- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03621163
Copmere Between Bleaching and Laminate Veneers
Shade Evaluation for Clinical Color Change of Discolored Teeth Treated by Bleaching vs Laminate Veneers.
연구 개요
상태
정황
상세 설명
Dental aesthetics, including tooth color, is of great importance for majority of the people and any discoloration or staining can affect their quality of life negatively1,2. In the UK it has been reported that 28% of grownups are dissatisfied with the appearance of their teeth and in the USA that 34% of grownups population are dissatisfied with their current tooth color. Moreover, in a survey of 3215 subjects from the UK 50% have admitted that they had some kind of tooth discoloration3,4.
Tooth bleaching has become one of the most popular aesthetic dental treatments. Because tooth bleaching is an effective, non-invasive procedure for the change of tooth discoloration, it is the best of treatment options for improving teeth color 5.
Ceramic restorations with excellent biocompatibility are widely used to achieve highly aesthetic characteristics in fixed prosthodontics6. Porcelain laminate veneers have become a popular method of treated tooth discoloration. But are expensive, brittle and difficult to repair7.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Patients included in this clinical trial :
- Men and women between 15and 40 years of age.
- Had good general and oral health.
- The participants needed to have six vital maxillary or mandibular anterior teeth without caries lesions or restorations.
- The maxillary canine was shade A3 or darker as judged by comparison with a shade guide (VITA Classical Shade Guide or Spectrophotometer measurement ).
Exclusion Criteria:
Participants were excluded from the study
- If they presented with anterior restorations; had bruxism habits.
- Were pregnant/lactating; presented with non vital tooth discoloration.
- were taking any drug with anti-inflammatory, analgesic, or antioxidant effect; or presented with recession and dentin exposure
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 |
---|---|
실험적: bleaching agent
intervention : bleaching agent ( Boost 40%)
|
Opalescence Boost 40% is a 40% hydrogen peroxide, medical power bleaching gel.
The jet mix syringe ensures freshness for each application and precise dosing of the activator.
One barrel contains a unique chemical activation with sodium fluoride and potassium nitrate, which have been demonstrated to reduce caries susceptibility, lower sensitivity, and improve enamel micro-hardness.
The other barrel contains the concentrated hydrogen peroxide.
When mixed, Opalescence Boost results in a 1.1% fluoride and 3% potassium nitrate concentration.
|
활성 비교기: laminate veneers
laminate veneers ( monolithic lithium - silicate)
|
A lithium-silicate glass ceramic is newly introduced to the market.
After crystallization, it demonstrates an ideal combination of strength, aesthetics and translucency that mirrors the vitality of natural teeth for fabrication of full anatomic anterior and posterior crowns.
It differentiated from other ceramics by its high chipping resistance, due to their monolithic composition and average flexural strength of 385 MPa.
Also Milling Block has good wear resistance due to the high content of ultra-fine nano-meter size crystalline structure.
Lithium-silicates ceramic blocks are available in the commonly used VITA Classical and Chromascop Bleach shades.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Color change.
기간: 1-4 weeks
|
measures the change of color before and after intervention by Easy Shade Spectrophotometry
|
1-4 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Corresponding color with comparator.
기간: 1-4 weeks
|
by Digital photographs
|
1-4 weeks
|
공동 작업자 및 조사자
스폰서
간행물 및 유용한 링크
일반 간행물
- Gupta SK, Saxena P. Evaluation of patient satisfaction after non-vital bleaching in traumatized discolored intact anterior teeth. Dent Traumatol. 2014 Oct;30(5):396-399. doi: 10.1111/edt.12109. Epub 2014 Apr 10.
- Gerlach RW, Zhou X. Clinical trial comparing two daytime hydrogen-peroxide professional vital-bleaching systems. Compend Contin Educ Dent. 2004 Aug;25(8 Suppl 2):33-40.
- Almeida LC, Riehl H, Santos PH, Sundfeld ML, Briso AL. Clinical evaluation of the effectiveness of different bleaching therapies in vital teeth. Int J Periodontics Restorative Dent. 2012 Jun;32(3):303-9.
- Mountouris G, Mantzavinos Z, Michou H. [Discolorations: a new method of bleaching discolored vital teeth. (Preliminary study)]. Odontostomatol Proodos. 1990 Jun;44(3):195-206. Greek, Modern.
- Marson FC, Sensi LG, Vieira LC, Araujo E. Clinical evaluation of in-office dental bleaching treatments with and without the use of light-activation sources. Oper Dent. 2008 Jan-Feb;33(1):15-22. doi: 10.2341/07-57.
- Alomari Q, El Daraa E. A randomized clinical trial of in-office dental bleaching with or without light activation. J Contemp Dent Pract. 2010 Jan 1;11(1):E017-24.
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
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 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. .
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