Comparison Between Two Regenerative Scaffolds Outcome in The Treatment of Mature Teeth With Necrotic Pulp and Periapical Radiolucency
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- healing
研究概览
简要总结
This study was performed to compare endodontic regeneration outcome in necrotic mature single rooted teeth with periapical radiolucency using platelet rich fibrin (PRF) & concentrated growth factor (CGF) as a different natural scaffold by evaluation of:
- Regaining pulp sensibility by thermal test (hot and cold)
- Periapical healing using digital radiography and selected samples will be evaluated using Cone Beam Computed Tomography (CBCT).
详细描述
The current study was designed as randomized controlled clinical trial with an allocation ratio 1:1 and conducted in the clinic of Endodontic Department, Faculty of Dental Medicine for Girls, Al-Azhar University. The study was designed, analyzed and interpreted according to the Consolidated Standards of Reporting Trials (CONSORT 2010) checklist of information. Ethical approval for the human research was obtained in accordance with guidelines from Research Ethics Committee (REC) of the institute with the code number: P-EN-21-02. All patients read and signed an informed consent form with details about the study along with the benefits and risks of the therapy (Appendix A).A total of thirty-six patients were examined for this study.
After clinical and radiographic examinations only eighteen patients from cases that were fulfilling the inclusion criteria were selected according to sample size calculation. Eighteen cases was divided randomly into two groups (9 cases each):
Group I (PRF group):
Preparation of PRF:
Five ml blood was drawn from the patient's right median cubital vein into a test tube without the addition of an anticoagulant and centrifuged immediately at 3000 rpm for 10 minutes
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Eighteen papers were numbered from 1 to 18 and individually packed in opaque envelopes. Each patient picked an envelope before the beginning of the second visit. The number in the envelope determined the regenerative protocol which was to be performed for the participant. The patient was not informed of what procedure he/she was subjected to
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Agree to participate in this study and provide informed consent
- •Age range of 18 - 30 years
- •Free from systemic diseases.
- •Having necrotic single-rooted maxillary central incisor with mature root and periapical radiolucency sized up to 5mm.
- •Restorable teeth that can be isolated with rubber dam and restored with direct coronal restoration.
排除标准
- •Pregnant females.
- •Generalized chronic periodontitis.
- •Non-restorable teeth.
- •Previous root canal treatment.
- •Developmental anomalies.
- •External and / or internal root resorption.
结局指标
主要结局
healing
时间窗: 1 year
The elimination of symptoms and the evidence of periapical bony healing assessed radiographically (incidence of bone formation at the apex of root which indicate complete healing of chronic periapical abscess which assessed by periapical radiograph and cbct at 6 months \& 1 year after treatment , as it appear radiolucency in radiograph which decrease by time that indicate complete healing of abscess and reformation of bone apically
次要结局
- regaining of pulp sensibility(1 year)
研究者
Taghreed Salah
lecturer assistant
Faculty of Dental Medicine for Girls