Effect of Different Liners on Pulpal Outcome and Survival of Composite Restorations After Partial Caries Removal: A Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 198
- 主要终点
- Evaluate and compare the clinical and radiographic success with different liners after partial caries excavation
研究概览
简要总结
Aim of the study was to determine the effectiveness of cavity liners regarding survival of restoration beneath composite restoration after partial caries removal in permanent teeth with deep caries and to evaluate and compare the pulp vitality outcome both clinically and radiologically with and without liners.
Study was conducted in Post Graduate Institute of Dental Sciences, Rohtak in department of Conservative Dentistry & Endodontics. Mature permanent mandibular molars with deep dentinal caries and without any signs of irreversible pulpitis were included in the study. After partial excavation of caries, patients were randomly allocated into three groups- RMGIC, CH and DIRECT COMPOSITE group and were restored according to standard protocol.
详细描述
AIM AND OBJECTIVES The present study aims to
- Evaluate the success of partial caries excavation in mandibular molar teeth.
- Evaluate and compare the clinical and radiographic success with RMGIC, calcium hydroxide and without liners after partial caries excavation.
- Evaluate and compare the effect of liners on restoration survival after partial caries excavation.
MATERIALS AND METHODS Study subjects were recruited from OPD of Department of conservative dentistry and endodontics, PGIDS, Rohtak.
METHODOLOGY Prior to treatment, a thorough clinical and radiological examination was carried out and a thorough history was taken.
Clinical procedure:
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
double
入排标准
- 年龄范围
- 14 Years 至 54 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient willing to participate in the study.
- •Mature permanent mandibular molars with deep dentinal caries involving more than half or two thirds of dentin.
排除标准
- •Primary teeth.
- •Teeth with irreversible pulpitis (spontaneous pain) or pulp necrosis, chronic periodontitis, cracked tooth, internal or external resorption, calcified canals, associated with sinus tract, and furcation or apical radiolucency.
- •Immuno-compromised, diabetic, pregnant and hypertensive patients.
- •Positive history of antibiotic and analgesic use.
研究组 & 干预措施
PCR WITH CALCIUM HYDROXIDE
PCR WITH CALCIUM HYDROXIDE : A layer of dycal (dentsply) was placed adjacent to pulpal or axial wall after mixing as per manufacturer recommendations followed by etching and restoration with composite using incremental technique.
干预措施: PCR with calcium hydroxide (Procedure)
PCR WITH RMGIC
PCR WITH RMGIC: A layer of resin modified liner ( GC Fuji II ) was placed adjacent to pulpal or axial wall and light cured for 40 sec. afterwards the cavity was restored with composite as in other groups.
干预措施: PCR with RMGIC (Procedure)
PCR WITH DIRECT COMPOSITE
PCR WITH DIRECT COMPOSITE: After partial caries excavation , etching and bonding was done directly without using any liner and cavity was restored with composite as in other groups
干预措施: PCR with direct composite (Procedure)
结局指标
主要结局
Evaluate and compare the clinical and radiographic success with different liners after partial caries excavation
时间窗: The patients were recalled periodically at 1 month, 3months, 6 months and 12 months after the procedure.
CRITERIA FOR SUCCESSFUL OUTCOME The Presence of positive response to vitality tests, absence of tenderness or spontaneous pain will be considered as clinical signs of success while absence of any radiolucency in periapical or furcation region or root resorptions as radiographic signs of successful outcome. CRITERIA FOR FAILURE The presence of negative vitality tests, spontaneous pain, fistula, swelling, mobility will be considered as clinical signs of failure while presence of any radiolucency in furcation or periapical region, internal or external root resorption as radiographic signs of failure. Although the procedure of partial caries excavation will be considered fully successful only when it shows successful outcome both from maintaining pulpal vitality as per primary outcome measures and intact restoration as per secondary outcome measures described below.
次要结局
- Evaluate and compare the effect of different liners on survival of composite restorations after partial caries excavation.(The patients were recalled periodically at 1 month, 3months, 6 months and 12 months after the procedure.)
研究者
Sanjay Tewari
Principal
Postgraduate Institute of Dental Sciences Rohtak