Short Term Clinical and Radiographic Evaluation of Nano Bioactive Glass Combined With i-PRF Scaffold in Vital Pulp Treatments in Mature Permanent Mandibular Molars: A Triple Blinded "Randomized Controlled Trial"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pain measurement (change is being assessed)
研究概览
简要总结
With consideration of the previous studies regarding the properties of i-PRF, it will be used in combination with another bioactive material: (Nano-BAG) versus using of i-PRF only as a pulpotomy material with using a premixed bioceramic putty as a coronal sealing material in both cases, to evaluate if there is a difference in the success rate of pulpotomy in case of using Nano-BAG in combination with i-PRF
So, in this study the investigators will use Nano-BAG in combination with i-PRF as a material for pulpotomy in cases of mature permanent mandibular molars and compare its outcomes with using i-PRF only and in both cases pulpotomy material will be covered with a layer of premixed bioceramic putty for coronal sealing.
详细描述
The aim of this study is to evaluate the outcome of i-PRF mixed with Nano-bioactive Glass powder and i-PRF alone covered with a layer of premixed bioceramic putty when used as a material for pulpotomy in terms of relieving pain and maintaining the radicular pulp vitality and inducing dentin bridge formation in mature permanent mandibular molars.
Research Question:
Will i-PRF mixed with Nano-BAG and covered with premixed bioceramic putty gives similar results in relieving pain , conservation of the radicular pulp vitality and dentin bridge formation compared with i-PRF alone covered with premixed bioceramic putty when using it as a material for pulpotomy in mature permanent mandibular molars?
Interventions:
A- Intervention for each group
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
- The participant will be blinded to the materials will be used during the pulpotomy process.
- The outcome assessors will be blinded.
- The operator will not be blinded for both materials during pulpotomy procedure as the two materials having different colors and different handling techniques.
入排标准
- 年龄范围
- 10 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Patients suffering from symptomatic irreversible pulpitis.
- •Tooth should give positive response to cold test
- •Heamostatis should be achieved after complete pulpotomy
- •Diagnosis is irreversible pulpitis with/without apical periodontitis
- •The tooth is restorable and free from advanced periodontal disease
- •Tooth is free from cracks or splits
- •Patients should be free from any systemic disease that may affect normal healing and predictable outcomes.
- •Patients who will agree to the consent and will commit to follow-up period.
- •Patients with mature root (closed apices)
- •Teeth with no periapical lesion, resorption or widening.
- •Soft tissues around the tooth are normal with no swelling or sinus tract
- •Mandibular posterior teeth only will be involved.
排除标准
- •• Patients with immature root apices.
- •Patients with any systemic disease that may affect normal healing.
- •Patients with periapical lesions or infections.
- •If heamostasis couldn't be achieved within 5-10 minutes
- •Pregnant females.
- •Patients who could/would not participate in a 6 months follow-up.
- •Patients with fistula or swelling
- •Patients with necrotic pulp.
- •Patients with old age.
- •Badly destructed teeth
- •Teeth that are non-restorable
- •Teeth that require post and core build up
研究组 & 干预措施
Control group
After control of bleeding in teeth allocated to the control group i-PRF is to be injected first. The i-PRF will be injected into the root canal to a level 3 mm below the cementoenamel junction (CEJ) then a layer of premixed bioceramic putty is to be added for coronal sealing.
干预措施: Pulpotomy for mature permanent mandibular molars (Procedure)
Intervention group
After control of bleeding in teeth allocated to the intervention group, i-PRF is to be mixed with Nano bioactive glass (Nano-BAG) powder to a putty consistency and injected into the root canal to a level 3 mm below the cementoenamel junction (CEJ), then a layer of premixed bioceramic putty is to be added for coronal sealing.
干预措施: Pulpotomy for mature permanent mandibular molars (Procedure)
结局指标
主要结局
Pain measurement (change is being assessed)
时间窗: After 24 hours and up to 7 days for postoperative pain evaluation using Visual Analogue Scale.
Measurement of the change in pain intensity using Visual Analogue Scale from 0 to 10 where higher scores mean higher pain intensity
次要结局
- Radiographic assesment (change is being assessed)(at 1 month , 3 months and 6 months)
- Tooth sensibility (change is being assessed)(at 1 month , 3 months and 6 months)
研究者
Peter Nabil Naguib
Principal Investigator
Cairo University