Evaluation of Revitalization Success Using i-PRF in Non-Surgical Root Canal Retreatment: A Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Change in Periapical Index (PAI) Score
研究概览
简要总结
The goal of this randomized controlled clinical trial is to determine whether regenerative endodontic treatment can improve healing outcomes in teeth with apical periodontitis following failed root canal treatment. The study includes adult patients who require non-surgical root canal retreatment due to persistent periapical lesions.
The main questions it aims to answer are:
Does regenerative endodontic treatment improve periapical healing compared with conventional non-surgical root canal retreatment? Does regenerative treatment increase long-term treatment success and tooth survival? Researchers will compare conventional non-surgical root canal retreatment with regenerative endodontic treatment using injectable platelet-rich fibrin (i-PRF) to see if the regenerative approach results in better clinical and radiographic outcomes.
Participants will:
Be randomly assigned to receive either conventional retreatment or regenerative endodontic treatment.
Undergo clinical and radiographic evaluations over a two-year follow-up period. Be assessed for pain, sensitivity, pulp vitality, hard tissue formation, and periapical healing.
详细描述
Apical periodontitis is a common consequence of failed root canal treatment and is primarily associated with persistent intraradicular infection. Although non-surgical root canal retreatment remains the standard treatment approach for failed primary endodontic therapy, reported failure rates range between 23% and 30%. Even after thorough chemomechanical preparation, complete elimination of microorganisms may not always be achieved. In addition, conventional treatment does not restore pulp vitality and may compromise the structural integrity of the remaining tooth tissue.
Regenerative endodontic procedures have emerged as a biologically based alternative aimed at promoting tissue regeneration within the root canal system. By utilizing biological scaffolds and growth factor-rich preparations, regenerative therapy may enhance healing, support revascularization, and potentially restore natural defense mechanisms of the tooth.
This study is designed as a randomized controlled clinical trial comparing conventional non-surgical root canal retreatment with regenerative endodontic treatment. The regenerative protocol incorporates injectable platelet-rich fibrin (i-PRF), an autologous blood-derived biomaterial obtained through low-speed centrifugation. i-PRF contains growth factors and bioactive components that may support angiogenesis, cell migration, and tissue repair.
Following local anesthesia and rubber dam isolation, previously obturated root canal fillings will be removed. Standardized chemomechanical preparation and irrigation protocols will be performed according to the assigned treatment group. In the regenerative group, i-PRF will be applied as a biological scaffold prior to placement of a bioceramic material to achieve coronal sealing. In the conventional retreatment group, canals will be obturated using established root canal filling techniques.
All procedures will be performed under standardized clinical conditions. Radiographic examinations will be obtained using positioning devices to ensure reproducibility and standardization of angulation. Patients will be monitored periodically over a two-year follow-up period to assess healing progression and treatment outcomes.
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 50 years.
- •Single-rooted maxillary anterior teeth with closed apices.
- •Presence of periapical lesion confirmed radiographically.
- •Previously treated root canal tooth requiring non-surgical retreatment.
- •Tooth has not previously undergone non-surgical root canal retreatment.
- •Tooth is considered restorable.
- •Patient is systemically healthy.
- •Patient is willing to participate and provides informed consent.
排除标准
- •Teeth without radiographic evidence of periapical lesion.
- •Teeth with developmental anomalies.
- •Patients with systemic diseases that may affect healing.
- •Pregnant patients.
- •Teeth presenting with internal or external root resorption.
研究组 & 干预措施
Conventional Non-Surgical Root Canal Retreatment
Participants will receive conventional non-surgical root canal retreatment.
干预措施: Non-Surgical Root Canal Retreatment (Procedure)
Regenerative Endodontic Treatment With Injectable Platelet-Rich Fibrin
Participants will receive regenerative endodontic treatment using injectable platelet-rich fibrin as a biological scaffold.
干预措施: Regenerative Endodontic Treatment (Procedure)
结局指标
主要结局
Change in Periapical Index (PAI) Score
时间窗: Baseline and up to 24 months
Periapical healing will be assessed using standardized periapical radiographs and scored according to the Periapical Index (PAI) system. Changes in lesion size and PAI scores from baseline to follow-up visits over a 24-month period will be evaluated.
次要结局
- Postoperative Pain Intensity(Baseline and up to 24 months)
- Percussion and Palpation Sensitivity(Baseline and up to 24 months)
- Pulp Vitality Response(Baseline and up to 24 months)
- Proportion of Teeth With Successful Healing (PAI ≤ 2)(Baseline and up to 24 months)
研究者
Melike Beyza Kaplanoğlu
Research Assistant
Marmara University