Assessment of Vital Pulp Therapy Outcome Versus Root Canal Treatment in Management of Mature Permanent Molars with Irreversible Pulpitis and Apical Periodontitis(A Randomized Double-Blinded Clinical Trial)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Postoperative pain
研究概览
简要总结
Pulpitis is the pulpal inflammation in response to irritants which are either microbial, chemical, or physical (mechanical and thermal) in origin. Clinically, pulpitis is termed as reversible or irreversible, whereas histologically, it is described as acute, chronic or hyperplastic . Pulpitis is considered reversible when the pulp can heal following conservative management . For such cases, a coronal pulpotomy is considered as a definitive treatment option having 78% to 90% of success rate . In irreversible pulpitis (IP), the pulp is not capable of healing, thus it is treated traditionally complete pulpectomy.
详细描述
I- Intervention
- Diagnosis to reach definitive diagnosis of SIP (positive response to pulp sensibility test) associated with SAP (PAI score ≤ 3), a detailed history and clinical examination should be collaborated with the radiographic evidence (CBCT) of apical periodontitis.
- Endodontic procedures
- Anesthetic protocol:
Tooth will be anaesthetized using 3.6 ml of 2% lidocaine with 1:100,000 epinephrine.
Inferior alveolar nerve block (IANB) supplemented by buccal infiltration will be accomplished using a standard aspirating syringe and a 27-G, long needle (C-K ject, CK Dental, Korea).
Access cavity preparation:
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
- Double (Participant, Outcomes Assessor)
盲法说明
Computer will be used to generate a sequence of random numbers for the allocation of participants into the groups. Once the computer-generated randomization number will be obtained, it will be sealed in an opaque envelope by one of the investigators. After the clinical and radiographic findings, the envelope will be opened by a clinical assistant and treatment will be allocated to the patient based on the sequence generated. The patients will be blinded about the procedure, and a single operator will perform all the endodontic procedures after the informed written consent.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy patients (Category: American society of anesthesiologists class I) of either gender aged from 18-40 years.
- •Permanent mature mandibular first molars with a definitive clinical diagnosis of SIP (positive response to pulp sensibility test) with SAP (PAI score ≤ 3)
排除标准
- •Patients with systemic diseases such as (diabetes, hypertension, etc.…).
- •Immunocompromised patients.
- •Pregnant women and smokers.
- •Patients with a history of antibiotic or analgesics intake within the few days before the intervention and cases with previously initiated endodontic treatment.
- •Intraoperatively, where the haemostasis (application of 2.5% sodium hypochlorite pressure pack) could not be achieved within 10 minutes.
研究组 & 干预措施
NSRCT Group
Non-surgical root canal therapy
干预措施: root canal tretment (Procedure)
VPT Group
vital pulp therapy
干预措施: biodentin VPT (Procedure)
VPT+PRF Group
vital pulp therapy with PRF
干预措施: PRF (Procedure)
结局指标
主要结局
Postoperative pain
时间窗: at 24, 48 and 72-hours
Preoperative and postoperative pain will be recorded on a point numeric rating scale by another operator. The numerical scale of pain is most commonly from 0 to 10, with 0 being "no pain" the lowest value and 10 being "the worst pain imaginable refer to the highest value, the lowest value means better outcome results.
Radiographic evaluation
时间窗: at baseline ,6 and 12-months
CBCT will be taken postoperatively to assess the periapical healing based on periapical index ( PAI) score. PAI score is ordinal scale of 5 scores ranging from 1 (healthy) lowest value to 5 (severe periodontitis with exacerbating features) highest value . The lowest value means better outcome.
次要结局
未报告次要终点
研究者
Ahmed Mohamed Abdelaal Mohamed
Assistant lecturer of Endodontics, Aswan University
Minia University