이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2026년 9월 20일 업데이트: 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.

연구 개요

연구 유형

중재적

등록 (추정된)

60

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

    • Baghdad Governorate
      • Baghdad, Baghdad Governorate, 이라크
        • 모병
        • College of Dentistry, University of Baghdad
        • 연락하다:
          • College of Dentistry, University of Baghdad College of Dentistry, University of Baghdad
          • 전화번호: +964 770 581 4633
          • 이메일: master@codental.uobaghdad.edu.iq
        • 연락하다:
        • 부수사관:
          • Ghufran Mfarej
      • Baghdad, Baghdad Governorate, 이라크, 10001
        • 모병
        • College of Dentistry, University of Baghdad
        • 연락하다:
          • College of Dentistry, University of Baghdad College of Dentistry, University of Baghdad
          • 전화번호: +964 770 581 4633
          • 이메일: master@codental.uobaghdad.edu.iq
        • 연락하다:
        • 부수사관:
          • Ghufran Mfarej, MSc. Orthodontics

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.

실험적: 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.

실험적: 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.

간섭 없음: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
orthodontic tooth movement
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
biomarkers
기간: 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)
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 연구 책임자: Ghufran Mfarej, college of dentistry /university of Baghdad

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 4월 16일

기본 완료 (추정된)

2026년 12월 30일

연구 완료 (추정된)

2027년 2월 1일

연구 등록 날짜

최초 제출

2026년 9월 20일

QC 기준을 충족하는 최초 제출

2026년 9월 20일

처음 게시됨 (실제)

2026년 9월 25일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 25일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 20일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

LII, Biomarkers, root resorption, pain perception

IPD 공유 지원 정보 유형

  • 수액
  • ICF

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다