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Comparing MOP, Prostaglandin E1, and Calcitriol to Accelerate Orthodontic Tooth Movement (acceleration)

20. september 2026 oppdatert av: Ghufran Dhari Awad

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.

Studieoversikt

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

    • Baghdad Governorate
      • Baghdad, Baghdad Governorate, Irak
        • Rekruttering
        • College of Dentistry, University of Baghdad
        • Ta kontakt med:
          • College of Dentistry, University of Baghdad College of Dentistry, University of Baghdad
          • Telefonnummer: +964 770 581 4633
          • E-post: master@codental.uobaghdad.edu.iq
        • Ta kontakt med:
        • Underetterforsker:
          • Ghufran Mfarej
      • Baghdad, Baghdad Governorate, Irak, 10001
        • Rekruttering
        • College of Dentistry, University of Baghdad
        • Ta kontakt med:
          • College of Dentistry, University of Baghdad College of Dentistry, University of Baghdad
          • Telefonnummer: +964 770 581 4633
          • E-post: master@codental.uobaghdad.edu.iq
        • Ta kontakt med:
        • Underetterforsker:
          • Ghufran Mfarej, MSc. Orthodontics

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 25 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.

Eksperimentell: 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).

  • Dose & sites (mandibular anterior): 60 µg per visit, 10 µg (0.02mL) per site injected in to PDL at 6 sites across the mandibular anterior segment (one injection for each single tooth).
  • Timing: single dose at Day 1; repeat every two weeks for 4 months. PGE1 injection will be preceded by Mental nerve block bilaterally using local anesthetic solution . The calculation of Prostaglandin E₁ dose that will be used in the current study occur according to previous clinical trials. However, in our study the target site are six mandibular anterior teeth, by multiplying dose per tooth by number of teeth, so the recommended dose will be 60 µg per visit distributed as 10 µg (0.02mL) per site. Furthermore, the normal physiological serum level for Prostaglandin E₁ 1.2-1.8 µg/mL taken in consideration

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.

Eksperimentell: 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®)

  • Dose & sites: 60 pg per visit, 10 pg per site injected in to PDL at 6 sites across the mandibular anterior segment (one injection for each single tooth)
  • Timing: single dose on Day 1; repeats every two weeks for 4 months. Calcitriol injection is preceded by Mental nerve block bilaterally using local anesthetic solution to relieve pain usually accompanied with injection techniques. In the current study, Dimethylsulfoxide (0.2 mL) (DMSO, Bisolve B.V., Netherlands) will be used for dilution with dilution factor (1:20000000) and worked as a vehicle which used in previous clinical trials The calculation of Calcitriol dose that will be used in the current study occur according to previous clinical trials and normal physiological serum level for Calcitriol is 25-66 pg/mL . So, recommended dose will be 60 pg per visit distributed as 10 pg per site

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.

Ingen inngripen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
orthodontic tooth movement
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
biomarkers
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Studieleder: Ghufran Mfarej, college of dentistry /university of Baghdad

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

16. april 2026

Primær fullføring (Antatt)

30. desember 2026

Studiet fullført (Antatt)

1. februar 2027

Datoer for studieregistrering

Først innsendt

20. september 2026

Først innsendt som oppfylte QC-kriteriene

20. september 2026

Først lagt ut (Faktiske)

25. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. september 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

LII, Biomarkers, root resorption, pain perception

IPD-deling Støtteinformasjonstype

  • SEVJE
  • ICF

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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