Bone Defects Reconstruction After Dentigerous Cyst Enucleation With Autogenous Demineralized Dentin Matrix- ADDM and Platelet Rich Fibrin- PRF. (Cystregen)
연구 개요
상태
정황
개입 / 치료
- 절차: Impacted third molar extraction with associated dentigerous cyst enucleation- blood clot healing
- 절차: Impacted third molar extraction with associated dentigerous cyst enucleation- regeneration with Advanced Platelet Rich Fibrin
- 절차: Impacted third molar extraction with associated dentigerous cyst enucleation- regeneration with Advanced Platelet Rich Fibrin and Autogenous Demineralized Dentin Matrix
상세 설명
Dentigerous cysts are among the most common odontogenic cysts and are frequently associated with impacted mandibular third molars. Surgical enucleation combined with impacted tooth extraction may result in postoperative bone defects and complications related to tissue healing. Various regenerative approaches have been proposed to improve postoperative healing and bone regeneration following cyst removal.
Advanced platelet-rich fibrin (A-PRF) is an autologous platelet concentrate rich in growth factors that may enhance soft and hard tissue healing. Allogenic dentin-derived matrix (ADDM) has been introduced as a biomaterial supporting bone regeneration and defect filling. However, limited evidence exists regarding their effectiveness following dentigerous cyst enucleation.
This prospective clinical study compares three postoperative management protocols following dentigerous cyst enucleation associated with impacted mandibular third molar extraction: spontaneous blood clot healing, A-PRF application, and A-PRF combined with ADDM.
The primary outcome measure is postoperative bone healing assessed during radiological follow-up. Secondary outcome measures include postoperative pain intensity evaluated using the Numerical Rating Scale (NRS) with graphical representation on the day of surgery and on the second and sixth postoperative day.
The study aims to determine whether regenerative treatment with A-PRF or A-PRF combined with ADDM improves postoperative healing outcomes compared with spontaneous blood clot healing.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Malopolska
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Krakow, Malopolska, 폴란드, 31-155
- Department of Oral Surgery, Institute of Dentistry, Jagiellonian University Medical College
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
Patients diagnosed with dentigerous cysts associated with impacted mandibular third molars Indication for surgical enucleation and tooth extraction Ability to provide informed consent Availability for postoperative follow-up examinations and CBCT assessment
Exclusion Criteria:
Acute local infection at the surgical site Systemic diseases affecting bone healing or tissue regeneration Immunosuppressive therapy Pregnancy or breastfeeding Hematological disorders affecting platelet function, coagulation, or fibrin formation (including thrombocytopenia, coagulopathies, or anticoagulant therapy).
History of radiotherapy in the head and neck region Use of medications affecting bone metabolism Heavy smoking Inability to comply with follow-up visits or postoperative recommendations
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: Blood Clot Healing
Healing of the postoperative defect following enucleation of mandibular dentigerous cyst associated with extraction of impacted mandibular third molar without additional regenerative biomaterials.
|
절차: Impacted third molar extraction with associated dentigerous cyst enucleation- blood clot healing
Surgical extraction of impacted mandibular third molars combines with enucleation of associated dentigerous cysts performed under standarized clinical conditions.
|
|
실험적: A-PRF
Application of advanced platelet rich fibrin (A-PRF) into the postoperative defect following enucleation of mandibular dentigerous cyst associated with extraction of impacted mandibular third molar.
|
Application of autologous advanced platelet rich fibrin (A-PRF) into the postoperative defect following enucleation of mandibular dentigerous cyst and extraction of associated impacted third molar to support regenerative healing.
|
|
실험적: A-PRF + Autogenous Demineralized Dentin Matrix
Application of advanced patelet rich fibrin (A-PRF) combined with autogenous demineralized dentin matrix (ADDM) into the postoperative defect following enucleation of mandibular dentigerous cyst associated with enucleation of impacted mandibular third molars.
|
Application of autologous advanced platelet rich fibrin (A-PRF) and antogenous demineralized dentin matrix (ADDM) into the postoperative defect following enucleation of mandibular dentigerous cyst and extraction of associated impacted third molar to support regenerative healing.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Bone regeneration
기간: 6 and 12 months postoperatively
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Cone- beam computed tomography (CBCT) assessment of bone healing following enucleation of mandibular dentigerous cysts associated with impacted mandibular third molars treated with different regenerative approaches.
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6 and 12 months postoperatively
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Postoperative Pain Intensity
기간: Day of surgery, posteoperative day 2 and 6.
|
Assessment of postoperative pain intensity using the Numerical Rating Scale (NRS, 0-10) with graphic visualization following enucleation of mandibular dentigerous cyst with extraction of associated impacted third molar treated with different regenerative approaches.
|
Day of surgery, posteoperative day 2 and 6.
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Mariusz Szuta, MD, PhD, Department of Oral Surgery, Institute of Dentistry, Jagiellonian University Medical College
- 수석 연구원: Tomasz Kaczmarzyk, Department of Oral Surgery, Institute of Dentistry, Jagiellonian University Medical College
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
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
키워드
기타 연구 ID 번호
- 1072.6120.75.2023
- UJC/W41/NO/28.58 (기타 보조금/기금 번호: University statutory funds)
- UJC/W41/NO/28.40 (기타 보조금/기금 번호: University statutory funds)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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