PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth: A Clinical Trial
This clinical trial will compare platelet-rich plasma (PRP)-assisted regenerative endodontic treatment with conventional root canal treatment in mature permanent teeth with pulp necrosis and apical periodontitis.
Ten participants will be included, and each participant will contribute two eligible single-rooted, single-canal teeth. Within each participant, one tooth will receive PRP-assisted regenerative endodontic treatment and the other tooth will receive conventional root canal treatment.
The primary objective is to compare radiographic periapical healing between the two treatments at 12 months. Secondary outcomes will include postoperative pain, analgesic use, clinical signs and symptoms, pulp sensibility, treatment success, tooth survival, and adverse events. Clinical and radiographic follow-up will be performed at 6, 12, and 24 months.
研究概览
地位
详细说明
This prospective, single-center, within-patient clinical trial will evaluate platelet-rich plasma (PRP)-assisted regenerative endodontic treatment compared with conventional root canal treatment in mature permanent teeth with pulp necrosis and apical periodontitis.
Ten participants will be enrolled, and each participant will contribute two eligible mature, single-rooted, single-canal permanent teeth. Within each participant, one tooth will receive PRP-assisted regenerative endodontic treatment and the paired tooth will receive conventional root canal treatment. This paired design allows each participant to serve as his or her own control and is intended to reduce the influence of interindividual variability.
Both study teeth will undergo standardized chemomechanical preparation, irrigation, intracanal medication with calcium hydroxide, and a second treatment visit. In the PRP-assisted regenerative treatment arm, autologous PRP will be prepared from venous blood and introduced into the root canal after controlled apical stimulation. A bioceramic coronal barrier will then be placed, followed by definitive coronal restoration. In the conventional root canal treatment arm, the canal will be obturated with gutta-percha and bioceramic sealer and definitively restored.
Postoperative pain will be recorded separately for each study tooth at 6, 12, 24, and 48 hours and on days 3 through 7. Analgesic use will also be recorded.
Clinical and radiographic follow-up will be performed at 6, 12, and 24 months. The primary outcome will be radiographic periapical healing at 12 months, expressed as the percentage reduction in standardized periapical lesion area relative to baseline. Secondary outcomes will include postoperative pain trajectory, analgesic consumption, Periapical Index scores, complete radiographic healing, clinical success, cold and electric pulp sensibility responses, tooth survival, and adverse events.
Radiographic assessments will be performed using standardized periapical radiographs. Outcome assessors will be blinded to treatment allocation, and radiographic measurements will be performed by calibrated examiners.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：ipek eraslan akyüz, DDS
- 电话号码：29128 +90 352 207 6600
- 邮箱：ipekemamak@hotmail.com
学习地点
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Kayseri
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Kayseri、Kayseri、土耳其（türkiye）、38039
- Erciyes University Faculty of Dentistry
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接触：
- ipek eraslan akyüz, DDS
- 电话号码：29128 +90 352 207 6600
- 邮箱：ipekemamak@hotmail.com
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age 18-45 years.
- ASA physical status I or II.
- Two restorable mature permanent teeth suitable for paired allocation.
- Single-rooted, single-canal anatomy.
- Closed apices and completed root development.
- Diagnosis of pulp necrosis.
- Radiographic evidence of apical periodontitis.
- Periapical Index (PAI) score ≥3 for both study teeth.
- Periapical radiolucency ≥5 mm at its greatest radiographic dimension for both study teeth.
- Periodontal probing depth ≤3 mm and absence of advanced periodontal disease.
- Absence of pathological mobility.
- Adequate coronal tooth structure for definitive restoration and feasibility of rubber-dam isolation.
- Ability and willingness to complete postoperative pain records and attend 6-, 12-, and 24-month follow-up visits.
Exclusion Criteria:
- Previous root canal treatment or previous endodontic surgery in either study tooth.
- More than one root or more than one root canal.
- Open apex, developmental anomaly, internal or external root resorption, root fracture, or suspected vertical root fracture.
- Severe canal curvature or anatomy incompatible with standardized instrumentation.
- Non-restorable tooth or inability to obtain adequate isolation.
- Periodontal attachment loss or periodontal probing depth >3 mm.
- Pregnancy or breastfeeding.
