- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 2
Contatti e Sedi
Contatto studio
- Nome: Ghufran Dhari Awad, MSc. Orthodontics
- Numero di telefono: +9647709644834
- Email: ghufrandhari822@gmail.com
Backup dei contatti dello studio
- Nome: Ali Mohammed Hameed, Ph.D. Orthodontics
- Numero di telefono: +9647709644834
- Email: ghufrandharidata@gmail.com
Luoghi di studio
-
-
Baghdad Governorate
-
Baghdad, Baghdad Governorate, Iraq
- Reclutamento
- College of Dentistry, University of Baghdad
-
Contatto:
- College of Dentistry, University of Baghdad College of Dentistry, University of Baghdad
- Numero di telefono: +964 770 581 4633
- Email: master@codental.uobaghdad.edu.iq
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Contatto:
- Ghufran Dhari Mfarej, MSc. Orthodontics
- Numero di telefono: +9647709644834
- Email: ghufrandhari822@gmail.com
-
Sub-investigatore:
- Ghufran Mfarej
-
Baghdad, Baghdad Governorate, Iraq, 10001
- Reclutamento
- College of Dentistry, University of Baghdad
-
Contatto:
- College of Dentistry, University of Baghdad College of Dentistry, University of Baghdad
- Numero di telefono: +964 770 581 4633
- Email: master@codental.uobaghdad.edu.iq
-
Contatto:
- Ghufran Mfarej, MSc. Orthodontics
- Numero di telefono: +9647709644834
- Email: ghufrandhari822@gmail.com
-
Sub-investigatore:
- Ghufran Mfarej, MSc. Orthodontics
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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. |
|
Sperimentale: 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. |
|
Sperimentale: 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. |
|
Nessun intervento: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
orthodontic tooth movement
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
biomarkers
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Ghufran Mfarej, college of dentistry /university of Baghdad
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Acidi grassi
- Lipidi
- Fattori biologici
- Composti policiclici
- Steroidi
- Composti anelli fusi
- Prostaglandine
- Eicosanoidi
- Acidi grassi, insaturi
- Autacoidi
- Mediatori di infiammazione
- Colesteni
- Colestani
- Steroli
- Vitamina D.
- Secosteroidi
- Lipidi a membrana
- Idrossicolecalciferols
- Diidrossilolecalciferoli
- Colecalciferolo
- Calcitriolo
- Procedure chirurgiche, operative
- Prostaglandins E
Altri numeri di identificazione dello studio
- 1198426
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
LII, Biomarkers, root resorption, pain perception
Tipo di informazioni di supporto alla condivisione IPD
- LINFA
- ICF
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
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