Comparison of Sticky Bone and Chitosan-Based Grafting for Alveolar Ridge Preservation Following Tooth Extraction
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 12
- 主要终点
- Change in Alveolar Ridge Width
研究概览
简要总结
Alveolar ridge preservation (ARP) is commonly performed following tooth extraction to minimize post-extraction dimensional changes and maintain the alveolar ridge for subsequent implant placement. This study aims to clinically compare two grafting approaches for alveolar ridge preservation: a sticky bone consisting of bone graft mixed with platelet-rich fibrin (PRF), and bone graft combined with chitosan. The study will evaluate the effectiveness of these two approaches in preserving the dimensions and quality of the alveolar ridge following tooth extraction.
详细描述
The present study is designed to clinically compare two approaches for alveolar ridge preservation following tooth extraction: a particulate bone graft combined with autologous advanced platelet-rich fibrin, forming a sticky bone graft, and the same particulate bone graft combined with chitosan. The study will use a split-mouth design, in which eligible patients requiring extraction of comparable teeth on both sides of the oral cavity will receive the two different interventions, with each side serving as a treatment site.
Following atraumatic tooth extraction and standardized socket debridement, the extraction sockets will undergo alveolar ridge preservation using one of the two assigned grafting approaches. In the PRF site, autologous PRF will be prepared from venous blood and combined with the particulate bone graft. In the chitosan site, the same type of particulate bone graft will be combined with chitosan to obtain a homogeneous grafting mixture. The graft materials will then be placed within the extraction sockets according to the standardized surgical protocol, followed by wound closure and routine postoperative care.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 65 years.
- •Systemically healthy or with mild systemic disease classified as ASA physical status I-II.
- •Clinical indication for extraction of two contralateral, symmetrical single-rooted teeth in the maxilla or mandible, with extraction not indicated because of periodontal disease.
- •Intact alveolar socket walls following extraction, including the buccal, lingual/palatal, mesial, and distal walls, confirmed clinically after extraction and supported by preoperative CBCT assessment.
- •A minimum width of 2 mm of keratinized tissue at each planned extraction site.
- •Good oral hygiene, defined as an O'Leary Plaque Control Record of less than 25%.
排除标准
- •Uncontrolled systemic diseases or conditions that may adversely affect bone metabolism or healing, including uncontrolled diabetes mellitus, hyperparathyroidism, or treatment with bisphosphonates, particularly intravenous administration.
- •Previous radiotherapy to the head and neck region.
- •Immunosuppression, including active chemotherapy or long-term treatment with high-dose systemic corticosteroids.
- •Pregnancy or breastfeeding.
- •Multirooted teeth, including molars or teeth with root furcation involvement.
- •Known allergy or hypersensitivity to bovine collagen, if a bovine-derived bone graft is used, or to chitosan or shellfish products such as shrimp.
- •Acute infection or a purulent abscess at the extraction site, or a large periapical lesion.
- •Presence of buccal bone dehiscence or fenestration at the planned extraction site.
- •Current smoking.
- •Untreated or inadequately controlled periodontal disease.
研究组 & 干预措施
Sticky Bone (PRF Combined with Bone Graft)
This arm will receive a particulate bone graft combined with autologous advanced platelet-rich fibrin, forming a cohesive sticky bone graft, for alveolar ridge preservation following tooth extraction. This intervention will be applied to one eligible extraction site in each participant.
干预措施: Sticky Bone (PRF Combined with Bone Graft) (Procedure)
Chitosan Combined with Bone Graft
This arm will receive the same particulate bone graft combined with chitosan for alveolar ridge preservation following tooth extraction. This intervention will be applied to the contralateral eligible extraction site in each participant
干预措施: Chitosan Combined with Bone Graft (Procedure)
结局指标
主要结局
Change in Alveolar Ridge Width
时间窗: Immediately after the surgical procedure (T1) and at 4 months postoperatively (T2)
The change in alveolar ridge width will be assessed by comparing cone-beam computed tomography (CBCT) measurements obtained immediately after the surgical procedure (T1) with those obtained at 4 months postoperatively (T2). The corresponding CBCT images from T1 and T2 will be spatially matched using the OnDemand 3D imaging software to ensure standardized identification and measurement of the same anatomical levels at both time points. Alveolar ridge width will be measured at three standardized levels located 3 mm, 7 mm, and 10 mm apical to the cementoenamel junction (CEJ) of the tooth indicated for extraction. For each level, the change in ridge width will be calculated as the difference between the measurement at T1 and the corresponding measurement at T2. Alveolar ridge width and its change will be recorded in millimeters (mm).
次要结局
- Change in Alveolar Ridge Height(Immediately after the alveolar ridge preservation procedure (T1) and 4 months postoperatively (T2))
- Change in Bone Graft Volume(Immediately after graft placement (T1) and 4 months postoperatively (T2))
- Change in Bone Density at the Grafted Site(Immediately after graft placement (T1) and 4 months postoperatively (T2).)
- Early Wound Healing(Postoperative days 7,14,21,30 days)
- Postoperative Complications(Postoperative days 3, 7, and 14)
- Postoperative Pain(During the first 7 postoperative days)
- Postoperative Analgesic Consumption(During the first 7 postoperative days)
- Postoperative Bleeding(During the first 7 postoperative days)
- Postoperative Edema(Postoperative days 3, 5, and 7)
- Duration of Impairment of Daily Activities(During the first 14 postoperative days)
- Patient Satisfaction with Treatment at Each Extraction Site(4 months postoperatively)
- Change in Oral Health-Related Quality of Life(Baseline and 4 months postoperatively)
- Feasibility of Dental Implant Placement(4 months postoperatively)
- Need for Additional Bone Augmentation Before Implant Placement(4 months postoperatively, before implant placement)
- Width of Keratinized Tissue(4 months postoperatively)
- Willingness to Undergo a Second Surgical Procedure(4 months postoperatively)