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.
調査の概要
状態
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前:Ghufran Dhari Awad, MSc. Orthodontics
- 電話番号:+9647709644834
- メール:ghufrandhari822@gmail.com
研究連絡先のバックアップ
- 名前:Ali Mohammed Hameed, Ph.D. Orthodontics
- 電話番号:+9647709644834
- メール:ghufrandharidata@gmail.com
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:
- Ghufran Dhari Mfarej, MSc. Orthodontics
- 電話番号:+9647709644834
- メール:ghufrandhari822@gmail.com
-
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:
- Ghufran Mfarej, MSc. Orthodontics
- 電話番号:+9647709644834
- メール:ghufrandhari822@gmail.com
-
副調査官:
- Ghufran Mfarej, MSc. Orthodontics
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
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
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).
|
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®)
|
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
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
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 1198426
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?
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
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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