Using Buccal Pad of Fat Free Tissue Transfer With Immediate Implant Placement
Evaluation of Using Buccal Pad of Fat Free Tissue Transfer With Immediate Implant Placement in the Maxillary Posterior Area
Implants placed immediately after tooth extraction usually present challenges in obtaining soft tissue coverage with high risk of bacterial invasion, wound dehiscence and subsequently adverse effect on the success rate of the implant due to lack of primary soft tissue closure over the implant.
Different surgical methods have been described to achieve primary soft tissue closure in maxillary fresh socket, each having its advantages and disadvantages, based on that, buccal pad of fat can solve this soft tissue coverage problem with minimal complications and high success rate of the placed implants.The objective of this study is to evaluate the use of buccal pad of fat tissue with immediate implant placement in the posterior maxillary area.
연구 개요
상세 설명
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 age between 20-45 years with no gender predilection.
- Patients with non-restorable maxillary posterior tooth which need to be extracted (premolar -molar region).
- Patients with good oral hygiene.
- Bony defects more than 2 mm during implant placement treated by bone substitute.
- Patients fully capable to comply with the study protocol.
Exclusion Criteria:
- Patients with any systemic disease affecting bone quality as uncontrolled diabetes.
- Heavy smokers (more than 20 cigarettes per day).
- Sites with acute oral infection.
- Pregnant and lactating patients.
- Untreated periodontal disease.
- Previous chemotherapy or irradiation of the head and neck.
- Inadequate interocclusal space.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Intervention group
10 patients will have immediate implant placement with buccal pad of fat free tissue
|
Xenograft bone substitute will be placed over the implant to cover the bone defect after extraction.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Evaluate postoperative pain when using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area.
기간: 6 months
|
Postoperative pain will be recorded by each patient after 2, 6, and 12 hours postoperatively, then daily for the first week using: a 10-point Visual Analogue Scale (VAS) (17) from 0 to 10 (0 no pain, to 10 severe pain). |
6 months
|
|
Evaluate swelling when using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area.
기간: 6 months
|
Postoperative swelling will be recorded by each patient after 2, 6, and 12 hours postoperatively, then daily for the first week using a 10-point scale with 4 parameters will be used: none (no swelling), light (intraoral, localized to the treated area), moderate (extraoral swelling localized to the treated area), and severe (extraoral swelling extending beyond the treated area)
|
6 months
|
|
Evaluate soft tissue healing when using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area.
기간: 6 months
|
Evaluation of soft tissue healing At week 1, week4 and at 6 months: Presence/absence of postoperative complications will be evaluated, including: Bleeding, hematoma, wound dehiscence, local infection, partial flap necrosis, excessive granulation tissue or vestibular obliteration, edema, facial asymmetry and mouth opening limitation. |
6 months
|
|
Evaluate implant stability when using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area
기간: 6 months
|
Implant stability will be measured by implant stability meter (OsstellTM), immediately postoperative and after 6 months.
|
6 months
|
|
Radiographic evaluation for using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area.
기간: 6 months
|
After 3 months then at 6 months Cone Beam CT will be requested in order to measure:
|
6 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Lobna Elwan, BSc, Alexandria University
- 연구 책임자: Nagy El Prince, PhD, Alexandria University
- 연구 책임자: Ahmed O. Swedan, PhD, Alexandria University
간행물 및 유용한 링크
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. .
치과 임플란트에 대한 임상 시험
-
Cairo University아직 모집하지 않음
Xenograft bone substitute (Osteo-biol)에 대한 임상 시험
-
Andrea RavidaSigmaGraft Inc.초대로 등록
-
Kansas Joint and Spine InstituteISTO Technologies, Inc.; National Center of Innovation for Biomaterials in Orthopaedic...알려지지 않은