- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07842120
Comparing MOP, Prostaglandin E1, and Calcitriol to Accelerate Orthodontic Tooth Movement (acceleration)
A Comparative Clinical Evaluation of the Mini-Implant Facilitated Micro-Osteoperforation (MOP), Prostaglandin E1 and Calcitriol Injections in Accelerating of Orthodontic Tooth Movement: Randomized Controlled Clinical Trial
This study will compare the effects of MOP (micro-osteoperforation), prostaglandin E1, and calcitriol on the rate of orthodontic tooth movement. The study will evaluate whether these interventions can accelerate tooth movement during orthodontic treatment. The findings may help researchers better understand methods for making orthodontic treatment more efficient while evaluating the effects and safety of the interventions used in the study.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ghufran Dhari Awad, MSc. Orthodontics
- Número de teléfono: +9647709644834
- Correo electrónico: ghufrandhari822@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Ali Mohammed Hameed, Ph.D. Orthodontics
- Número de teléfono: +9647709644834
- Correo electrónico: ghufrandharidata@gmail.com
Ubicaciones de estudio
-
-
Baghdad Governorate
-
Baghdad, Baghdad Governorate, Irak
- Reclutamiento
- College of Dentistry, University of Baghdad
-
Contacto:
- College of Dentistry, University of Baghdad College of Dentistry, University of Baghdad
- Número de teléfono: +964 770 581 4633
- Correo electrónico: master@codental.uobaghdad.edu.iq
-
Contacto:
- Ghufran Dhari Mfarej, MSc. Orthodontics
- Número de teléfono: +9647709644834
- Correo electrónico: ghufrandhari822@gmail.com
-
Sub-Investigador:
- Ghufran Mfarej
-
Baghdad, Baghdad Governorate, Irak, 10001
- Reclutamiento
- College of Dentistry, University of Baghdad
-
Contacto:
- College of Dentistry, University of Baghdad College of Dentistry, University of Baghdad
- Número de teléfono: +964 770 581 4633
- Correo electrónico: master@codental.uobaghdad.edu.iq
-
Contacto:
- Ghufran Mfarej, MSc. Orthodontics
- Número de teléfono: +9647709644834
- Correo electrónico: ghufrandhari822@gmail.com
-
Sub-Investigador:
- Ghufran Mfarej, MSc. Orthodontics
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
-
Patient age 18-25.
- Patient with moderate crowding in mandibular anterior region with Little Irrigularity Index (LII) 4-6 mm.
- Indicated for fixed orthodontic appliance therapy (non-extraction treatment)
- Healthy periodontium (probing depths ≤3 mm, gingival and plaque indices6 scores ≤ 1, bleeding on probing ≤ 10%).
- Presence of all the mandibular permanent teeth, except the third molars.
- The overbite and overjet should not impede bracket placement on the mandibular anterior teeth.
Exclusion Criteria:
Systemic diseases affecting bone (osteoporosis, endocrine disorders), kidney disease, hyperparathyroidism.
- Medications affecting bone metabolism (bisphosphonates, systemic steroids, Vitamin D3 supplements).
- Known allergy to study agents or local anesthetics.
- History of previous orthodontic intervention
- History of trauma or root resorption in the mandibular anterior teeth
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Arm 1 - MOP (surgical)
Arm A - MOP (surgical) patients receiving orthodontic treatment using a straight wire appliance with MBT prescription brackets and a 0.022-inch slot • Anatomical target: labial cortical plate of mandibular anterior segment spanning canine to canine. Procedure: On the bonding day of the fixed appliance, self-drilling mini-implants (1.6 mm in diameter and 6 mm in length) were used to perform the MI-MOPs procedure in MOP (surgical) intervention group. Labial transmucosal MI-MOPs will be performed between the mandibular canine and lateral incisor bilaterally and between the central incisors. Two MI-MOPs at each site were performed, 2 mm and 4 mm below the alveolar bone crest. The perforation depth was decided by adding gingival tissue depth (measured by transgingival probing using Periodontal probe) plus buccal cortical bone depth (using coronal and sagittal sections of CBCT) at the level of planned perforation sites, procedure of MOP will be conducted at Day 1, , two months, 4 months. |
Micro-osteoperforation is a minimally invasive surgical technique designed to capture the therapeutic advantages of the Regional Acceleratory Phenomenon (RAP). First defined in bone healing, the RAP is a protective physiological mechanism where local tissue tolerance to structural injury triggers a transient, localized burst of tissue remodeling. By creating small, superficial pinhole perforations directly through the cortical plate of the alveolar bone into the spongy marrow spaces-without raising a full-thickness mucoperiosteal flap-MOP induces a highly localized state of controlled surgical trauma (Bolat, 2019; Farag et al., 2021). This injury provokes an immediate surge in pro-inflammatory cytokines (IL-1$\beta$, TNF-$\alpha$, and IL-6), leading to an elevated RANKL/OPG ratio. |
|
Experimental: Arm B - PGE₁ (pharmacological)
patients receiving orthodontic treatment using straight wire appliance with MBT prescription brackets and a 0.022-inch slot size (Pinnacle®, Ortho Technology, USA).
