- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07826182
Comparison Between Two Different Loops for Maxillary Canine Retraction
Comparison Between Two Different Loops for Maxillary Canine Retraction (Split Mouth Technique)(Randomized Clinical Study)
연구 개요
상세 설명
Orthodontic management of severe dental crowding and dentoalveolar protrusion frequently necessitates the extraction of maxillary first premolars. Following extraction, space closure is typically executed in a two-step procedure, initiated by isolated canine retraction to provide adequate space for subsequent incisor alignment and retraction.
Because canine retraction spans the longest duration of the space-closure phase, optimizing this stage is critical to achieving rapid, controlled tooth movement while minimizing adverse clinical effects like anchorage loss, root resorption, and unwanted tooth tipping or rotation.
In clinical orthodontics, canine retraction can be achieved through two primary biomechanical modalities: friction (sliding) mechanics and frictionless (loop/sectional) mechanics. While sliding mechanics are highly valued for their clinical simplicity, they generate significant frictional forces and binding at the bracket-arch wire interface. This friction can dissipate a substantial portion of the applied orthodontic force, cause unpredictable tooth movement and increase the risk of posterior anchorage strain. Conversely, frictionless mechanics eliminate these interface variables by utilizing specialized sectional wire loops to generate the required forces.
The success of frictionless canine retraction relies heavily on the structural design and configuration of the loop used.
Different loop designs such as the classic Burstone T-loop, the Opus loop, and the modified Marcotte spring exhibit distinct biomechanical properties:
- Load-Deflection Rate (LDR): Determines how rapidly the force decays as the tooth moves. A lower LDR provides a safer, more constant force over time.
- Moment-to-Force (M: F) Ratio: Governs the type of tooth movement achieved. Achieving a precise M:F ratio is mandatory to prevent uncontrolled distal tipping and promote controlled tipping or bodily movement (translation).
Despite extensive laboratory and limited element analyses detailing the theoretical behavior of various loop designs, translating these findings into real-world performance remains challenging. Individual biological variations such as; bone remodeling rates, alveolar bone density, and patient compliance introduce confounding variables that can twist clinical outcomes in traditional parallel-group clinical trials. To overcome these biological limitations, a split-mouth study design serves as an ideal methodology.
By randomly assigning different loop mechanics to opposing quadrants within the same maxillary arch of a single patient, each subject acts as their own perfectly matched control, effectively eliminating systemic biological bias. Recent clinical trials utilizing this design have started to clarify differences in loop efficiency.
For instance, comparisons between the Opus loop and the T-loop have demonstrated subtle variations in retraction rates, though both maintain comparable overall clinical performance.
Similarly, investigations contrasting the T-loop against alternative segmental systems, such as dual-force retractors or modified Marcotte springs, emphasize that loop configuration directly influences the duration of retraction, three-dimensional torque control, and the preservation of posterior anchorage.
While several clinical trials have compared sliding versus loop mechanics, head-to-head clinical comparisons evaluating efficiency, anchorage control, rotational tendencies, and patient comfort levels between different modern loop designs remain scarce. Consequently, there is an ongoing clinical debate regarding which loop configuration yields the most favorable balance between rapid canine retraction and optimal three-dimensional position control.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Fayrouz Fayrouz Esam Ahmed Taher Mahmoud
- 전화번호: 0201016926903
- 이메일: fayrouzesam17@gmail.com
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Adults aged 16-25 years.
- Class I or II div 1 malocclusion with moderate to severe crowding who are indicated for maxillary premolar extraction.
- Good oral hygiene and general health.
- Full eruption of maxillary permanent canines and second molars.
Exclusion Criteria:
- Systemic disease affecting bone remodeling eg.DM
- Previous extraction of permanent teeth.
- Periodontal disease or radiographic evidence of bone loss.
- Previous orthodontic treatment.
- Craniofacial anomalies or cleft lip and palate.
- Skeletal asymmetry.
- Orthodontic cases that could be treated with no indication for extraction
- Orthodontic cases that are indicated for extraction of any tooth other than maxillary first premolars.
공부 계획
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디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Poul Gjessing (PG) Loop
orthodontic patient treated by Poul Gjessing (PG) spring for canine retraction.
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orthodontic patient treated by Poul Gjessing (PG) spring for canine retraction.
|
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실험적: Modified Marcotte Loop
orthodontic patient treated by modified Marcotte spring for canine retraction.
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orthodontic patient treated by Modified Marcotte spring for canine retraction.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Maxillary Canine Retraction
기간: At the baseline visit (T-0), a dental impression and a CBCT scan will be obtained. For intermediate follow-up visits at months 1 through 5 (T-1 to T-5), dental impressions only will be recorded. At the final 6-month visit (T-6), both a dental impression
|
At the baseline visit (T-0), a dental impression and a CBCT scan will be obtained. For intermediate follow-up visits at months 1 through 5 (T-1 to T-5), dental impressions only will be recorded. At the final 6-month visit (T-6), both a dental impression
|
공동 작업자 및 조사자
스폰서
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
이 연구와 관련된 용어
기타 연구 ID 번호
- Canine Retraction with Loops
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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