N-Acetyl Cysteine Helps Pulp Stem Cells Differentiate During Endodontic Revascularization
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Change of Root length
研究概览
简要总结
Pulp re-vascularization/regeneration is a procedure performed to allow pulpal stem cells to survive and/or differentiate to allow immature tooth root structures to grow to full maturity. Currently, the procedure includes disinfection of the necrotic root canal space and induction of bleeding to potentiate pulpal stem cell differentiation to allow root growth on an immature root. A number of studies conducted previously demonstrate that N-acetyl cysteine (NAC) potentiates differentiation of pulpal stem/stromal cells and protects pulpal cells from apoptosis. 14-18 human subjects will be recruited forming two groups where pulp re-vascularization/regeneration procedures will be performed with or without the use of NAC treatment prior to induction of bleeding. Recall follow-up appointments will be done at 6 months and 1 year post treatment with subsequent yearly appointments until full root growth has been achieved.
详细描述
We will recruit 14-18 patients under the age of 18 by means of advertising at UCLA. Two groups will be formed, one with NAC treatment during endodontic revascularization and one without. Each patient will have an adult tooth where the following criteria are met:
- Tooth with necrotic pulp and immature apex(apices)
- Pulp space is not needed for post/core, final restoration
- Compliant patient who is willing to come for at least 2-3 treatment appointments and 2-3 follow-up recall appointments.
- Patients are not allergic to calcium hydroxide intra-canal medicament
Appropriate consent forms will be obtained by the patient and the patient's parent or legal guardian. If we recruit 18 patient, 9 patients will be under regenerative endodontic therapy/re-vascularization with NAC and 9 patients without NAC.
The following procedures will be applied to the patients.
First Appointment:
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)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria include the following:
- •Subjects will be self and parent-reported as healthy individuals with no significant medical issues.
- •Radiographic assessment will determine that root(s) have not grown to completion
- •2) Vitality tests (cold testing with Endo ice and Electric pulp testing) will determine the tooth to be necrotic 3) Palpation and percussion tests may or may not be positive 4) Probings will be within 1-5mm 5) Patient will commit to coming to 2-3 treatment appointments lasting 1-3 hours each. Thereafter, patient will commit to come for followup recall appointments 6 and 12 months following last treatment appointment.
- •6) Patient must be able to tolerate sitting in a dental chair for 1-3 hours. 7) Patient will be in the age range of 6 to 18 years
排除标准
- •Exclusion criteria include patients who cannot tolerate sitting in a dental chair due to anxiety for 1-2 hours.
研究组 & 干预措施
NAC Treatment
N-Acetyl Cysteine treatment during root canal revascularization
干预措施: N acetyl cysteine (Drug)
结局指标
主要结局
Change of Root length
时间窗: 6 months and 1 year
Change of root length in millimeters over time
次要结局
未报告次要终点
研究者
David C. Han, DDS, MS
Research Scientist and Clinical Director
University of California, Los Angeles