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- Ensaio 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.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 2
Contactos e Locais
Contato de estudo
- Nome: Ghufran Dhari Awad, MSc. Orthodontics
- Número de telefone: +9647709644834
- E-mail: ghufrandhari822@gmail.com
Estude backup de contato
- Nome: Ali Mohammed Hameed, Ph.D. Orthodontics
- Número de telefone: +9647709644834
- E-mail: ghufrandharidata@gmail.com
Locais de estudo
-
-
Baghdad Governorate
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Baghdad, Baghdad Governorate, Iraque
- Recrutamento
- College of Dentistry, University of Baghdad
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Contato:
- College of Dentistry, University of Baghdad College of Dentistry, University of Baghdad
- Número de telefone: +964 770 581 4633
- E-mail: master@codental.uobaghdad.edu.iq
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Contato:
- Ghufran Dhari Mfarej, MSc. Orthodontics
- Número de telefone: +9647709644834
- E-mail: ghufrandhari822@gmail.com
-
Subinvestigador:
- Ghufran Mfarej
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Baghdad, Baghdad Governorate, Iraque, 10001
- Recrutamento
- College of Dentistry, University of Baghdad
-
Contato:
- College of Dentistry, University of Baghdad College of Dentistry, University of Baghdad
- Número de telefone: +964 770 581 4633
- E-mail: master@codental.uobaghdad.edu.iq
-
Contato:
- Ghufran Mfarej, MSc. Orthodontics
- Número de telefone: +9647709644834
- E-mail: ghufrandhari822@gmail.com
-
Subinvestigador:
- Ghufran Mfarej, MSc. Orthodontics
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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®)
|
Medicamento: Calcitriol (1,25-(OH)₂D₃) local injection • Agent: Calcitriol (1,25-(OH)₂D₃) Vitamin D3
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. |
|
Sem intervenção: 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
orthodontic tooth movement
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
biomarkers
Prazo: 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)
Prazo: 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
Prazo: 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
- Diretor de estudo: Ghufran Mfarej, college of dentistry /university of Baghdad
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Ácidos graxos
- Lipídios
- Fatores biológicos
- Compostos policíclicos
- Esteróides
- Compostos de anel fundido
- Prostaglandins
- Eicosanóides
- Ácidos graxos, insaturados
- AutoCoids
- Mediadores de inflamação
- CHOLESTENES
- Colestanos
- Esteróis
- Vitamina d
- Secosteróides
- Lipídios da membrana
- Hidroxicolecalciferols
- Di -hidroxicolecalciferols
- Colecalciferol
- Calcitriol
- Procedimentos cirúrgicos, operatórios
- Prostaglandins E
Outros números de identificação do estudo
- 1198426
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
LII, Biomarkers, root resorption, pain perception
Tipo de informação de suporte de compartilhamento de IPD
- SEIVA
- CIF
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