- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07810465
Evaluation of Occlusal Force Following Rapid Maxillary Expansion Assisted by Piezocision in Different Age Groups
Evaluation of Occlusal Force Following Rapid Maxillary Expansion Assisted by Piezocision in Adolescent Versus Young Adult Orthodontic Patients: A Prospective Clinical Study.
연구 개요
상태
상세 설명
This prospective clinical study evaluates the changes in occlusal force distribution in patients with maxillary transverse deficiency undergoing piezocision-assisted rapid maxillary expansion (RME).
Participants aged 14-22 years with permanent dentition requiring rapid maxillary expansion are allocated into two age-based study groups:
Group I (Adolescents): Patients aged 14-16 years. Group II (Young Adults): Patients aged 18-22 years. All participants undergo piezocision-assisted RME. Under local anesthesia, selective vertical micro-incisions are made interproximally on the buccal alveolar bone distal to the canines, first premolars, and second premolars. Corticotomy cuts to a depth of 3 mm into cortical bone are performed using a piezoelectric surgical device. A bonded tooth-borne Hyrax expander is then cemented and activated two quarters per day (0.5 mm of expansion per day) for 11 days. The expander is maintained as a passive retainer for 3 months to allow stabilization and midpalatal suture remodeling. Primary outcomes evaluate percentage changes in occlusal force distribution at maximum intercuspation across dental arch segments (Anterior vs. Posterior and Right vs. Left), as well as occlusion time and disclusion time during excursive movements, using quantitative digital occlusal force analysis(T-Scan III, Tekscan Inc., Norwood, MA, USA)). Secondary outcomes assess patient-reported pain and discomfort levels at defined time intervals.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Naser City
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Cairo, Naser City, 이집트, 11751
- Department of Orthodontics, Faculty of Dental Medicine, Al-Azhar University
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연락하다:
- Abdulmalek Alqadami, M.Sc. Candidate
- 전화번호: +201555441176 +201553118136
- 이메일: abdulmaliktaw@gmail.com
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연락하다:
- Akram Alqadami, Ph.D. Holder
- 전화번호: +966561010654
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
1 - Patients with transverse maxillary deficiency. 2. Age range 14-22 years 3. Permanent dentition stage. 4. Good general and oral health.
Exclusion Criteria:
- Craniofacial anomalies or syndromes.
- History of orthognathic surgery.
- Periodontal disease or significant bone loss.
- Systemic diseases affecting bone metabolism.
- Previous orthodontic treatment.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Group I: Adolescents
Adolescent patients aged 14-16 years with maxillary transverse deficiency receiving piezocision-assisted rapid maxillary expansion (RME).
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Under local anesthesia using Articaine with 1:100,000 Epinephrine, selective vertical micro-incisions are made interproximally through the attached gingiva to the maximum extent possible using a 15c scalpel blade via a flapless technique, extending through the periosteum to reach the alveolar bone.
Corticotomy cuts are performed using a piezoelectric surgical device with a BS1 Slim II tip to a depth of 3 mm into cortical bone, initiated 2 mm apical to alveolar crest and safely positioned between adjacent tooth roots to avoid iatrogenic injury.
Immediately following surgery, activation of a bonded tooth-borne Hyrax expander commences at a rate of one activation (quarter turn) twice daily (0.5 mm/day) for 11 days, followed by a 3-month passive retention phase for suture remodeling.
다른 이름들:
Quantitative digital measurement of occlusal force parameters using the T-Scan III system (Tekscan, Inc., Norwood, MA, USA) with HD sensors.
Static parameters assessed at Maximum Intercuspation (MIC) include: (1) percentage of force distribution between anterior and posterior teeth, and (2) percentage of force symmetry between right and left arch sides.
Dynamic parameters assessed include: (1) Occlusion Time (OT) measured from initial tooth contact to MIC, and (2) Disclusion Time (DT) recorded during right, left, and protrusive excursive movements.
다른 이름들:
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활성 비교기: Group II: Young Adults
Young adult patients aged 18-22 years with maxillary transverse deficiency receiving piezocision-assisted rapid maxillary expansion (RME).
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Under local anesthesia using Articaine with 1:100,000 Epinephrine, selective vertical micro-incisions are made interproximally through the attached gingiva to the maximum extent possible using a 15c scalpel blade via a flapless technique, extending through the periosteum to reach the alveolar bone.
Corticotomy cuts are performed using a piezoelectric surgical device with a BS1 Slim II tip to a depth of 3 mm into cortical bone, initiated 2 mm apical to alveolar crest and safely positioned between adjacent tooth roots to avoid iatrogenic injury.
Immediately following surgery, activation of a bonded tooth-borne Hyrax expander commences at a rate of one activation (quarter turn) twice daily (0.5 mm/day) for 11 days, followed by a 3-month passive retention phase for suture remodeling.
다른 이름들:
Quantitative digital measurement of occlusal force parameters using the T-Scan III system (Tekscan, Inc., Norwood, MA, USA) with HD sensors.
Static parameters assessed at Maximum Intercuspation (MIC) include: (1) percentage of force distribution between anterior and posterior teeth, and (2) percentage of force symmetry between right and left arch sides.
Dynamic parameters assessed include: (1) Occlusion Time (OT) measured from initial tooth contact to MIC, and (2) Disclusion Time (DT) recorded during right, left, and protrusive excursive movements.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Static Occlusal Force Distribution and Symmetry
기간: Baseline (T0: Pre-expansion) and 3-month post-expansion (T1).
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Percentage of occlusal force distribution between anterior/posterior segments and percentage of force symmetry between right and left sides measured at Maximum Intercuspation (MIC) using T-Scan III.
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Baseline (T0: Pre-expansion) and 3-month post-expansion (T1).
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Dynamic Occlusal Parameters (Occlusion and Disclusion Times)
기간: Baseline (T0: Pre-expansion) and 3-month post-expansion (T1).
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Occlusion Time (OT in seconds, measured from initial tooth contact to Maximum Intercuspation [MIC]) and Disclusion Time (DT in seconds, measured from MIC during lateral and protrusive excursive movements until all posterior teeth completely disclude).
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Baseline (T0: Pre-expansion) and 3-month post-expansion (T1).
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Postoperative Pain and Discomfort
기간: Day 3 (first follow-up), Day 7 (second follow-up), and Day 11 (end of active expansion phase).
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Self-reported pain intensity evaluated using a 10-point Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain).
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Day 3 (first follow-up), Day 7 (second follow-up), and Day 11 (end of active expansion phase).
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
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
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개별 참가자 데이터(IPD) 계획
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IPD 계획 설명
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미국 FDA 규제 기기 제품 연구
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