Comparison of Regenerative Endodontic Procedures Using Periapical Bleeding Induction, L-PRF, and I-PRF in Mature Teeth With Periapical Lesions: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change in Pain Level at 24 Hours, 72 Hours, and 1 Week Post-Treatment
研究概览
简要总结
This study investigates a biological approach that allows infected and necrotic teeth to heal themselves instead of being treated with traditional root canal therapy. Traditional root canal treatment involves cleaning the infected tissue inside the tooth and sealing it with a filling material, whereas regenerative endodontic treatment is a novel approach that enables the tooth to repair itself. This treatment method involves inducing bleeding in the root area or applying special blood derivatives (PRF types) to accumulate healing-supporting cells and growth factors. The aim of the study is to compare the effects of different biological treatment methods on the healing process, postoperative pain, and tooth discoloration. The results may help develop more effective and aesthetically successful treatment options in the future.
详细描述
This study investigates the effectiveness of regenerative endodontic procedures in the treatment of necrotic and infected teeth. Traditional root canal treatment involves the complete removal of infected tissue from inside the tooth and sealing the root canal with a biocompatible filling material. However, this method does not restore the tooth's natural vitality or protective mechanisms. Additionally, it may increase tooth fragility and lead to discoloration over time.
Regenerative endodontic treatment is a biological approach that promotes the self-healing of the tooth. This method applies tissue engineering principles to stimulate the formation of new tissue within the root canal. During the treatment process, either bleeding is induced at the root tip or special platelet-rich fibrin (PRF) derivatives are applied to facilitate the accumulation of stem cells, growth factors, and immune-boosting components that support healing.
This study compares the effects of different regenerative treatment methods (bleeding induction, L-PRF, and I-PRF applications) on lesion healing, postoperative pain, and tooth discoloration. By determining the most effective method for teeth with completed root development and apical lesions, the study aims to establish an optimal treatment protocol for clinical practice. The findings will contribute to the development of treatment options that preserve the natural structure of the tooth, enhance aesthetics, and improve patient comfort and long-term treatment success.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Single-rooted teeth with mature teeth with necrotic pulp requiring endodontic treatment, and a periapical lesion (Periapical Index Score (PAI) ≥3).
- •Individuals without systemic diseases, not using antibiotics, corticosteroids, antidiabetic, or antihypertensive medications, and not pregnant.
- •Patients without acute pain.
- •Patients without extraoral swelling, sinus tract, or acute apical abscess.
- •Individuals willing to participate and able to attend follow-up sessions regularly.
排除标准
- •Teeth with internal or external root resorption or vertical root fractures.
- •Immature teeth.
- •Individuals outside the age range of 14-65 years.
- •Patients with complicated systemic diseases or those using antibiotics, corticosteroids, antidiabetic, or antihypertensive medications.
- •Patients with acute pain, those who have taken analgesic medication in the last 24 hours, or those who have used antibiotics within two weeks before treatment.
- •Patients who are unlikely to attend follow-up sessions.
研究组 & 干预措施
AP
Necrotic pulped, mature teeth with apical periodontitis.
干预措施: RVS (Procedure)
AP
Necrotic pulped, mature teeth with apical periodontitis.
干预措施: L-PRF (Procedure)
AP
Necrotic pulped, mature teeth with apical periodontitis.
干预措施: i-PRF (Procedure)
结局指标
主要结局
Change in Pain Level at 24 Hours, 72 Hours, and 1 Week Post-Treatment
时间窗: Post-Treatment at 24 Hours, 72 Hours, and 1 Week
Pain levels will be assessed using the Numerical Rating Scale (NRS), ranging from 0 (no pain) to 100 (worst pain), measured at 24 hours, 72 hours, and 1 week post-procedure.
Radiographic Assessment of Lesion Healing at 6 Months
时间窗: Baseline and 6 months
Lesion healing will be evaluated using periapical radiographs with the parallel technique, and the Periapical Index (PAI) will be used for the assessment of lesion healing.
Assessment of Tooth Discoloration at 6 Months
时间窗: Baseline and 6 months
Tooth discoloration will be evaluated using a spectrophotometer based on the CIELab system, and teeth with a ΔE value greater than 3 will be considered discolored.
次要结局
未报告次要终点