing cannot be ascertained relative to imaging.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dicle University Faculty of Dentistry, Diyarbakır, Turkey

Diyarbakır, Sur, +9021280, Turkey (Türkiye)

Location

Related Publications (3)

  • Ikeda K, Kawamura A. Assessment of optimal condylar position with limited cone-beam computed tomography. Am J Orthod Dentofacial Orthop. 2009 Apr;135(4):495-501. doi: 10.1016/j.ajodo.2007.05.021.

  • Spinas E, Giannetti L, Mameli A, Re D. Dental injuries in young athletes, a five-year follow-up study. Eur J Paediatr Dent. 2018 Sep;19(3):187-193. doi: 10.23804/ejpd.2018.19.03.4.

  • Al-Khotani A, Naimi-Akbar A, Albadawi E, Ernberg M, Hedenberg-Magnusson B, Christidis N. Prevalence of diagnosed temporomandibular disorders among Saudi Arabian children and adolescents. J Headache Pain. 2016;17:41. doi: 10.1186/s10194-016-0642-9. Epub 2016 Apr 22.

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Officials

  • Ismet R TOPTANCI, PhD/ Assist.Prof. Dr.

    Dicle Universty Dentistry Faculty Department of Pediatric Dentistry

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asisst. Prof.

Study Record Dates

First Submitted

September 9, 2025

First Posted

December 5, 2025

Study Start

June 3, 2012

Primary Completion

May 3, 2023

Study Completion

May 3, 2023

Last Updated

December 5, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

This is a retrospective observational study. Individual participant data will not be shared.

Locations