- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02652403
Simplified Versus Conventional Technique for Complete Denture Fabrication.
Quality of Life, Patient Satisfaction, Quality of Dentures, Masticatory Efficiency, Presence of Temporomandibular Dysfunction and Costs Analysis of Simplified and Conventional Techniques for Complete Denture Fabrication
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 2 단계
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Edentulous individuals for more than one year and total bimaxillary prosthesis users that need a couple of new prostheses.
Exclusion Criteria:
Pathological changes of alveolar ridges, motor problems and systemic diseases that may influence on the individual's adaptation to the prosthesis.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Complete conventional dentures
Complete dentures fabricated by conventional technique.
|
The typical operations of conventional technique will be carried out dentures fabrication and clinical appointments and laboratory steps will be necessary until denture insertion: Preliminary impression using irreversible hydrocolloid in a stock trays; Individual acrylic resin trays fabrication; Functional impressions using Zinc oxide-eugenol paste and low fusion compound in a individual acrylic resin trays; Maxillary occlusion rims fabrication; Maxillary occlusion rims fabrication adjustments, Centric relation records and transference of the maxillary occlusion rims positions to semiadjustable articulators using a facebow; Setting of teeth in wax; Complete denture wax try-in; Insertion, instructions and postinsertion appointments.
다른 이름들:
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|
활성 비교기: Complete simplified dentures
Complete dentures fabricated by simplified technique
|
For a complete simplified denture fabrication, individual acrylic resin trays fabrication and functional impressions steps will be deleted, and the facebow for transference of the maxillary occlusion rims positions to semiadjustable articulators will be replaced by the table Camper.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Quality of life
기간: Baseline = day 0
|
To assess the impact of oral health on quality of life individuals will be used the Brazilian version of Oral Health Impact Profile for edentulous patients (OHIP-Edent).
The inventory shall be applied by a masked examiner.
|
Baseline = day 0
|
|
Patient satisfaction
기간: Baseline = day 0
|
Patient satisfaction about complete dentures will be access using a questionnaire that assesses aspects related to overall quality of prosthesis, as well as comfort, aesthetics, retention, phonetics and mastication.
|
Baseline = day 0
|
|
Masticatory efficiency
기간: Three months
|
The evaluation of the masticatory efficiency will be conducted through chewing capsules.
|
Three months
|
|
Quality of life
기간: Three months
|
To assess the impact of oral health on quality of life individuals will be used the Brazilian version of Oral Health Impact Profile for edentulous patients (OHIP-Edent).
The inventory shall be applied by a masked examiner.
|
Three months
|
|
Patient satisfaction
기간: Three month
|
Patient satisfaction about complete dentures will be access using a questionnaire that assesses aspects related to overall quality of prosthesis, as well as comfort, aesthetics, retention, phonetics and mastication.
|
Three month
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Costs analysis
기간: Baseline = day 0
|
Assessment of the costs involved in the dentures fabrication will be calculated according to the methodology applied by Takanashi et al. 2004.
|
Baseline = day 0
|
|
Quality of dentures
기간: Three months
|
Assessment of the technical quality of dentures will be done using an examination that analyzes 14 variables: Selection of artificial teeth; Arrangement of the anterior teeth; Interocclusal distance; Stability of the upper and lower prosthesis; Language space; Centric occlusion; Occlusion during the excursive movements; Retention of upper and lower dentures; Edge of the upper prosthesis extension; Edge of the lower prosthesis extension; facets; Positioning of the posterior teeth.
|
Three months
|
|
Temporomandibular dysfunction
기간: Baseline = day 0
|
To evaluate the presence of TMD, all subjects will be assessed through RDC / TMD translated and validated to Portuguese by a masked examiner.
|
Baseline = day 0
|
|
Temporomandibular dysfunction
기간: Three month
|
To evaluate the presence of TMD, all subjects will be assessed through RDC / TMD translated and validated to Portuguese by a masked examiner.
|
Three month
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Patricia dos Santos Calderon, Doctor, Universidade Federal do Rio Grande do Norte
간행물 및 유용한 링크
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 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .