A 14 Weeks Longitudinal Study to Investigate the Effect of Leukocyte- Platelet Rich Fibrin Plug on the Quality of the Newly Formed Bone in Ridge Preservation Procedure Following a Tooth Extraction. It is a Clinical, Radiographic and Histomorphometric Study.
Ridge Preservation With Leukocyte Platelet Rich Fibrin: A Clinical, Radiographic, and Histomorphometric Study.
This 14 weeks longitudinal study will be conducted from March 2018 to June 2020, with a 40 participants. No subjects has received placebo medication at any point in the research procedures.
Null hypothesis: The use of L-PRF plug, in combination with non-resorbable, open barrier membrane technique to fill the extraction sockets will have no effect on the quality of the newly formed bone nor on the dimensional changes of the ridge, compared to non-resorbable, open barrier membrane technique with natural blood clot.
연구 개요
상태
상세 설명
This 14 weeks longitudinal study was conducted from March 2018 to June 2020, with a 27 participants. No subjects has received placebo medication at any point in the research procedures.
The proposed sample population has been recruited from the patient population of the University of Kentucky College of Dentistry clinics and the patient must have had an unsalvageable tooth that was planned for extraction and delayed implant placement and was assigned into a control group and a test group by chance. Fifteen extraction socket sites of the test group were filled with autogenous L-PRF Plug (Intralock) and d-PTFE membrane (Cytoplast) was laid on the top to seal the extraction socket. In the control group, d-PTFE membrane (Cytoplast) was laid on the top of twelve extraction sockets to allow natural blood clot formation in the extraction socket.
The primary aim is to assess the quality of the newly formed bone at 14 weeks the time of implant placement by comparing the percentage of new vital bone in the histomorphometric analysis. The second aim was to assess the horizontal and vertical changes of the residual bony ridge using Cone Bean Computerized Tomography (CBCT) analysis at baseline immediately after tooth extraction at 12 weeks of healing.
Null hypothesis: The use of L-PRF plug, in combination with non-resorbable, open barrier membrane technique to fill the extraction sockets will have no effect on the quality of the newly formed bone nor on the dimensional changes of the ridge, compared to non-resorbable, open barrier membrane technique with natural blood clot.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Kentucky
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Lexington, Kentucky, 미국, 40536
- Univerisity of Kentucky College of Dentistry
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- The subject must have an unsalvageable tooth that is planned for extraction and delayed implant placement.
- The tooth should be free of acute odontogenic infections.
- Extraction sockets with minimal to moderate bony defect.
Exclusion Criteria:
- Any patient who is planned for full mouth extraction.
- Heavy smoker (more than 10 cigarettes a day).
- History of malignancy, chemotherapy, radiation therapy.
- Immunosuppressive disease.
- Uncontrolled systemic disease.
- Any contraindications to surgical procedures.
- Females who are pregnant or breastfeeding.
- For multi-rooted teeth, if the most coronal part of the interradicular septum is less than 5 mm below the crest of the bone.
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 |
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활성 비교기: Control group
Under the effect of local anesthetic tooth will be extracted then a d-PTFE membrane will be used to cover the socket without any bone graft material to preserve the ridge.
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Following tooth extraction, the socket will be covered with a d-PTFE membrane
다른 이름들:
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실험적: Test group
Under the effect of local anesthetic tooth extraction will be followed by the collection of about 50 ml of the patient's venous blood, then without adding any anticougulant the blood will be spun to make a plug.
The Leukocyte platelet rich fibrin plug + d-PTFE membrane will be used to preserve the ridge.
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Following tooth extraction, an autologous leukocyte platelet rich fibrin plug will be placed in the socket and covered with a d-PTFE membrane
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Quality of the Newly Formed Bone
기간: The bone sample was harvested at 14 weeks from the baseline visit (extraction of tooth).
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Histomorphometric analysis will be performed on a bone core sample harvested at the time of implant placement.
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The bone sample was harvested at 14 weeks from the baseline visit (extraction of tooth).
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Dimensional Changes of the Alveolar Ridge (Ridge Width)
기간: The baseline CBCT after tooth extraction and 12 weeks CBCT after extraction.
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Two Cone Bean Computerized Tomography (CBCT) measurements were compared to perform the analysis.
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The baseline CBCT after tooth extraction and 12 weeks CBCT after extraction.
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Mhdfiras Al Yafi, DDS, University of Kentucky College of Dentistry
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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 연구와 관련된 용어
기타 연구 ID 번호
- 17-0815-F2L
개별 참가자 데이터(IPD) 계획
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