NCT05832359

Brief Summary

The aim of our study is to examine possible disease-related changes in dental age and mandibular bone morphology in childhood rheumatic diseases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
278

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 27, 2023

Completed
22 days until next milestone

Study Start

First participant enrolled

May 19, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2023

Completed
Last Updated

December 6, 2023

Status Verified

December 1, 2023

Enrollment Period

7 months

First QC Date

December 14, 2022

Last Update Submit

December 5, 2023

Conditions

Keywords

Childhood rheumatic diseases

Outcome Measures

Primary Outcomes (1)

  • Dental Age Estimation

    The study group will be comprised of newly diagnosed pediatric patients who applied to Umraniye Training and Research Hospital Division of Pediatric Rheumatology and whose treatment is ongoing, and the control group will be composed of pediatric patients without systemic disease who applied to Marmara University Faculty of Dentistry Department of Pedodontics. In the study, digital panoramic x-rays of the patients will be evaluated and dental age estimation with Willems method will be made.

    3 months

Secondary Outcomes (1)

  • Mandibular bone morphometric measurements

    3 months

Study Arms (2)

Children diagnosed with childhood rheumatic disease

EXPERIMENTAL
Radiation: Panoramic rad.

Healthy children

EXPERIMENTAL
Radiation: Panoramic rad.

Interventions

In the study, digital panoramic x-rays of the patients will be evaluated and dental age estimation with Willems method and mandibular bone morphometric measurements will be made.

Children diagnosed with childhood rheumatic diseaseHealthy children

Eligibility Criteria

Age6 Years - 14 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsFemale/Male
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Patients aged 6 to 14 years with childhood rheumatism
  • Patients without bilateral congenital germ deficiency in the lower teeth
  • Patients with seven teeth (except no #8) on the left of the mandibula (No seven teeth on the left of the mandibula, there should be a symmetrical tooth on the right of the mandibula.

You may not qualify if:

  • Patients with bilateral congenital germ deficiency in lower teeth in intraoral and/or radiographic examinations
  • Patients with asymmetry and magnification errors and where anatomical structures cannot be seen clearly in the panoramic x-ray
  • Patients with a significant number of missing teeth due to trauma or disease, root canal treatment, and pathological tooth structure
  • Patients with a history of other chronic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ecem Ipek

Istanbul, 34736, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2022

First Posted

April 27, 2023

Study Start

May 19, 2023

Primary Completion

December 1, 2023

Study Completion

December 5, 2023

Last Updated

December 6, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations