Adjacent Molar Outcomes After Impacted Mandibular Third Molar Surgery With PRF or Collagen Sponge: A Randomized Split-Mouth Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Fractal Dimension and Lacunarity Values for Bone Healing
研究概览
简要总结
This study aims to compare platelet-rich fibrin (PRF) and an absorbable collagen sponge in extraction sockets following impacted mandibular third molar removal in terms of postoperative clinical healing and periodontal and radiographic outcomes of adjacent second molars.
Twenty-nine systemically healthy patients with bilaterally symmetrical impacted mandibular third molars will be included, and a total of 58 extraction sockets will be analyzed. Patients will be randomized using a sealed-envelope method into either the PRF group or the absorbable collagen sponge (Surgispon) group. In this split-mouth design, one side will receive the intervention and the contralateral side will serve as a control.
Clinical and periodontal parameters will be recorded postoperatively, and radiographic healing will be evaluated using fractal analysis and lacunarity.
详细描述
This study is designed as a prospective, randomized, controlled, split-mouth clinical trial to evaluate the effects of platelet-rich fibrin (PRF) and an absorbable collagen sponge on postoperative healing following impacted mandibular third molar extraction.
Impacted mandibular third molar surgery is commonly associated with postoperative complications such as pain, swelling, trismus, and delayed healing. In addition, periodontal defects on the distal surface of the adjacent second molar and delayed bone healing in the extraction socket are clinically important concerns.
PRF is an autologous biomaterial rich in growth factors that may support tissue healing and regeneration. Absorbable collagen sponges are biocompatible materials that stabilize the blood clot and provide a scaffold for tissue regeneration. However, direct comparisons of these two materials within the same patient population are limited.
A total of 29 systemically healthy patients aged between 18 and 30 years with bilaterally symmetrical impacted mandibular third molars will be included. A split-mouth design will be used, where one side will receive the intervention and the contralateral side will serve as a control. Randomization will be performed using a sealed-envelope method.
All surgical procedures will be performed under local anesthesia using a standardized protocol. Following tooth extraction, PRF or collagen sponge will be applied to the socket according to randomization, while the control side will heal naturally. All surgical sites will be sutured using a standardized technique.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presence of bilaterally impacted mandibular third molars
- •Indication for extraction due to recurrent pericoronitis, non-restorable caries, or periodontal or orthodontic reasons
- •Age between 18 and 30 years
- •Systemically healthy individuals
排除标准
- •Presence of acute infection or pathology in the surgical region
- •Systemic or immunological disease
- •Uncontrolled diabetes mellitus
- •History of chemotherapy or radiotherapy
- •Use of anticoagulants, steroids, or medications affecting bone metabolism
- •Pregnancy
研究组 & 干预措施
Control (Spongostan group)
In this split-mouth design, no material is applied to the extraction socket on the control side following mandibular third molar removal. Standard postoperative care is provided.
Control (PRF group)
In this split-mouth design, no material is applied to the extraction socket on the control side following mandibular third molar removal. Standard postoperative care is provided
Collagen Sponge (Surgispon)
In this split-mouth design, an absorbable collagen sponge (Spongostan) is placed into the extraction socket on the allocated side following mandibular third molar removal. The contralateral side serves as an untreated control.
干预措施: Absorbable Collagen Sponge (Biological)
Platelet-Rich Fibrin (PRF)
n this split-mouth design, platelet-rich fibrin (PRF) is applied to the extraction socket of the impacted mandibular third molar on the allocated side following tooth removal. The contralateral side serves as an untreated control.
干预措施: Platelet-rich fibrin (PRF) (Biological)
结局指标
主要结局
Fractal Dimension and Lacunarity Values for Bone Healing
时间窗: 12 weeks postoperatively
Radiographic bone healing in the extraction socket will be evaluated using fractal analysis and lacunarity measurements derived from standardized radiographs.
Postoperative Pain Score (Visual Analog Scale)
时间窗: 3 days postoperatively
Postoperative pain will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where higher scores indicate greater pain.
次要结局
- Number of Participants with Alveolar Osteitis (Clinical Diagnosis)(post op 7 days)
- Facial Swelling Distance (Tragus-Commissure and Tragus-Pogonion Measurements in mm)(posoperatively 3 days)
- Mean Periodontal Probing Depth (mm) at Distal Surface of Mandibular Second Molar(post op 7 days)
- Mean Gingival Recession (mm) at Distal Surface of Mandibular Second Molar(post op 7 days)
- Gingival Index Score (Löe and Silness Index, 0-3 Scale)(post op 7 days)
- Bleeding on Probing (Presence/Absence at Distal Surface of Second Molar)(postop 7 days)