- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07842120
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.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Ghufran Dhari Awad, MSc. Orthodontics
- 전화번호: +9647709644834
- 이메일: ghufrandhari822@gmail.com
연구 연락처 백업
- 이름: Ali Mohammed Hameed, Ph.D. Orthodontics
- 전화번호: +9647709644834
- 이메일: ghufrandharidata@gmail.com
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:
- Ghufran Dhari Mfarej, MSc. Orthodontics
- 전화번호: +9647709644834
- 이메일: ghufrandhari822@gmail.com
-
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:
- Ghufran Mfarej, MSc. Orthodontics
- 전화번호: +9647709644834
- 이메일: ghufrandhari822@gmail.com
-
부수사관:
- Ghufran Mfarej, MSc. Orthodontics
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
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
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).
|
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®)
|
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
수사관
- 연구 책임자: Ghufran Mfarej, college of dentistry /university of Baghdad
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 1198426
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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