Evaluation of Post-operative Pain After Vital Pulpotomy of Primary Molars Using Allium Sativum Oil Versus Mineral Trioxide Aggregate (MTA) : (A Pilot Study)
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- post-operative pain (spontaneous or on bitting): visual analogue scale
研究概览
简要总结
Preservation of the remaining vital portion of curiously exposed pulpal tissue in primary teeth, was one of the most frequent problems in pediatric dentistry. To solve this problem, pulpotomy therapy was introduced. Pulpotomy involves amputation of the coronal portion of affected or infected dental pulp, treatment of the remaining vital radicular pulp tissue surface should preserve the vitality and function of all or part of the remaining radicular portion of the pulp. Furthermore, it is an accepted procedure for treating both primary and permanent teeth with carious pulp exposures, several materials have been using for capping the radicular pulp after pulpotomy, these included formocresol, glutaraldehyde, ferric sulfate, and mineral trioxide aggregate.
Allium sativum is one of the most extensively researched medical plants and its antibacterial activity depends on allicin produced by the enzymatic activity of allinase (a cysteine sulfoxide lyase). Allicin and other thiosulfinates are believed to be responsible for the range of therapeutic effects reported for garlic. Garlic extract has been reported to inhibit growth of various gram-positive and gram-negative bacteria. Previous studies showed that A. sativum oil is used as new pulp medications and it offers a good healing potential, leaving the remaining pulp tissue healthy and functioning. MTA is a unique material with various advantages. It has been used successfully by pediatric dentists in a variety of clinical applications. However, its drawbacks especially its high cost, discoloration potential, difficulty in handling, and long setting time.
详细描述
- Hypothesis This research adopts null hypothesis; it assumes that the use of the both garlic oil dressed in zinc oxide powder and MTA as vital pulpotomy dressing material have the same effects.
- Trial design:
Pilot study, two arms split mouth design with 1:1 allocation ratio. Patient's, clinical and radiographic outcomes assessors and statistician will be blinded in this study. 3. Methods
Intervention
A. Diagnostic procedure:
• Clinical examination will be done on the dental clinic using mirror and probe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The statistician, clinical and radiographic outcomes assessors will be blinded in this study.
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy cooperative children with pair of contralateral deep carious mandibular primary molars indicated for vital pulpotomy.
- •In age range from 4 to 8 years.
- •Both sexes are included.
- •Patients with provoked pain.
- •Remaining radicular tissue is vital without suppuration or purulence.
- •With no clinical or radiographic signs of pulp necrosis.
- •Restorable teeth
排除标准
- •Excessive haemorrhage that cannot stop by a damp cotton pellet after several minutes
- •With congenital anomalies in teeth e.g., taurodontism, concrescence or fusion. 3- Patients who will show allergic reaction to any material will be used in this trial.
- •4- Will not be able to stick to follow up protocol in the trial and refuse to give communication data.
- •5- Patient's guardians refuse to sign up an informed consent before participating in this trial.
研究组 & 干预措施
intervention we want to test vital pulpotomy using garlic oil
interventional group as garlic oil pulpotomy dressed in zinc oxide powder
干预措施: vital pulpotomy primary molars using garlic oil (Procedure)
control or comparator as mta vital pulpotomy in primary molars
mta vital pulpotomy in primary molars
干预措施: vital pulpotomy using mta (Procedure)
结局指标
主要结局
post-operative pain (spontaneous or on bitting): visual analogue scale
时间窗: at 6 months
pain (spontaneous or on bitting) using visual analouge scale range from (0 -10) (0) No pain (10) the worst pain condition
post- operative Pain ( Spontaneous or on biting):
时间窗: 3 months
Pain ( Spontaneous or on biting) using visual analogue scale range from (0 -10) (0) No pain (10) the worst pain condition
post- operative Pain ( Spontaneous or on biting): visual analogue scale
时间窗: at 9 months
pain (spontaneous or on bitting) using visual analogue scale. range from (0 -10) (0) No pain (10) the worst pain condition
次要结局
- Pathologic internal or external root resorption(9 months)
- Swelling Clinical examination by operator. Binary (+/-)(9 months)
- Sinus or fistula Clinical examination by operator. Binary (+/-)(9 months)
- periapical radiolucency(at 9 months)
- Furcation involvement(9 months)
- Widening in the periodontal membrane space. DIGORA ® for windows software. Binary (+/-)(9 months)
- Pain on percussion Back of the mirror: visual analogue scale(9 months)
研究者
Nourhan Oma Ahmed Elgebaly
Assistnat lecturer in Pediatric Dentistry and Public Health Department Nahda University
Cairo University