- Systemic disease or medication likely to substantially alter inflammation, coagulation, pain perception, or healing.
- Use of analgesics, anti-inflammatory drugs, systemic corticosteroids, or antibiotics within the predefined preoperative period.
- Inability to comply with postoperative or long-term follow-up.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：PRP-Assisted Regenerative Endodontic Treatment
Participants will receive PRP-assisted regenerative endodontic treatment in one eligible mature necrotic tooth. After standardized chemomechanical preparation, irrigation, and intracanal medication with calcium hydroxide, autologous platelet-rich plasma will be prepared from venous blood and introduced into the root canal at the second visit after controlled apical stimulation. A Biodentine coronal barrier will then be placed, followed by definitive resin composite restoration. |
After standardized chemomechanical preparation, irrigation, and intracanal medication with calcium hydroxide, autologous platelet-rich plasma is prepared from venous blood and introduced into the root canal at the second visit after controlled apical stimulation. A Biodentine coronal barrier is placed, followed by definitive resin composite restoration. |
|
有源比较器：Conventional Root Canal Treatment
Participants will receive conventional root canal treatment in the paired eligible mature necrotic tooth. After standardized chemomechanical preparation, irrigation, and intracanal medication with calcium hydroxide, the canal will be obturated at the second visit with gutta-percha and NeoSealer Flo bioceramic sealer using the cold lateral condensation technique. The access cavity will then be definitively restored with resin composite. |
After standardized chemomechanical preparation, irrigation, and intracanal medication with calcium hydroxide, the root canal is obturated at the second visit with gutta-percha and NeoSealer Flo bioceramic sealer using the cold lateral condensation technique. The access cavity is then definitively restored with resin composite. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage Reduction in Periapical Lesion Area
大体时间：Baseline to 12 months
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Periapical lesion area will be measured on standardized digital periapical radiographs by calibrated blinded examiners using validated image-analysis software. Percentage lesion reduction will be calculated as [(baseline lesion area - 12-month lesion area) / baseline lesion area] × 100. Higher percentage values indicate greater radiographic healing. |
Baseline to 12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Postoperative Pain Intensity
大体时间：6, 12, 24, and 48 hours and days 3, 4, 5, 6, and 7 after treatment
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Postoperative pain will be recorded separately for each study tooth using a 100-mm visual analogue scale (VAS), where 0 represents no pain and 100 represents the worst imaginable pain. Participants will record tooth-specific pain scores at each predefined postoperative time point. |
6, 12, 24, and 48 hours and days 3, 4, 5, 6, and 7 after treatment
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Analgesic Consumption
大体时间：From treatment through postoperative day 7
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Analgesic use will be recorded for each study tooth during the postoperative follow-up period. Participants will record the time and number of analgesic doses taken. Ibuprofen 400 mg will be recommended when required, with paracetamol 500 mg used when ibuprofen is contraindicated. |
From treatment through postoperative day 7
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Periapical Index Score
大体时间：6, 12, and 24 months
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Periapical healing will be assessed using the Periapical Index (PAI) on standardized periapical radiographs. PAI scores will be determined by calibrated blinded examiners at each follow-up visit. |
6, 12, and 24 months
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Complete Radiographic Healing
大体时间：6, 12, and 24 months
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Complete radiographic healing will be assessed on standardized periapical radiographs by calibrated blinded examiners. Complete healing will be recorded when the periapical radiolucency has resolved and no radiographic evidence of progressive periapical disease is present. |
6, 12, and 24 months
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Clinical Success
大体时间：6, 12, and 24 months
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Clinical success will be defined as a functional tooth without spontaneous pain, tenderness to percussion or palpation, swelling, sinus tract, or evidence of progressive periapical disease. Teeth requiring nonsurgical retreatment, endodontic surgery, extraction, or another intervention because of persistent endodontic disease will be classified as failures. |
6, 12, and 24 months
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Pulp Sensibility Response
大体时间：6, 12, and 24 months
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Pulp sensibility will be assessed using cold testing and electric pulp testing at follow-up visits. A positive response to either sensibility test will be recorded for each study tooth. |
6, 12, and 24 months
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合作者和调查者
调查人员
- 首席研究员：ipek eraslan akyüz, DDS、TC Erciyes University
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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