The Effect of Using Different Scaffolds in Retreated Teeth on The Clinical and Radiological Success of Regenerative Endodontic Treatment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Proportion of Teeth Achieving Clinical and Radiographic Success at 12 Months
研究概览
简要总结
This clinical study aims to compare the clinical and radiographic outcomes of four different scaffolds used in regenerative endodontic treatment of previously root canal-treated permanent teeth requiring retreatment.
Participants will be randomly assigned to one of four groups based on the scaffold used: induced blood clot, injectable platelet-rich fibrin (i-PRF), advanced platelet-rich fibrin (A-PRF), or advanced platelet-rich fibrin plus (A-PRF+). All participants will receive the same root canal disinfection and restorative procedures, with the scaffold type differing between the groups.
Participants will be evaluated clinically and radiographically at 3, 6, and 12 months after treatment. The study will compare the groups in terms of the resolution of clinical signs and symptoms and changes observed on radiographic and cone-beam computed tomography images.
详细描述
This study was designed as a prospective, controlled clinical trial to compare the clinical and radiographic outcomes of four regenerative endodontic approaches applied to permanent teeth requiring single-root retreatment. The sample size was calculated using G*Power v3.1 (Heinrich Heine University, Düsseldorf, Germany) based on an effect size of 0.50, a significance level of 0.05, and a power of 0.80; a total of 60 patients, with 15 patients per group, were planned to be included in the study. The null hypothesis (H0) of this study is that there will be no difference in the clinical and radiographic success of four different regenerative approaches (apically induced blood clot, injected i-PRF, A-PRF, and A-PRF+) applied to necrotic permanent teeth requiring single-root retreatment. The necessary institutional approval and ethics committee approval have been obtained for this study. Patient participation will be voluntary; patients will be informed about the study, and informed consent forms will be obtained from those who wish to participate. Following the application of local anesthesia and a rubber dam, the relevant teeth will be disinfected with 2.5% NaOCl, and the general shape of the cavity will be formed using a sterile diamond bur with a high-speed, water-cooled air turbine. If caries is present, sterile steel burs attached to a low-speed micromotor and an angle piece will be used to remove it. Once the access cavity is complete, the root canal filling material will be removed with retreatment files without chemical agents. The working length will be determined, and mechanical preparation will be kept to a minimum. The apical opening will be enlarged to a diameter equal to the tip diameter of a #40 file. For root canal irrigation, 20 mL of 1.5% sodium hypochlorite, 20 mL of normal saline, and 10 mL of 17% EDTA will be used. After calcium hydroxide is placed in the root canal, the tooth will be sealed with a temporary filling material. Second Session (3 weeks later): If there are no symptoms, the temporary filling material and calcium hydroxide will be removed. A final irrigation will be performed with 20 mL of 17% EDTA. The volunteer patients included in the study will be divided into four groups according to the random assignment determined on the www.randomizer.org website.
Group 1: (Blood Clot Group) Bleeding will be induced by exiting the apical foramen with sterile Type K files to ensure the canal is filled with blood.
Group 2: (i-PRF Group) 10 cc of venous blood drawn from the patient's antecubital vein will be centrifuged at 700 rpm for 3 minutes. The upper yellow layer will be drawn up with a syringe and injected into the root canal.
Group 3: (A-PRF group) The 10 cc of venous blood obtained as in Group 2 will be centrifuged at 1500 rpm for 14 minutes. The upper yellow layer will be removed from the tube and applied to the root canal using sterile pluggers.
Group 4: (A-PRF+ group) The 10 cc of venous blood obtained as in Group 2 will be centrifuged at 1300 rpm for 8 minutes. The yellow layer on top will be removed from the tube and applied to the canal using sterile applicators.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 16 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 16-40 who are systemically healthy
- •Patients who have a permanent tooth with a single root canal and fully developed root that requires retreatment
- •Patients who may or may not have periapical radiolucency
排除标准
- •Patients who require antibiotic prophylaxis
- •Patients with systemic conditions such as diabetes or hematological disorders
- •Patients who have taken antibiotics, anti-inflammatory medications, and/or antidepressants within the past three weeks
- •Patients who are pregnant or suspect they may be pregnant during treatment
- •Patients with heavy plaque and tartar buildup on their teeth
- •Patients with redness and bleeding of the gums
- •Patients with severe gingivitis, generalized periodontitis, or a periodontal pocket depth of more than 3 mm
- •Patients with internal or external root resorption
- •Patients for whom complete isolation with a rubber dam cannot be achieved
- •Patients with an open, immature root apex
- •Patients with horizontal or vertical fractures
- •Patients with teeth having multiple roots or root canals
结局指标
主要结局
Proportion of Teeth Achieving Clinical and Radiographic Success at 12 Months
时间窗: 12 months after treatment
Clinical and radiographic success will be assessed as a composite binary outcome for each treated tooth at the 12-month follow-up. A tooth will be classified as successful if both clinical and radiographic success criteria are met. Clinical success will be defined as the absence of spontaneous pain, tenderness to percussion, tenderness to palpation, swelling, sinus tract, and pathological mobility. Radiographic success will be defined as reduction or complete resolution of the baseline periapical lesion without the development of a new periapical lesion. The outcome will be reported as the proportion of teeth achieving clinical and radiographic success at 12 months.
次要结局
- CBCT-Based Change in Aggregate Periapical Lesion Size From Baseline to 12 Months(From baseline to 12 months after treatment)
- CBCT-Based Change in Mean Dentinal Wall Thickness From Baseline to 12 Months(From baseline to 12 months after treatment)
- CBCT-Based Change in Root Canal Volume From Baseline to 12 Months(From baseline to 12 months after treatment)
研究者
Ali Erdemir
Professor doctor
Kırıkkale University