Quantification of active MMP9 and comparative evaluation of Biodentine with and without Human Amniotic Membrane as pulpotomy agents in mature permanent molars with symptomatic irreversible pulpitis A randomized controlled trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Patients will be asked to record their pain on a 100mm long visual analogue scale, with 0 representing no pain and 100 representing pain as bad as it could be.
研究概览
简要总结
Patients will be evaluated for inclusion criteria in the study, 36 teeth meeting the inclusion criteria will be included. Patients will be informed of the details of the treatment, and informed consent will be obtained.
A clinical diagnosis consistent with Symptomatic Irreversible Pulpitis will be established in all cases based on a history of severe spontaneous lingering pain that could be reproduced by cold testing. After clinical and radiographic examination, the tooth will be anesthetized and, isolated using a dental dam. The cavity will be prepared using a sterile high-speed diamond bur under water coolant. The exposed pulpal tissue will be amputated up to the orifice. The pulpal blood sample will be collected in a test tube using a micro pipette. The bleeding will be controlled by placing a cotton pellet soaked with NaOCl over the pulpal wound for 2 minutes and repeated for a maximum of 10 minutes. Root canal therapy will be initiated in cases in which hemostasis cannot be achieved.
Once hemostasis is confirmed, the tooth will randomly be allocated to 1 of 2 parallel arms using a predetermined computer-generated randomization. The patients will receive the allocated intervention Group 1 Biodentine or Group 2 Human amniotic membrane and Biodentine. The tooth will be sealed with light cured GIC and will be permanently restored with resin composite and a post operative periapical will be taken. The patients will have clinical and radiographic evaluation after 1, 3, 6 and 12 months.
MMP9 values will be quantified in the pulpal blood sample collected during the pulpotomy with a fluorometric assay kit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 13.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinical diagnosis of SIP without/with periapical rarefaction.
- •(PAI score 1 to 3) The tooth should give positive response to cold testing.
- •The tooth is restorable, probing pocket depth and mobility are within normal limits.
- •No signs of pulpal necrosis including sinus tract or swelling.
- •Mobility within normal limits.
- •Radiographically, no evidence of pathological root resorption, and periapical or furcal radiolucency.
排除标准
- •Teeth with immature roots Non restorable teeth Negative response to cold testing, the presence of sinus tract or swelling No pulp exposure after caries excavation Bleeding could not be controlled after full pulpotomy in 10 minutes Insufficient bleeding after pulp exposure, the pulp is judged necrotic or partially necrotic Systemic diseases like haemophilia, Von Willebrand disease, platelet abnormalities, and diabetes were excluded.
结局指标
主要结局
Patients will be asked to record their pain on a 100mm long visual analogue scale, with 0 representing no pain and 100 representing pain as bad as it could be.
时间窗: 24 and 48 hours
An investigator blinded to the study group instructed all the participants.
时间窗: 24 and 48 hours
次要结局
- Clinically, teeth will be evaluated for presence or absence of signs and symptoms associated with any pulpal or periapical disease (spontaneous or persistent pain, discomfort, tenderness on palpation or percussion, sinus, swelling of surrounding tissue), cold and electric pulp testing, periodontal status and the integrity of the restoration.
研究者
Dr Twyla Ferrao
Goa Dental College and Hospital