To Evaluate the Effectiveness of Mineral Trioxide Aggregate and Platelet Rich Fibrin Along With Biodentine as Pulpotomy Medicament in Patients With Pulpitis.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- EPT
研究概览
简要总结
The aim of this study was to clinically and radiographically evaluate the effectiveness of MTA, Biodentine, Platelet Rich Fibrin along with Mineral Trioxide Aggregate and Platelet Rich Fibrin along with Biodentine as pulpotomy medicament in patients with pulpitis.
详细描述
Sixty systemically healthy patients with irreversible pulpitis were enrolled in the study based on inclusion and exclusion criteria. All the enrolled patients were randomly allocated into 4 groups (15 each)
Group I: MTA GROUP: Vital Pulpotomy will be done using Mineral trioxide aggregate (MTA) as pulp capping agent. Group II: BIODENTINE GROUP: Vital Pulpotomy will be done using Biodentine as pulp capping agent. Group III: PRF + MTA GROUP: Vital Pulpotomy will be done using PRF and Mineral trioxide aggregate (MTA) as pulp capping agent. Group IV: PRF+ BIODENTINE GROUP: Vital Pulpotomy will be done using PRF and Biodentine as pulp capping agent Patients were assessed at 1 day,3 months, 6 months and 9 months postoperatively for pain, pulp sensitivity test, swelling or presence of any sinus tract. All the proposed teeth were assessed radiographically at1 day, 3 months, 6 months and 9 months postoperatively.
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
patient and statistician are masked about the treatment modality.
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with carious exposed tooth exhibiting clinical and radiographical evidence for pulpitis.
- •Deep caries extending ≥2/3 of dentin.
- •Tooth with positive response with cold testing.
- •Tooth with no mobility.
- •No signs of pulpal necrosis including sinus tract or swelling.
- •Patient approval for the treatment and follow up
排除标准
- •Any systemic disease that could influence the outcome.
- •Non-restorable tooth.
- •Teeth with periapical widening.
- •Tooth which cannot be isolated.
- •Teeth with marginal periodontitis or crestal bone loss.
- •Indication of post/ post and core restoration marginal periodontitis with attachment loss >5mm.
- •Teeth with immature root or calcified canal.
- •Teeth with internal and external resorption.
- •No pulp exposure after caries excavation.
- •Uncontrolled bleeding after access cavity preparation after several minutes N
- •No bleeding at all at the time of access opening
- •Pregnant or nursing women.
- •Individual hypersensitive or allergic to any product used in the study
研究组 & 干预措施
MTA GROUP
Vital Pulpotomy will be done using Mineral trioxide aggregate(MTA) as pulp capping agent.
干预措施: Mineral trioxide aggregate (Drug)
BIODENTINE GROUP
Vital Pulpotomy will be done using Biodentine as pulp capping agent.
干预措施: Biodentine (Drug)
PRF + MTA GROUP
Vital Pulpotomy will be done using PRF and Mineral trioxide aggregate (MTA) as pulp capping agent
干预措施: Mineral trioxide aggregate (Drug)
PRF + MTA GROUP
Vital Pulpotomy will be done using PRF and Mineral trioxide aggregate (MTA) as pulp capping agent
干预措施: Platelet rich fibrin (Biological)
PRF+ BIODENTINE GROUP
Vital Pulpotomy will be done using PRF and Biodentine as pulp capping agent.
干预措施: Biodentine (Drug)
PRF+ BIODENTINE GROUP
Vital Pulpotomy will be done using PRF and Biodentine as pulp capping agent.
干预措施: Platelet rich fibrin (Biological)
结局指标
主要结局
EPT
时间窗: change from baseline to 1day, 3 months, 6 months, 9 months
Electric pulp testing
cold test
时间窗: change from baseline to 1day, 3 months, 6 months, 9 months
cold test
次要结局
- Tender on percussion(change from baseline to 1day, 3 months, 6 months, 9 months)
- swelling(change from baseline to 1day, 3 months, 6 months, 9 months)
研究者
DR SURINDER SACHDEVA
PROFESSOR
Maharishi Markendeswar University (Deemed to be University)