Clinical, Radiographical, Histological Evaluation and Blood Flow Analysis of Hard- and Soft- Tissue Changes Following Alveolar Ridge Preservation
试验速览
- 阶段
- 不适用
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Horizontal ridge width changes
研究概览
简要总结
With alveolar ridge preservation (ARP) ridge resorption following extraction may be reduced. Several materials and techniques have been advocated for ARP. The aim of our randomised clinical trial is to evaluate the efficacy of extraction side development technique (XSD) and autogenous tooth bone graft (ATB) for ARP.
详细描述
A three armed clinical study will be established. According to the sample size calculation, every arm will contain 21 participants. The first group is the socket seal group. In the second group we aim to combine the socket seal and XSD technique. In the third group the XSD technique will be combined with the ATB material. The primary outcome is the alveolar ridge width change in millimeter, measured immediately after the tooth extraction and after 6 months at the reentry procedure. The change in alveolar ridge width and vertical dimensional alterations will be also measured as secondary outcomes on the CBCT at baseline and after 6 months. Further secondary outcomes are the monitoring of gingival microvascularization, monitoring of flap revascularization by Laser Speckle Contrast Imaging and assessment of soft tissue volumetric changes by intraoral scanning and histomorphometric evaluation of the volumetric percentage of newly formed bone, connective tissue and graft material after a 6-month healing period in a core biopsy taken at the time of implant placement.
Hypothesis
The XSD and XSD+ATB groups are expected to have less pronounced horizontal width losses. XSD group is expected to produce the highest graft turnover.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Women and men Patients over 18 years Co-operative patients with good individual oral hygiene (FMBS: 25%>) Patients with periodontal disease in treatment or under treatment with minimal active inflammation (FMPS: 25%>)
- •Local criteria:
- •Teeth with a hopeless prognosis with advanced periodontal or endo-periodontal defects, which are restored with implant prosthesis EDS 3-4 extraction defects after tooth extraction
排除标准
- •Infectious diseases (HBV, HCV, HIV, CoV-2019…) Current chemotherapy or radiotherapy Previous radiation therapy to the head and neck region (in the last 2 years) Untreated insulin dependent diabetes mellitus Clinically significant osteoporosis or other systemic disease affecting bone metabolism Clinically significant circulatory disorder e.g.: decompensated cardiac failure Haemodynamically significant valvular heart failure or myocardial infarction within the last 3 months Clinically significant coagulopathy Current or previous systemic corticosteroid therapy (in the last 2 months) Current or previous systemic bisphosphonate therapy (beyond 30 days) Pregnant or breastfeeding women Smoking (max 5 cigarettes per day) Drug addiction, alcoholism
研究组 & 干预措施
socket seal group
After tooth extraction a soft tissue pounch is sutured above the extraction socket.
干预措施: Socket seal technique (Procedure)
XSD+ socket seal group
After tooth extraction for the reconstruction of the buccal bony wall a xenograft membrane with a long absorption rate is fixed with titanium pins to the buccal side. A soft tissue pounch is sutured above the extraction socket.
干预措施: Extraction site development technique (Procedure)
XSD+ socket seal group
After tooth extraction for the reconstruction of the buccal bony wall a xenograft membrane with a long absorption rate is fixed with titanium pins to the buccal side. A soft tissue pounch is sutured above the extraction socket.
干预措施: Socket seal technique (Procedure)
XSD+ ATB+socket seal group
After tooth extraction, the tooth will be grinded and after the sterilization procedure it will be filled back to the extraction socket. For the reconstruction of the buccal bony wall a xenograft membrane with a long absorption rate is fixed with titanium pins to the buccal side. A soft tissue pounch is sutured above the extraction socket.
干预措施: Extraction site development technique (Procedure)
XSD+ ATB+socket seal group
After tooth extraction, the tooth will be grinded and after the sterilization procedure it will be filled back to the extraction socket. For the reconstruction of the buccal bony wall a xenograft membrane with a long absorption rate is fixed with titanium pins to the buccal side. A soft tissue pounch is sutured above the extraction socket.
干预措施: autogenous tooth bone graft (Device)
XSD+ ATB+socket seal group
After tooth extraction, the tooth will be grinded and after the sterilization procedure it will be filled back to the extraction socket. For the reconstruction of the buccal bony wall a xenograft membrane with a long absorption rate is fixed with titanium pins to the buccal side. A soft tissue pounch is sutured above the extraction socket.
干预措施: Socket seal technique (Procedure)
结局指标
主要结局
Horizontal ridge width changes
时间窗: during first surgery and during 6 months reentry
The primary outcome is the alveolar ridge width change in millimeter intraoperatively, measured immediately after the tooth extraction and after 6 months at the reentry procedure (at the time of implant placement).
次要结局
- Evaluation of change of alveolar ridge volume on CBCT(at baseline and 6 months postoperatively)
- Evaluation of change of alveolar ridge height on CBCT(at baseline and 6 months postoperatively)
- Evaluation of change of alveolar ridge width on CBCT(at baseline and 6 months postoperatively)
- Examination of early wound healing phase(Pre-operative and 1, 3, 5, 7, 10, 14, 21, 28 days and 2, 3, 4, 5 and 6 months after surgeries.)
- Soft tissue volumetric changes(analysis of baseline and 6-month post-alveolar digital impressions)
- Histomorphometry(6 months postoperatively)
- Monitoring the microvascularization(Pre-operative and 1, 3, 5, 7, 10, 14, 21, 28 days and 2, 3, 4, 5 and 6 months after surgeries.)
研究者
Eleonora Solyom
PhD student
Semmelweis University