Clinical and Histological Effects of the Adjunctive Use of Polynucleotide and Hyaluronic Acid-based Gel in Alveolar Preservation After Tooth Extraction: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Histomorphometric results
研究概览
简要总结
Alveolar ridge resorption after tooth extraction is a physiological process that continues throughout the patient's life due to the loss of the periodontal ligament and lack of mechanical stimulation. Alveolar ridge preservation (ARP) techniques aim to minimize dimensional changes in the ridge after tooth extraction. These techniques involve grafting the socket to fill the bed and/or sealing it with a biomaterial. Currently, there is a polynucleotide and hyaluronic acid-based gel (Regenfast®) on the market that has proven useful in treating residual periodontal defects. Hyaluronic acid-based gels also appear to enhance the regenerative potential of critical bone defects in both in-vitro studies on rats and clinical studies. Therefore, this study aims to evaluate the clinical and histological effects of polynucleotide and hyaluronic acid-based gel in alveolar preservation procedures.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Due to the interventional nature of the study, the surgeon cannot be blinded. A randomization sequence will be generated, and each patient will be assigned a number. To ensure allocation concealment, the surgeon will be blinded to the group assignment of each patient until just before performing the alveolar preservation procedure. The investigator responsible for conducting the radiological measurements and the histomorphometric study will be blinded to the patient's group assignment.
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) who need the extraction of a single non-molar tooth in the mandible or maxilla.
- •ASA I or II
- •Intact post-extraction socket or with only one wall dehiscence (buccal or lingual) of no more than 50% of the socket.
- •The treatment plan must include the replacement of the tooth to be extracted by placing an implant and an implant-supported prosthesis.
排除标准
- •Mandibular incisors and molars.
- •Acute infection associated with the tooth that needs to be extracted.
- •Uncontrolled systemic disease.
- •Pregnant patient.
- •Patient under treatment with antiresorptives drugs (bisphosphonates or Receptor Activator of Nuclear Factor Kappa-B Ligand (i.e., Denosumab)) or antiangiogenics.
- •Smokers (>10 cigarettes a day).
结局指标
主要结局
Histomorphometric results
时间窗: 3 months
After 3 months of the ARP, A trephine with an internal diameter of 2.5 mm and a maximum length of 15 mm will be used to extract a bone core for histological analysis. Histological analyses will be performed on the entire sample area by calibrated and blinded examiners using open-source software (ImageJ, NIH). The areas of mineralized tissue and remaining xenograft material will be quantified based on their appearance and expressed as a percentage of the total area. The remaining area in the sample will be classified as non-mineralized tissue.
次要结局
- Visual evaluation of socket healing.(At 1 week and 12 weeks)
- Implant insertion torque(3 months)
- Need for additional bone regeneration for implant placement(3 months)
- Dimensional changes(Measurement at the day of the ARP and 3 months)
- Postoperative pain(During the first 7 postoperative days after ARP.)
- Analgesic medication consumption(During the first 7 postoperative days after ARP.)
- Oral health related quality of life(At the day of the ARP and 7 days postoperative)
研究者
Adrià Jorba García
DDS, MS
University of Barcelona