Prevention of Mandibular Third Molar Extraction- Associated Periodontal Defects Using Platelet-Rich Fibrin
연구 개요
상세 설명
Eighteen young patients with bilateral impacted mandibular third molars will be selected. All 36 cases of impactions will be selected for a split mouth study and randomly treated by using 2 different therapeutic approaches, thereby yielding 2 different study groups, each of which is composed of 18 cases: in one side the post-extraction socket is left healing spontaneously, on the other side the socket is filled with PRF.
CAL at the distal surface of the lower second molar is chosen as primary outcome.
Criteria will be the presence of a pocket distal to the mandibular second molar with a probing depth >7 mm and a probing clinical attachment level >6mm.
This study was designed as a single-blind research since subjects will be unaware of their treatment allocation. A software will be used to produce a random sequence of 18 integer numbers without duplicates generated from atmospheric noise and concealed in closed envelopes by one of the investigators. At the time of the patient's first surgery, the envelope will be opened and patient allocated either to group 1 (PRF on the right side, spontaneous healing on the left side), for allocation numbers 1-9, or group 2 (spontaneous healing on the right side, PRF on the left side), for allocation numbers 10-18.
One clinician, not involved in patient treatment and not aware of what therapeutic approach used for the different sites of treatment, will perform all clinical measurements (PD, CAL, gingival recession, plaque index and gingival bleeding index) before and after 12 and 18 weeks of surgery.
Clinical and radiographical measurements will be recorded at 12 and 18 weeks after the surgery. The Student t test will be used to compare the differences between the 2 groups.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Naples, 이탈리아, 80131
- Gilberto Sammartino
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion criteria Patients of both genders and any race, between 18 and 35 year-old
- Periodontally health patients and treated periodontally compromised patients
- Enrollment on a regular supportive periodontal therapy (SPT) program.
- Full-mouth plaque score (FMPS)< 25% at baseline;
- Full-mouth bleeding score (FMBS)< 25% at baseline;
- Patients having bilateral mesioangular impacted mandibular third molars with the presence of a pocket distally to the mandibular second molar with a probing depth (PD) ≥7 mm
- Intact buccal and lingual cortical bone of the post-extraction site
Exclusion Criteria:
- General contra-indications for surgery (systemic disease, compromised immune system etc);
- Tobacco smoking
- Pregnancy and lactation
- Untreated periodontal conditions;
- Acute infection in the site of the extraction
- Patients taking any medications which might interfere with coagulation
- Platelet count < 150000/mm3
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: PRF (platelet-rich fibrin)
PRF will be used after the extraction of the third molar to prevent periodontal defects to second molar
|
After loco-regional anesthesia was administered, a full-thickness mucoperiosteal flap was raised.
The flap incision was extended from the vestibular side of the retromolar trigon to the second molar, corresponding to its distolingual cusp.
The incision continued intrasulcular at the second molar and proceeded with a release incision distally to the papilla between the first and second molars, on a 45° angle.
An osteotomy using a Lindemann burr under constant irrigation, followed by an odontotomy using a diamond burr was performed, if necessary
|
|
활성 비교기: spontaneous healing
after the extraction of the third molar the socket will be left to heal spontaneously
|
After loco-regional anesthesia was administered, a full-thickness mucoperiosteal flap was raised.
The flap incision was extended from the vestibular side of the retromolar trigon to the second molar, corresponding to its distolingual cusp.
The incision continued intrasulcular at the second molar and proceeded with a release incision distally to the papilla between the first and second molars, on a 45° angle.
An osteotomy using a Lindemann burr under constant irrigation, followed by an odontotomy using a diamond burr was performed, if necessary
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Clinical attachment level change
기간: 12 and 18 weeks
|
the clinical attachment level is the distance between the gingival margin to the cemento-enamel junction. the measurement is made by using a Williams periodontal probe. Differences in changes are measured from baseline to 12 and 18 weeks. |
12 and 18 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
probing depth change
기간: 12 and 18 weeks
|
The probing depth is the distance from the free end of the gingival margin to the bottom of the periodontal pocket.
The measurement is made by using a Williams periodontal probe.
Differences in changes are measured from baseline to 12 and 18 weeks.
|
12 and 18 weeks
|
|
gingival recession change
기간: 12 and 18 weeks
|
The distance between the cemento-enamel junction and gingival margin gives the level of recession. The measurement is made by using a Williams periodontal probe. Differences in changes are measured from baseline to 12 and 18 weeks. |
12 and 18 weeks
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Gilberto Sammartino, Professor, Federico II University
간행물 및 유용한 링크
일반 간행물
- Cabaro S, D'Esposito V, Gasparro R, Borriello F, Granata F, Mosca G, Passaretti F, Sammartino JC, Beguinot F, Sammartino G, Formisano P, Riccitiello F. White cell and platelet content affects the release of bioactive factors in different blood-derived scaffolds. Platelets. 2018 Jul;29(5):463-467. doi: 10.1080/09537104.2017.1319046. Epub 2017 Jun 21.
- Sammartino G, Dohan Ehrenfest DM, Carile F, Tia M, Bucci P. Prevention of hemorrhagic complications after dental extractions into open heart surgery patients under anticoagulant therapy: the use of leukocyte- and platelet-rich fibrin. J Oral Implantol. 2011 Dec;37(6):681-90. doi: 10.1563/AAID-JOI-D-11-00001. Epub 2011 Jun 30.
- Sammartino G, Tia M, Marenzi G, di Lauro AE, D'Agostino E, Claudio PP. Use of autologous platelet-rich plasma (PRP) in periodontal defect treatment after extraction of impacted mandibular third molars. J Oral Maxillofac Surg. 2005 Jun;63(6):766-70. doi: 10.1016/j.joms.2005.02.010.
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 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. .