Evaluation of a New Design of Crowns in the Posterior Teeth
Evaluation of IPS E.Max-CAD Endocrown in Molars Compared to the Conventional Design
Background: no randomized controlled trial has tried to compare treatment outcomes between the IPS.emmax endocrowns and the IPS.emmax conventional crowns .
Objective: to investigate the clinical performance of the IPS.emmax endocrowns and the IPS.emmax conventional crowns Design and setting: Parallel-groups randomized controlled trial on patients with one or more intensive damaged molars requiring crowning and being treated at the University of Damascus, Dental School in Damascus, Syria .All molars will be examined at the baseline assessment using a modified US Public Health Service (USPHS) criteria.
Participants: Incoming patients to the Fixed Prosthetic and Endodontic Departments will be examined to find any excessively damaged molars requiring crowning. Forty patients will be recruited according to specific inclusion criteria. Randomization will be performed using computer-generated tables; allocation will be concealed using sequentially numbered opaque and sealed envelopes.The included 40 patients will be analyzed (age range between 20-60 years). They will be randomly distributed into two groups with 20 patients in each group (1:1 allocation ratio).
Intervention: Excessively damaged and endodontically treated molars will be restored with IPS.emmax endocrowns or IPS.emmax crowns supported with composite core.
Main outcome measure: marginal adaptation and anatomic form will be investigated clinically and by apical radiographs at the baseline assessment using the modified (USPHS) at six assessment times during an 18-month observation period.
Assessor blinding will be employed.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Damascus, 시리아 아랍 공화국, DM20AM18
- Department of Fixed Prosthodontics, University of Damsacus
-
Damascus, 시리아 아랍 공화국, DM20AM18
- University of Damascus Dental School
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients between 20 to 60 years old
- Good oral hygiene
- Gingival index (GI) equal 0
- Plaque index (PI) equal 0 or 1
- Primary acceptation and commitment to the trail
Inclusion criteria of molars:
- Two remaining axial walls at least.
- 0.5 mm above the gingival line at least for damaged axial walls.
- Good endodontic treatment and apical seal
- First and second upper and lower molars only.
- Against teeth could be natural or crowned.
Exclusion Criteria:
- Patients with an open bite or cross bite.
- Bruxism
- Periodontitis
- Gingival hyperplasia
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
간섭 없음: IPS.emmax crown
|
|
|
실험적: IPS.emmax endocrown
Patients with excessively undermined and endodontically treated molars will receive the IPS.emmax endocrown as the restoration of choice.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Marginal Adaptation
기간: at 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 15 months (T5), and 18 months (T6) following application
|
The presence of marginal adaptation means that the restoration margins cannot be distinguished, the probe cannot find a step between the margins and the surrounding tissue, and no discoloration visible.
|
at 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 15 months (T5), and 18 months (T6) following application
|
|
Change in the Anatomic Form
기간: at 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 15 months (T5), and 18 months (T6) following application
|
The anatomic form is considered satisfactory when the crown has a correct contour with tight proximal contact, no worn facets on restorations and no worn facets on opposing teeth.
|
at 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 15 months (T5), and 18 months (T6) following application
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in the Retention Status
기간: at 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 15 months (T5), and 18 months (T6) following application
|
Retention loss is considered when the crown becomes loose or mobile.
|
at 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 15 months (T5), and 18 months (T6) following application
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Rana Dallool, DDS, University of Damascus Dental School
간행물 및 유용한 링크
일반 간행물
- Bernhart J, Brauning A, Altenburger MJ, Wrbas KT. Cerec3D endocrowns--two-year clinical examination of CAD/CAM crowns for restoring endodontically treated molars. Int J Comput Dent. 2010;13(2):141-54. English, German.
- Biacchi GR, Basting RT. Comparison of fracture strength of endocrowns and glass fiber post-retained conventional crowns. Oper Dent. 2012 Mar-Apr;37(2):130-6. doi: 10.2341/11-105-L. Epub 2011 Sep 26.
- Bindl A, Mormann WH. Clinical evaluation of adhesively placed Cerec endo-crowns after 2 years--preliminary results. J Adhes Dent. 1999 Autumn;1(3):255-65.
- Fischer H, Marx R. Fracture toughness of dental ceramics: comparison of bending and indentation method. Dent Mater. 2002 Jan;18(1):12-9. doi: 10.1016/s0109-5641(01)00005-7.
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
- UDDS-FixPro-01-2014
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. .
Broken Down Molars에 대한 임상 시험
-
Centre National d'Etudes SpatialesEuropean Space Agency; MEDES - IMPS모집하지 않고 적극적으로무중력 | Head Down Tilt Bedrest를 통한 미세중력 시뮬레이션프랑스