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

2026年9月20日 更新者: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.

調査の概要

研究の種類

介入

入学 (推定)

60

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

    • Baghdad Governorate
      • Baghdad、Baghdad Governorate、イラク
        • 募集
        • College of Dentistry, University of Baghdad
        • コンタクト:
          • College of Dentistry, University of Baghdad College of Dentistry, University of Baghdad
          • 電話番号:+964 770 581 4633
          • メール:master@codental.uobaghdad.edu.iq
        • コンタクト:
        • 副調査官:
          • Ghufran Mfarej
      • Baghdad、Baghdad Governorate、イラク、10001
        • 募集
        • College of Dentistry, University of Baghdad
        • コンタクト:
          • College of Dentistry, University of Baghdad College of Dentistry, University of Baghdad
          • 電話番号:+964 770 581 4633
          • メール:master@codental.uobaghdad.edu.iq
        • コンタクト:
        • 副調査官:
          • Ghufran Mfarej, MSc. Orthodontics

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~25年 (大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:トリプル

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.

実験的: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.

実験的: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.

介入なし: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
orthodontic tooth movement
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
biomarkers
時間枠: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)
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • スタディディレクター:Ghufran Mfarej、college of dentistry /university of Baghdad

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年4月16日

一次修了 (推定)

2026年12月30日

研究の完了 (推定)

2027年2月1日

試験登録日

最初に提出

2026年9月20日

QC基準を満たした最初の提出物

2026年9月20日

最初の投稿 (実際)

2026年9月25日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月25日

QC基準を満たした最後の更新が送信されました

2026年9月20日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

LII, Biomarkers, root resorption, pain perception

IPD 共有サポート情報タイプ

  • SAP
  • ICF

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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