Treatment outcome of composite restoration performed with either indirect pulp therapy or full pulpotomy in deep proximal carious lesion- A clinical study.
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. Clinical success.
研究概览
简要总结
Dental amalgams have been the well documented, predictable, inexpensive and most widely used restorative material for over 150 years. However, they are declining in use in dentistry mainly due to their unesthetic appearance and concerns about their mercury content. The Minamata convention on mercury in 2013 has advised for the phase down of use of dental amalgam. Dental resin composites were developed to overcome the limitations of dental amalgam and response to people’s demand for an alternate tooth-coloured restoration.The current study compares the treatment outcome of composite restoration performed with either indirect pulp therapy or full pulpotomy in deep proximal carious lesion. This study is a two group parallel randomised controlled trial with a sample size of 60 patients. Preoperative clinical and radiographic assessment will be done and patients will be included based on inclusion and exclusion criterias. Block randomisation procedure / technique will be utilized to distribute subjects equally in to followings study groups
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Group I : Indirect pulp therapy (using calcium hydroxide capping)
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Group II : Full pulpotomy(using MTA as medicament)
Teeth in both the groups will receive final restoration with composite resin.
The subjects will be followed up at 6 and 12 months and teeth will be evaluated clinically and radiographically. The 12 month follow-up will be taken as endpoint for the study. Appropriate statistical test would be applied to the data generated.
So far 50 patients have been enrolled and 6 months follow up has been completed for subjects recruited in the first 6 months. One year follow up will start in 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- All
入选标准
- •Proximal carious lesion on mandibular molars.
- •Lesions with remaining dentin thickness less than 1 mm as determined on bitewing radiographs.
- •Symptoms suggestive of reversible pulpitis.
- •Positive response to cold test.
- •Teeth with restorable carious lesions.
排除标准
- •History of spontaneous sharp shooting pain suggestive of irreversible pulpitis.
- •Teeth with immature roots.
- •Teeth with sub gingival extension of proximal caries.
- •Teeth with cracks, cusp fractures, poor periodontal health.
- •Patients with systemic conditions which could compromise the healing.
- •Patients not willing to participate in the study.
- •Intra Operative Exclusion Criteria:
- •Teeth in which haemostasis cannot be achieved within 10 minutes after complete pulpotomy.
结局指标
主要结局
1. Clinical success.
时间窗: 6 and 12 months
Absence of spontaneous pain and/or sensitivity to percussion and palpation, fistula / swelling, pathological mobility. Normal probing pocket depth and positive response to pulp vitality test.
时间窗: 6 and 12 months
2. Radiographic success.
时间窗: 6 and 12 months
Absence of increase in periodontal ligament space, radiolucency at the periapical region, internal root resorption or external root resorption.
时间窗: 6 and 12 months
次要结局
- Satisfactory functional and biological parameters of posterior class II composite resin restoration as per modified USPHS criteria.(6 and 12 months)