- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02364414
The Accuracy of Direct Digital Intra-oral Scanning Measurements Compared to Measurements on Study Models
The purpose of this study is to compare the accuracy of measurements derived from a commercially available direct intra-oral scanning system with those taken from plaster study models, and to compare cost implications of both systems.
The investigators will test the hypotheses:
- There is no systematic difference between measurements taken from the Trios scanner and study models.
- There is no difference in the cost of producing digital models.
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Northamptonshire
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Kettering, Northamptonshire, 영국, NN16 8UZ
- Kettering General Hospital NHS Foundation Trust
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age range 11 years old to 18 years old.
- Orthodontic patients with a range of malocclusions.
- Dentition without abnormal morphology.
- Adult/permanent dentition from the first molar to first molar in both arches.
Exclusion Criteria:
- Patients under 11 years old and over 18 years old.
- Carious teeth or teeth with significantly altered anatomy.
- Periodontal disease with significant gingival swelling.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: Cohort
Orthodontic patients, aged 11-18 who fulfill the inclusion/exclusion criteria and provide written informed consent to participate will undergo intra-oral scan.
This will be repeated 2 weeks later.
|
Direct intra-oral scan of teeth and dentition
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Measurement of tooth widths, arch lengths, overjet, overbite, crown heights and labio lingual widths
기간: Within six weeks of initial intervention
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All dental study models, and 3D scans will have all the above measurements carried out. There are 22 patients and each will have had study models made and these will be measured twice on two separate occasions, and all scans measured twice. The measurements will be compared and analysed to see if the 3D scans accurately represent the tooth sizes and measurements that have been carried out on the dental study models (gold standard). |
Within six weeks of initial intervention
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Cost
기간: within 6 months of initial intervention
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To determine the difference in cost between the two systems
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within 6 months of initial intervention
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Julian O'Neill, BDS FFDRCS MOrth, Kettering General Hospital NHS Foundation Trust
간행물 및 유용한 링크
일반 간행물
- Santoro M, Galkin S, Teredesai M, Nicolay OF, Cangialosi TJ. Comparison of measurements made on digital and plaster models. Am J Orthod Dentofacial Orthop. 2003 Jul;124(1):101-5. doi: 10.1016/s0889-5406(03)00152-5.
- Han UK, Vig KW, Weintraub JA, Vig PS, Kowalski CJ. Consistency of orthodontic treatment decisions relative to diagnostic records. Am J Orthod Dentofacial Orthop. 1991 Sep;100(3):212-9. doi: 10.1016/0889-5406(91)70058-5.
- Rheude B, Sadowsky PL, Ferriera A, Jacobson A. An evaluation of the use of digital study models in orthodontic diagnosis and treatment planning. Angle Orthod. 2005 May;75(3):300-4. doi: 10.1043/0003-3219(2005)75[300:AEOTUO]2.0.CO;2.
- Fleming PS, Marinho V, Johal A. Orthodontic measurements on digital study models compared with plaster models: a systematic review. Orthod Craniofac Res. 2011 Feb;14(1):1-16. doi: 10.1111/j.1601-6343.2010.01503.x. Epub 2010 Nov 22.
- Cuperus AM, Harms MC, Rangel FA, Bronkhorst EM, Schols JG, Breuning KH. Dental models made with an intraoral scanner: a validation study. Am J Orthod Dentofacial Orthop. 2012 Sep;142(3):308-13. doi: 10.1016/j.ajodo.2012.03.031.
- Bell A, Ayoub AF, Siebert P. Assessment of the accuracy of a three-dimensional imaging system for archiving dental study models. J Orthod. 2003 Sep;30(3):219-23. doi: 10.1093/ortho/30.3.219.
- Lee SP, Delong R, Hodges JS, Hayashi K, Lee JB. Predicting first molar width using virtual models of dental arches. Clin Anat. 2008 Jan;21(1):27-32. doi: 10.1002/ca.20580.
- Machen DE. Legal aspects of orthodontic practice: risk management concepts. The diagnostic dilemma. Am J Orthod Dentofacial Orthop. 1991 Apr;99(4):381-2. doi: 10.1016/s0889-5406(05)81419-2. No abstract available.
- Tomassetti JJ, Taloumis LJ, Denny JM, Fischer JR Jr. A comparison of 3 computerized Bolton tooth-size analyses with a commonly used method. Angle Orthod. 2001 Oct;71(5):351-7. doi: 10.1043/0003-3219(2001)0712.0.CO;2.
- Zilberman O, Huggare JA, Parikakis KA. Evaluation of the validity of tooth size and arch width measurements using conventional and three-dimensional virtual orthodontic models. Angle Orthod. 2003 Jun;73(3):301-6. doi: 10.1043/0003-3219(2003)0732.0.CO;2.
- Quimby ML, Vig KW, Rashid RG, Firestone AR. The accuracy and reliability of measurements made on computer-based digital models. Angle Orthod. 2004 Jun;74(3):298-303. doi: 10.1043/0003-3219(2004)0742.0.CO;2.
- Keim RG, Gottlieb EL, Nelson AH, Vogels DS 3rd. 2008 JCO study of orthodontic diagnosis and treatment procedures, part 1: results and trends. J Clin Orthod. 2008 Nov;42(11):625-40. No abstract available.
- Mayers M, Firestone AR, Rashid R, Vig KW. Comparison of peer assessment rating (PAR) index scores of plaster and computer-based digital models. Am J Orthod Dentofacial Orthop. 2005 Oct;128(4):431-4. doi: 10.1016/j.ajodo.2004.04.035.
- Pani SC, Hedge AM. Impressions in cleft lip and palate--a novel two stage technique. J Clin Pediatr Dent. 2008 Winter;33(2):93-6.
- Sousa MV, Vasconcelos EC, Janson G, Garib D, Pinzan A. Accuracy and reproducibility of 3-dimensional digital model measurements. Am J Orthod Dentofacial Orthop. 2012 Aug;142(2):269-73. doi: 10.1016/j.ajodo.2011.12.028.
- Kachalia PR, Geissberger MJ. Dentistry a la carte: in-office CAD/CAM technology. J Calif Dent Assoc. 2010 May;38(5):323-30.
- Meyer BJ, Mormann WH, Lutz F. [Optimization of the powder application in the Cerec method with environment-friendly propellant systems]. Schweiz Monatsschr Zahnmed. 1990;100(12):1462-8. German.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- Rdb394 v6.1
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