- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07705009
Intraoral Scanning Versus Alginate Impressions in Dental Students
Procedure Time and Patient Comfort of Intraoral Scanning Versus Alginate Impressions Among Dental Students: A Randomized Clinical Trial
Dental impressions are used to create a record of a person's teeth and oral structures. Conventional impressions are made using impression material placed in a tray, whereas digital impressions are obtained using an intraoral scanner.
This randomized clinical trial compared conventional alginate impressions with digital intraoral scanning using the TRIOS 3 and Medit i700 scanners among dental students aged 18 to 24 years. Participants were randomly assigned to one of the three impression techniques. Each participant underwent recording of both the upper and lower dental arches using the assigned technique.
The study primarily compared the chairside time required for each technique and the participants' experience immediately after the procedure. Comfort, nausea, breathing, pain, dry-mouth sensation, perceived procedure speed, overall satisfaction, and preference for conventional or digital impressions were also evaluated.
연구 개요
상태
정황
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Huế, 베트남, 530000
- Faculty of Odonto-Stomatology, University of Medicine and Pharmacy, Hue University
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Undergraduate dental students at the University of Medicine and Pharmacy, Hue University.
- Aged 18 to 24 years.
- Willing to undergo one maxillary and one mandibular dental impression using the assigned technique.
- Willing and able to complete the study questionnaire.
- Provided written informed consent.
Exclusion Criteria:
- Currently undergoing orthodontic treatment.
- Presence of a systemic disease or acute condition that limited the ability to cooperate or increased the risk of discomfort during impression taking or intraoral scanning, including an acute respiratory disorder or frequent vomiting.
- Limited mouth opening or an oral and maxillofacial condition that prevented correct impression-tray seating or scanner-tip placement according to the study protocol.
- A maxillofacial abnormality that markedly affected the procedure or caused significant recording distortion.
- An excessive gag reflex that prevented completion of the assigned procedure.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Conventional Alginate Impression
Participants underwent maxillary and mandibular conventional impressions using alginate impression material and stock trays according to the manufacturer's instructions.
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Maxillary and mandibular conventional impressions were obtained using Tropical alginate impression material and stock trays.
The alginate was mixed, placed in the impression tray, and used according to the manufacturer's instructions.
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실험적: TRIOS 3 Intraoral Scanning
Participants underwent full-arch maxillary and mandibular digital impressions and bite registration using the TRIOS 3 intraoral scanner according to the manufacturer's recommended scanning protocol.
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Maxillary and mandibular full-arch digital impressions were obtained using the TRIOS 3 intraoral scanner according to the manufacturer's recommended scanning protocol.
A bite-registration scan was also obtained.
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실험적: Medit i700 Intraoral Scanning
Participants underwent full-arch maxillary and mandibular digital impressions and bite registration using the Medit i700 intraoral scanner according to the manufacturer's recommended scanning protocol.
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Maxillary and mandibular full-arch digital impressions were obtained using the Medit i700 intraoral scanner according to the manufacturer's recommended scanning protocol.
A bite-registration scan was also obtained.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Total Chairside Procedure Time
기간: During the assigned impression procedure at the single study visit
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Total chairside procedure time was measured in seconds using a digital stopwatch and calculated as the sum of the recorded procedural stages.
For the conventional alginate group, the stages included maxillary mixing, maxillary impression taking, mandibular mixing, and mandibular impression taking.
For the digital groups, the stages included patient and case information entry, maxillary scanning, and mandibular scanning.
Bite-registration time was excluded from the total procedure time because there was no equivalent stage in the conventional alginate workflow.
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During the assigned impression procedure at the single study visit
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Patient-Reported Overall Comfort During the Impression Procedure
기간: Immediately after completion of the assigned impression procedure
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Overall comfort during the assigned impression procedure was assessed immediately after the procedure using a 0-to-100 visual analogue scale.
Higher scores indicated greater comfort.
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Immediately after completion of the assigned impression procedure
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공동 작업자 및 조사자
수사관
- 수석 연구원: Van Nhat Thang Le, DDS PhD, Faculty of Odonto-Stomatology, University of Medicine and Pharmacy, Hue University
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
- H2025/074
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
미국에서 제조되어 미국에서 수출되는 제품
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