|
Prostaglandin analogs are synthetic compounds that mimic the effects of naturally occurring prostaglandins and are used for a wide range of clinical indications. They are used across multiple specialties, including ophthalmology, obstetrics, urology, gastroenterology, cardiology, and pulmonology. |
|
Experimental: Arm C - Calcitriol (1,25-(OH)₂D₃) local injection
patients receiving orthodontic treatment using straight wire appliance with MBT prescription brackets and a 0.022-inch slot size (Pinnacle®)
|
It is a biologically active form of vitamin D and plays an important role in calcium homeostasis (Reddy SR et al., 2015). A decrease in the serum calcium level stimulates secretion of PTH, which in turn increases excretion of PO4 3-, reabsorption of calcium from the kidneys, and hydroxylation of 25, hydroxycholecaliferol to 1, 25, DHCC. |
|
Sin intervención: Arm D -Control
patients receiving no intervention(surgical or pharmacological ) just only orthodontic treatment using a straight wire appliance with MBT prescription brackets and a 0.022-inch slot size (Pinnacle®, Ortho Technology, USA). participants receive the same standardized orthodontic mechanics, fixed orthodontic appliances (stainless steel MBT .022) were used in the current study with archwires sequence 0.014 NiTi 0.018 NiTi 0.017*0.025 NiTi 0.019*0.025 NiTi 0.019*0.025 SS (Ortho Technology, USA) (Al-Attar et al.,2022; Noori et al., 2025) Archwire will be replaced when expected improvement was achieved and next archwire could be inserted with minimal deflection. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
orthodontic tooth movement
Periodo de tiempo: 6 months
|
To compare the difference in the amount of tooth movement of the mandibular anterior segment in term of Little Irrigularity Index (LII) after 6 months from the start of treatment among four arms: MOP, local PGE₁ injection, local calcitriol injection, and control. |
6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
biomarkers
Periodo de tiempo: at baseline, 24 hours, 1 week and 4 weeks from the start of treatment
|
To compare the levels of Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL), Osteoprotegerin (OPG), Interleukin-1beta (IL-1β) biomarkers in gingival crevicular fluid (GCF) |
at baseline, 24 hours, 1 week and 4 weeks from the start of treatment
|
|
orthodontically-induced inflammatory root resorption (OIIRR)
Periodo de tiempo: before starting orthodontic treatment and after finishing leveling &alignment phase
|
To compare the amount of orthodontically-induced inflammatory root resorption (OIIRR) in the apical region of mandibular anterior teeth |
before starting orthodontic treatment and after finishing leveling &alignment phase
|
|
pain perception
Periodo de tiempo: during the 1st week & after each archwire placement
|
To compare the amount of pain perception during the 1st week after each archwire placement among the two pharmacological agents, microosteoperforation and control groups. |
during the 1st week & after each archwire placement
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Ghufran Mfarej, college of dentistry /university of Baghdad
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
- Ácidos grasos
- Lípidos
- Factores biológicos
- Compuestos policíclicos
- Esteroides
- Compuestos de anillo fusionado
- Prostaglandinas
- Eicosanoides
- Ácidos grasos, insaturados
- Autacoides
- Mediadores de inflamación
- Cholestenes
- Colestanos
- Esteroles
- Vitamina D
- Subesteroides
- Lípidos de membrana
- Hidroxicolecalciferols
- Dihidroxicolecalciferols
- Colecalciferol
- Calcitriol
- Procedimientos quirúrgicos, operativo
- Prostaglandins E
Otros números de identificación del estudio
- 1198426
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
LII, Biomarkers, root resorption, pain perception
Tipo de información de apoyo para compartir IPD
- SAVIA
- CIF
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.
producto fabricado y exportado desde los 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. .