Evaluation of Changes in Probing Depth Following Surgical Extraction of Mandibular Third Molars Using Particulated Autologous Tooth vs. Particulated Bovine Xenograft vs. Blood Clot: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reduction in probing depth on the distal surface of the mandibular second molar
研究概览
简要总结
This study investigates the healing of periodontal defects on the distal surface of the second lower molars after the surgical extraction of impacted third molars. Specifically, it compares the effectiveness of autologous tooth graft particles (derived from the extracted third molar) with bovine xenograft particles, using blood clot healing as a control.
详细描述
This study investigates the healing of periodontal defects on the distal surface of the second lower molars after the surgical extraction of impacted third molars. Specifically, it compares the effectiveness of autologous tooth graft particles (derived from the extracted third molar) with bovine xenograft particles, using blood clot healing as a control.
Lower third molars are the most frequently impacted teeth, and their extraction can sometimes lead to or worsen periodontal defects on the adjacent second molar. Previous studies have shown positive outcomes using various bone regeneration materials; however, autologous tooth grafts have recently emerged as a biocompatible, osteoconductive, and osteoinductive alternative with promising results. Despite this, there are no clinical studies directly comparing autologous tooth grafts and bovine xenografts in this context-justifying the present research.
A prospective, randomized split-mouth clinical trial with three arms will be conducted at the Complutense University of Madrid. Each patient will undergo bilateral lower third molar extractions under three conditions:
Group A (Test 1): socket filled with autologous tooth graft,
Group B (Test 2): socket filled with bovine xenograft,
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults (≥18 years old) of any sex, able to understand and follow study instructions.
- •Patients requiring bilateral surgical extraction of impacted lower third molars in horizontal or mesioangular position.
- •Presence of both lower second molars.
- •Classified as ASA I or ASA II (according to the American Society of Anesthesiologists).
- •Willingness to participate voluntarily and sign informed consent.
排除标准
- •Age under 18 years.
- •ASA physical status III, IV, V, or VI.
- •Pregnant or breastfeeding women.
- •Immunosuppressed patients.
- •Current treatment with NSAIDs, anticoagulants, or acetylsalicylic acid.
- •Previous or current treatment with bisphosphonates.
- •Presence of oral dysplasia or precancerous lesions.
研究组 & 干预措施
Autologous Tooth Graft (Test 1)
After surgical extraction of the impacted lower third molar, the socket will be filled with autologous tooth graft particles obtained from the extracted tooth using the Smart Dentin Grinder®. The graft particles (300-1200 µm) will be decontaminated, rinsed, and placed on the distal surface of the second molar. The graft will be covered with a resorbable hemostatic sponge (Roeko Gelatamp®) before suturing.
干预措施: Autologous Tooth Graft (Biological)
Bovine Xenograft (Test 2)
After extraction of the impacted lower third molar, the socket will be filled with particulate bovine xenograft (InterOss®) hydrated in sterile saline. The material will be placed on the distal surface of the second molar and covered with a resorbable hemostatic sponge before suturing.
干预措施: Autologous Tooth Graft (Biological)
Blood Clot (Control)
Following extraction of the impacted lower third molar, the socket will be left to heal naturally through blood clot formation, without placement of any graft material or hemostatic sponge. Standard wound closure and postoperative care will be provided.
结局指标
主要结局
Reduction in probing depth on the distal surface of the mandibular second molar
时间窗: Baseline (preoperative), 3 months, and 6 months post-extraction
Periodontal probing depth (in millimeters) measured on the distal surface of the lower second molar using a calibrated periodontal probe (CP12). The reduction in probing depth will be compared among the three groups (autologous tooth graft, bovine xenograft, and blood clot control) to evaluate periodontal healing following extraction of the lower third molars.
次要结局
- Postoperative swelling(Preoperative, 48 hours, and 7 days post-extraction)
- Postoperative trismus(Preoperative, 48 hours, and 7 days post-extraction)
- Wound healing quality(48 hours, and 7 days post-extraction)
- Patient-reported quality of life(7 days post-extraction)
研究者
Miguel Ruiz Rincón
Department of Dental Clinical Specialties, Faculty of Dentistry, Complutense University of Madrid, Madrid, Spain.
Universidad Complutense de Madrid