Evaluation of Soft and Hard Tissue Healing After Impacted Mandibular Third Molar Surgery With the Use of E-PRF and H-PRF - a Randomized Controlled Clinical Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- The impact of E-PRF vs H-PRF vs Control on bone regeneration
研究概览
简要总结
This clinical trial aims to compare the effect of platelet concentrates E-PRF and H-PRF on soft and hard tissue healing in healthy individuals after lower third molar surgery. The main questions it aims to answer are:
Do E-PRF and H-PRF reduce complications after third molar surgery? Do E-PRF and H-PRF improve soft tissue healing after third molar surgery? Do E-PRF and H-PRF improve hard tissue healing after third molar surgery? Participants will be divided into 2 study groups and one control group. Third molar surgery will be performed according to standard protocol. In study groups, dentoalveolar defects will be filled with E-PRF and H-PRF which are products of centrifugation of the patient's blood without additives. Soft tissue and hard tissue healing will be compared between the groups.
详细描述
A Randomized, Three Parallel Arms Clinical Trial. The primary objective is to assess the clinical impact of E-PRF vs H-PRF vs Control on the soft tissue healing and post-op discomfort and complications after mandibular third molar surgery between the three groups during the healing period of 7 days.
The secondary objective is to compare bony healing between the three groups over three months using an Orthopantomograph (OPG) X-ray.
All subjects from the University of Sarajevo Faculty of Dentistry with Dental Clinical Center. Subjects that are coming for the removal of impacted mandibular third molars and match the inclusion criteria will be told about the research and offered the opportunity to participate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Orthodontic indication for impacted mandibular third molar surgery
- •Physical status I according to the guidelines of the American Society of Anesthesiologists (ASA)
排除标准
- •Presence of systemic disease
- •Presence of a condition that affects fibrin clot formation
- •History of radiation therapy or chemotherapy
- •Allergy to penicillin
- •Oral contraceptive usage
- •Smoking habit
- •Status of pregnancy or lactation
- •Presence of any acute local infection
- •Missing the adjacent second molar or indicated for extraction
结局指标
主要结局
The impact of E-PRF vs H-PRF vs Control on bone regeneration
时间窗: 3 months
Bone healing will be evaluated by comparing digital OPGs i.e. radiographic bone densitiy profiles in extraction sockets will be compared.
The impact of E-PRF vs H-PRF vs Control on soft tissue healing
时间窗: 7 days
Soft tissue healing evaluation will be done by modified Landry, Turnbull and Howley healing index. For each post-extraction site, the following parameters will be evaluated by dichotomic scale (0/1): tissue color, response to palpation, presence of granulation tissue, epithelialization of incision margins and suppuration.
次要结局
- The impact of E-PRF vs H-PRF vs Control on postoperative trismus(7 days)
- The impact of E-PRF vs H-PRF vs Control on periodontal pocket depth(3 months)
- The impact of E-PRF vs H-PRF vs Control on postoperative pain(7 days)
- The impact of E-PRF vs H-PRF vs Control on postoperative swelling(7 days)
研究者
Amila Haskic
Principal Investigator
University of Sarajevo