- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02915419
Evaluation of Survival of Mature Second Premolar Treated With Regenerative Techniques
Evaluation of Survival of Mature Second Premolar With Periapical Lesion Following Different Regenerative Treatment Protocols
연구 개요
상세 설명
American Dental Association adopted the tissue engineering concept and pulp regeneration in 2009. Regeneration was focused on the treatment of immature necrotic teeth so as to allow root completion, improving both the functionality and durability of the affected tooth. Utilizing a blood clot in the affected tooth with immature roots was very beneficial, as it acts as a scaffold for the migration of stem cells and morphogens to allow regeneration .
Based on the success of pulp regeneration in treating immature teeth, ambitious dentists started to look forward on regenerating the pulp of mature teeth as a substitution to the conventional root canal treatment. On the other hand, lots of clinicians were very doubtful about treating mature teeth with the same protocol, as the small apical foramen might not provide a good portal for the entry of stem cells and growth factors, which in turn is very important for the success of pulp regeneration.Doubts in treating mature apex encouraged researchers to look for an alternative to the stem cells other than the apical papilla, from this concept the idea for using an alternative source of stem cells and growth factors as platelet rich plasma (PRP) emerged. The use of platelet rich plasma (PRP) as a potentially ideal scaffold for regenerative endodontic therapy has been reported in the treatment of immature teeth. However, the use of bovine thrombin for the activation of PRP has been an issue of controversy, as it requires non autologous anticoagulant known to hinder the process of pulp regeneration.
This led to the development of the second generation, platelet concentrate known as Choukroun's platelet rich fibrin (PRF) which is totally autologous in nature. Platelet rich fibrin (PRF) was very promising, but it is debatable whether to use PRP or PRF.The objective of this study is to evaluate novel regenerative techniques, utilizing platelet rich plasma and platelet rich fibrin in treatment of second premolar teeth with necrotic pulp, mature apex, and periapical lesion. This is a trial to prolong the survival of the affected tooth, and to aid in complete healing of periapical lesion, and to regain pulp vitality and sensitivity.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: wagih ali, ass.lecturer
- 전화번호: 00201065550505
- 이메일: wagihtarek.a@gmail.com
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients who are free from any physical or mental handicapping condition with no underlying systemic diseases.
Non-pregnant females Single canalled second premolar
- Patients having non-vital, mature, second premolar teeth, radiographic evidence of periapical lesion.
- Positive patient/Guardian compliance for participation in the study.
Exclusion Criteria:
- Any known sensitivity or adverse reactions to medicaments or pharmaceuticals necessary to complete the trial.
Non-restorable coronal portion of teeth involved in the trial. Vital teeth Immature teeth Traumatized teeth Radiographic evidence of external or internal root resorption. Any criterion, not mentioned in the inclusion criteria
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: group A
prp revascularization
|
혈소판 풍부 혈장
PLATELET RICH FIBRIN
|
실험적: group B
treatment of affected teeth using platelet rich fibrin by applying prf in steril root canal
|
혈소판 풍부 혈장
PLATELET RICH FIBRIN
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Survival
기간: 1 year
|
how long will the tooth survive after treatment, testing the durability of tooth
|
1 year
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
healing
기간: 1 year
|
measuring the density of lesion using the cone beam CT
|
1 year
|
vitality
기간: 1 year
|
after how many days will the tooth respond normaly to stimulus
|
1 year
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
sensitivity
기간: 1 year
|
after how many days will the tooth respond positively to electric pulp tester
|
1 year
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: wagih ali, ass lecturer, Cairo University
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
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. .
PRP에 대한 임상 시험
-
Sun Yat-sen University알려지지 않은
-
National Defense Medical Center, TaiwanTri-Service General Hospital모병
-
Heba Mohamed Saad EldienM.A. Eloteify; Ahmed Kamal Osman; G.M. Hafsa완전한위축성 흉터