Comparative Clinical and Radiographic evaluation of PRF, PRF with Gelfoam and PRF with Chitosan in Mandibular Third Molar extraction socket healing - A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 144
- 试验地点
- 1
研究概览
简要总结
This study is a prospective randomized controlled clinical trial designed to evaluate and compare the effectiveness of platelet rich fibrin alone, platelet rich fibrin combined with gelfoam, platelet rich fibrin combined with chitosan, and natural healing in mandibular third molar extraction socket healing. The study will be conducted in patients requiring surgical extraction of mandibular third molars attending the outpatient department of oral and maxillofacial surgery. Eligible participants aged 18 to 40 years with good general health will be recruited based on predefined inclusion and exclusion criteria and randomly allocated into four groups, PRF alone, PRF with gelfoam, PRF with chitosan, and control where no adjunct is used. The study will follow a standardized surgical extraction protocol and PRF preparation protocol, and it will be single blinded with assessor blinding, as patient and operator blinding are not feasible due to the visible nature of the materials and ethical considerations. Follow up assessments will be conducted at 30 minutes and 60 minutes post extraction, Day 1, Day 3, Day 7, Day 14, 1 month, and 3 months after surgery.
The primary objective is to evaluate soft tissue healing and bone regeneration of extraction sockets among the four groups using clinical examination and radiographic assessment with intraoral periapical radiographs and grid analysis. Outcome parameters include soft tissue healing assessed using modified Landry healing index, bone regeneration assessed using radiographic measurements of alveolar bone height and anteroposterior socket width, hemostasis assessed by time to cessation of bleeding and modified bleeding severity scale, postoperative pain assessed using visual analogue scale, facial swelling assessed using standardized linear measurements between anatomical landmarks, trismus assessed by maximum inter incisal distance, and incidence of dry socket assessed clinically using standard diagnostic criteria. Data will be analyzed using appropriate statistical tests for intergroup and intragroup comparisons to determine whether addition of gelfoam or chitosan enhances the clinical and regenerative efficacy of platelet rich fibrin compared with PRF alone and natural healing, and to generate evidence based guidance for socket management following mandibular third molar extraction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients aged 18- 40 years.
- •Patients with good general health (ASA I).
- •Patients requiring surgical extraction of mandibular third molars.
- •(impacted, carious or, periodontally involved lower third molars indicating need for extraction)
- •Patients with adequate mouth opening to permit standard surgical access.
- •Patients willing to participate.
- •Patients willing to provide written informed consent.
- •Patients willing to comply with the study protocol and follow-up visits.
排除标准
- •Patients with systemic conditions affecting wound healing (uncontrolled diabetes mellitus, immunocompromised states).
- •Patients with bleeding disorders or platelet abnormalities.
- •Patients on anticoagulant or long-term steroid therapy.
- •Smokers, alcoholics and tobacco users.
- •Pregnant or lactating women.
- •Patients allergic to local anesthetic agents.
- •Patients with previous surgery or pathology in the mandibular third molar region.
- •Mentally challenged patients or patients who are unable to communicate.
- •Patients unwilling to participate or unable to comply with follow-up visits.
研究者
Dr Akshaya Chavan
Nair Hospital Dental College
