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

ConditionAccelerated Orthodontic Tooth Movement
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-25
SponsorGhufran Dhari Awad

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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%).

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • PGE₁ (pharmacological) • Agent: Prostaglandin E1

    Drug

    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.

  • Calcitriol (1,25-(OH)₂D₃) local injection • Agent: Calcitriol (1,25-(OH)₂D₃) Vitamin D3

    Drug

    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.

  • microosteoperforation MOP (surgical)

    Procedure/Surgery

    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.

Treatment groups

60 Participants
are divided into 4 treatment groups
Group A: Arm 1 - MOP (surgical)Experimental treatment 1 intervention
Group B: Arm B - PGE₁ (pharmacological)Experimental treatment 1 intervention
Group C: Arm C - Calcitriol (1,25-(OH)₂D₃) local injectionExperimental treatment 1 intervention
Group D: Arm D -ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

orthodontic tooth movement

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.

Time frame
6 months

Secondary outcomes

1

biomarkers

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)

Time frame
at baseline, 24 hours, 1 week and 4 weeks from the start of treatment
2

orthodontically-induced inflammatory root resorption (OIIRR)

To compare the amount of orthodontically-induced inflammatory root resorption (OIIRR) in the apical region of mandibular anterior teeth

Time frame
before starting orthodontic treatment and after finishing leveling &alignment phase
3

pain perception

To compare the amount of pain perception during the 1st week after each archwire placement among the two pharmacological agents, microosteoperforation and control groups.

Time frame
during the 1st week & after each archwire placement

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ghufran Dhari Awad

Lead sponsor

University of Baghdad

Sponsor institution

Source ClinicalTrials.gov
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