The Adjunction of Flowable Decellularized Human Placental Connective Tissue Matrix in Alveolar Ridge Preservation: A Split Mouth Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Soft tisse shrinakge at different time points of the test and control groups
研究概览
简要总结
This split-mouth pilot study evaluates the effectiveness of flowable decellularized Human Placental Connective Tissue Matrix (HPCTM) in alveolar ridge preservation following tooth extraction. Patients will receive HPCTM mixed with allograft particles in one extraction socket and allograft particles solely in the contralateral socket. The primary outcome is to assess dimensional changes in the alveolar ridge in terms of soft tissue shrinkage using a super-imposed intra-oral scans taken at baseline , day 10, 21 and 30 post-op and bone resorption rate by comparing pre-op and 4 months post-op cone beam computed tomography scans. Secondary outcomes include clinical soft tissue healing evaluation and commentary. The HPCTM used in this study is regulated by the US FDA under Section 361 of the Public Health Service Act (21 CFR Part 1271.10(a)).
详细描述
- Data collection: The data collection process of the patients was divided into two steps: pre and post Alvealoar ridge preservation.
Before the surgery, clinical photographs using a digital single-lens reflex camera (Canon 90D, 100mm macro lens, Tokyo, Japan) equipped with a light diffuser (Flashkap, USA), CBCT and intra-oral scans of each patient were collected and stored separately.
After the surgery, the patients were asked to re-visit the dental clinic at 10,21 and 30 days post-operatively for a check-up, clinical photographs and intra-oral scans. Following a period of 4 months, the patients were again recalled to perform a CBCT scan and get sufficient information about the implant placement.
Surgical intervention:
All cases were performed by the same surgeon (B.H) who followed the same surgical protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ranging between 20 and
- •Subjects having two hopeless teeth that needs extraction.
- •Teeth fitting in the same morphological category (mono,bi or multirooted).
- •Teeth belonging to different arch quadrants.
- •Presence of more than half of the socket bone housing.
- •Non-smoking patient.
排除标准
- •Presence of active periodontal diseases i.e Miller class II and above categories.
- •Presence of heavy metallic artefacts that can distort CBCT scans.
- •Bad oral hygiene and non-compliance.
- •Systemic diseases interfering with bone metabolism.
- •Pregnant or lactating women.
研究组 & 干预措施
Placenta treatment arm
Participants will receive allografts bone substitutes mixed with flowable human placental based connective tissue matrix in one extraction socket immediately following tooth extraction.
干预措施: Placental Extract (Biological)
Control arm
Participants will receive allografts bone substitutes solely in one extraction socket immediately following tooth extraction.
干预措施: Allograft (Procedure)
结局指标
主要结局
Soft tisse shrinakge at different time points of the test and control groups
时间窗: 30 days
Using a measurement software ( Medit design, Medit, Republic of Korea) the intra-oral scans (.STL files) obtained at different time points of the healing process will be super-imposed and aligned. the following region of interest will be selected: * Mesio-distally: 1,5 mm away from the concerned papilla peak. * Apically: A bucco-lingual/palatal line tangent to the visible muco-gingival line and parallel to the occlusal surface. The deviation between the different scans which corresponds the soft tissue shrinkage will be automatically calculated in millimeters as a mean value with standard deviation
Bone resorption rate in test and control groups
时间窗: 4 months
. A semi-automatic segmentation software (ITK-Snap 4.0, U.S. National Institute of Biomedical Imaging and BioEngineering, USA) was used to load and segment the pre and post CBCT scans. First, both CBCTs were oriented according to the Frankfort plane, then aligned using multiple fixe landmarks in different orientations to ensure a perfect match and an easy reproducibility. A standard region of interest was applied for all the measured sites as follow: A standard region of interest was applied for all the measured sites as follow: * Mesio-distal limit: 1.5 mm away from the mesial and distal surface of adjacent tooth. * Bucco-lingual limit: limited to the observed bone dimensions. * Apico-coronal limit: Coronally the most detectable bone peak at the mesial and distal sides; apically, 1.5 mm below the root tip. Using pixel-based scale, a specific threshold value was used to select and separate the desired structure from its surroundings of both pre and post-surgery CBCT. Following the aut
次要结局
- Clinical observation of the wound healing at control and test groups at 10, 21 and 30 days post-op(30 days)