Clinical and Radiographic Evaluation of Resin Endocrown as Long Term Interim Restoration Versus Stainless Steel Crown for Endodontically Treated First Permanent Molar in Children: Randomized Controlled Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Postoperative pain
研究概览
简要总结
management of endodontically treated first permanent molar with deep dental caries is one of the challenging procedure that the operator face. Using resin endocrown or stainless steel crown restoration to make comparison which one is more successful in children.
详细描述
Diagnostic procedure:
Diagnosis of the cases will be performed according to guidelines of AAPD 2017 for treatment of irreversible pulpitis and necrotic pulp therapy in mandibular first permanent molar . Preoperative periapical radiograph will be taken
Intra operative procedure:
Local anaesthesia administration using articaine 4% with epinephrine 1:100000. Rubber dam application and access cavity preparation will be established using a sterile bur. Root Canal Treatment will be done and then the dental orifices of the pulp chamber will be sealed using a flowable composite.
The immediate postoperative radiograph will be done to reveal optimal root canal treatment.
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 (Care Provider, Outcomes Assessor)
盲法说明
The statistician will be blinded throughout the whole procedures (double blind). Principle investigator will be responsible for all clinical procedures.
入排标准
- 年龄范围
- 10 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cooperative children in age range from 10 to 13 years
- •Mandibular first permanent molar indicated for root canal treatment with closed apex.
- •Presence of at least two to three sound walls of tooth.
- •Absence of internal or external pathologic root resorption.
- •Normal occlusion without any para-functional habits.
- •Parent or guardian agree for participant in the study
排除标准
- •Excessive mobility.
- •Children with underlying systemic disease.
- •Children with special health care needs.
- •Poor oral hygiene.
结局指标
主要结局
Postoperative pain
时间窗: one year
Will be recorded by using modified wong-baker pain scale (0 -3). Zero= no pain, 1= slight pain, 2=moderate pain, 3= severe pain. Principle investigator will ask the patient about the pain.
Probing pocket depth (PPD)
时间窗: one year
Periodontal probe. (1-5 mm):It will be measured in mesiobuccal, distobuccal, mesiolingual, and distolingual areas. The periodontal probe will be inserted into the gingival sulcus parallel to the longitudinal axis of the tooth and will be moved in a walking fashion.
Retention
时间窗: one year
Clinical evaluation by Principle investigator. Binary (Yes/No)
Gingival bleeding
时间窗: one year
Gingival Index(GI)Scale (0-3): score 0: normal gingiva, score1: mild inflammation, slight change in colour, slight oedema, no bleeding on probing, score2: moderate inflammation, redness, oedema, and glazing, bleeding on probing, score3: severe inflammation, marked redness and oedema, ulceration tendency to spontaneous bleeding.
Patient satisfaction
时间窗: one year
Patient and guardian satisfaction with restorative treatment was classified as (score from 1-4) 1= very dissatisfied, 2= dissatisfied, 3= satisfied and 4= very satisfied
次要结局
- Radiograph in Terms of root fracture(one year)
研究者
Basheer Ali Mabkhot
Principal Investigator
Cairo University