Clinical, Radiographic, Histological and Histomorphometric Analysis of Socket Preservation, Comparing Autogenous dentin graft and Xenograft following an Open Membrane Technique A Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- New bone formation - histological and histomorphometric analysis
研究概览
简要总结
A total of thirty-six patients were chosen and divided into two groups. Every patient who satisfies the requirements for inclusion will be progressively included to the experiment. Using an envelope system and a computer-generated table, each participant will be randomly assigned to receive either the TEST-I (Dentin graft) or TEST-II (DBBM-Collagen Geistlich Bio-Oss®). To assess the percentage of new bone formation by histological and histomorphometric analysis, to assess the dimensional changes of hard and soft tissues, to assess wound healing assessment using the Early Wound Healing Index (Watchel 2003) & Wound Healing Index (Landry et al., 1988), and to assess patient-centered outcomes in terms of pain and patient satisfaction, the surgical procedures for the assigned patients will be performed in the Department of Periodontology. Every patient that took part will be assesseed pain and patient satisfaction as measures of patient-centered outcomes. Prior to surgery, all study participants underwent a comprehensive diagnostic evaluation that comprised a radiograph of the afflicted area, study casts, intraoral photos, and routine blood parameter checks (FBS/PPBS, Bleeding Time (BT), Clotting Time (CT), International Normalized Ratio (INR), and platelet count). A comprehensive oral prophylaxis was then carried out. The Modified Plaque Index (Silness and Loe, 1964), the Gingival Index (Loe and Sillness, 1967), and the Modified Sulcus Bleeding Index (Mombelli et al., 1987) will be done to quantify oral hygiene at baseline for all patients prior to oral prophylaxis. Using the UNC-15 probe, the clinical width of keratinized gingiva will be assessed. The measurement of buccal bone thickness and horizontal ridge width will be based on baseline CBCT. Atraumatic tooth extraction under local anesthesia must be carried out using periotome and peizotome without opening a mucoperiosteal flap. After the socket has been completely curetted, it must be irrigated with sterile saline and examined for the presence of fenestration, dehiscence, or perforations. In the first test group, the entire socket is filled with 300–1200 μm of dentin graft. The extracted tooth will be put in the dentin crusher (KometaBio grinding device) in order to prepare the dentin graft. After being gathered and let to sit at room temperature for five minutes, the crushed dentin particles will be dehydrated using sterile gauze. In order to obtain an autogenous dentin bone graft, phosphate buffered solution (PBS) will be added to the dish containing the dentin particles in order to equalize the pH. This process will be repeated. (Size: 300–1200 μm) In test group II, all of the (DBBM-Collagen Geistlich Bio-Oss®) particles (250–1,000 μm) are entirely packed into the socket. Collagen membrane (Geistlich Bio-Gide®) is used to cover the extraction socket in both groups, and it is sutured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Age ≥ 20 years Type I extraction socket morphology Healthy or stable periodontal status Teeth that is indicated for extraction due to caries, fracture, endodontic failure Need for implant restoration at the site of extraction.
排除标准
- •Medical and general contraindications for the surgical procedure, expressed by ASA score ≥ III (Smeets, de Jong, & Abrahamâ€Inpijn, 1998) Patients with any systemic disorder known to interfere with periodontal treatment such as diabetes, coronary heart disease, Rheumatoid Arthritis, Rheumatic Fever, SLE, Malignancy, Respiratory diseases, Renal diseases, Other (e.g., autoimmune diseases, fungal infections, immunological deficiencies, etc.) Presence of periodontal disease, expressed by pocket probing depths of ≥4 mm and bleeding on probing (modified sulcus bleeding index score ≥2); Smoking Earlier treatment with radiotherapy to the head and neck region Pregnancy Post-extraction bony defect Patients on intramuscular or intravenous bisphosphonates Allergies or sensitivity to alginate, latex, collagen or acrylic.
结局指标
主要结局
New bone formation - histological and histomorphometric analysis
时间窗: Histological , Histomorphometric and Radiographic , Clinical- Baseline, 4 months | PROMs- 5 days and 1 month
Horizontal ridge width and vertical bone height - Radiographic analysis
时间窗: Histological , Histomorphometric and Radiographic , Clinical- Baseline, 4 months | PROMs- 5 days and 1 month
Width of keratinized gingiva - Clinical analysis
时间窗: Histological , Histomorphometric and Radiographic , Clinical- Baseline, 4 months | PROMs- 5 days and 1 month
PROMS - Wound healing , Pain and patient satisfaction
时间窗: Histological , Histomorphometric and Radiographic , Clinical- Baseline, 4 months | PROMs- 5 days and 1 month
次要结局
- New bone formation - histomorphometric analysis(Width of keratinized gingiva - Clinical analysis)
研究者
S Poojyashree
Sri Ramachandra Institute Of Higher Education and Reseach.
