- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07740889
Effect of Nail Biting Habit on Mandibular Bone Structure: A Retrospective Radiological Study
Evaluation of the Effects of Nail Biting Habit on Mandibular Bone Structure Using Fractal Analysis and Panoramic Morphometric Indices: A Retrospective Radiological Study
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Nail biting (onychophagia) is classified as a body-focused repetitive behavior and represents a common parafunctional habit, particularly among children and adolescents. Continuous repetitive mechanical forces generated during nail biting may affect the stomatognathic system; however, the possible effects of this habit on mandibular bone structure have not been sufficiently investigated.
Fractal analysis is a radiological assessment method used to evaluate trabecular bone architecture by quantifying structural complexity. Higher fractal dimension values indicate increased complexity of bone patterns. In addition, panoramic morphometric indices such as mandibular cortical width, panoramic mandibular index, and Klemetti index provide information regarding cortical bone quality and quantity.
In this retrospective case-control study, existing panoramic radiographs of individuals with and without nail biting habits will be evaluated. Radiological parameters including fractal dimension, mandibular cortical width, panoramic mandibular index, and Klemetti index will be compared between groups. This study aims to determine whether nail biting habit is associated with measurable changes in mandibular trabecular and cortical bone characteristics.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: dilara nil günaçar
- Número de teléfono: +905412940104
- Correo electrónico: dilaranil.tomrukcu@erdogan.edu.tr
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Children aged 8-10 years who were examined at the Department of Pediatric Dentistry, Faculty of Dentistry, Recep Tayyip Erdoğan University.
- Systemically healthy participants.
- Participants with available diagnostic-quality panoramic radiographs obtained during routine dental examinations.
- Participants with and without a history of nail biting habit.
- Panoramic radiographs with sufficient image quality for fractal dimension analysis and mandibular morphometric measurements.
- Radiographs without periapical pathology in teeth adjacent to the regions of interest (ROI) used for fractal analysis.
- Participants with at least 20 existing teeth.
- Radiographic records with available parental radiographic information and consent documentation.
Exclusion Criteria:
- Participants with systemic diseases or conditions that may affect bone metabolism, including diabetes mellitus, osteoporosis, osteomalacia, renal diseases, hypothyroidism, or hyperparathyroidism.
- Participants using medications that may influence bone density or bone metabolism.
- Participants with temporomandibular joint disorders affecting the subcondylar region.
- Participants with mandibular pathological conditions, including cysts, tumors, or other lesions affecting mandibular bone structure.
- Participants with periapical pathology adjacent to the regions selected for fractal analysis.
- Participants with fewer than 20 teeth.
- Panoramic radiographs with insufficient diagnostic quality or image artifacts that prevent reliable measurements.
- Radiographs that do not allow accurate evaluation of mandibular cortical and trabecular bone parameters.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
Nail Biting Habit Group
This cohort includes systemically healthy children aged 8-10 years with a documented nail biting habit.
Existing panoramic radiographs obtained during routine dental examinations will be retrospectively analyzed.
Mandibular trabecular bone structure will be evaluated using fractal dimension analysis, and cortical bone characteristics will be assessed using mandibular cortical width, panoramic mandibular index, and Klemetti index measurements.
No intervention will be performed.
|
|
Control Group Without Nail Biting Habit
This cohort includes systemically healthy children aged 8-10 years without a history of nail biting habit.
Existing panoramic radiographs obtained during routine dental examinations will be retrospectively analyzed using the same radiological evaluation methods.
Mandibular trabecular and cortical bone characteristics will be compared with those of the nail biting habit group.
No intervention will be performed.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mandibular Trabecular Bone Structure Assessed by Fractal Dimension Analysis
Periodo de tiempo: Baseline
|
Mandibular trabecular bone architecture will be evaluated using fractal dimension analysis on panoramic radiographs.
Fractal dimension measurements will be performed using the box-counting method described by White and Rudolph.
Four regions of interest (ROIs) in the mandible will be analyzed, including the condylar subcortical region, supracortical region above the mandibular angle, area above the mandibular canal distal to the mental foramen, and anterior region of the mental foramen.
Measurements will be performed bilaterally, and the mean fractal dimension value will be calculated for each participant.
Higher fractal dimension values indicate greater trabecular bone complexity.
The fractal dimension values will be compared between individuals with and without nail biting habit.
|
Baseline
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Panoramic Mandibular Index (PMI)
Periodo de tiempo: Baseline
|
The panoramic mandibular index (PMI) will be calculated on panoramic radiographs as the ratio of mandibular cortical width to the distance between the inferior border of the mandible and the inferior margin of the mental foramen.
Measurements will be performed bilaterally, and the mean value will be used for analysis.
|
Baseline
|
Colaboradores e Investigadores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026/315
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .