Comparative Evaluation of Success Rate of TheraCal LC Coronal Pulpotomy and MTA Coronal Pulpotomy in Cariously Exposed Mature Permanent Molars- A Randomized Clinical Study
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Clinical success rate
研究概览
简要总结
To evaluate and compare the clinical and radiographic success rate of TheraCal LC and MTA for coronal pulpotomy of mature permanent molar in 9-14 year children.
详细描述
Rationale:
Pain caused by pulpitis is one of the most common reasons for emergency dental visits. The maintenance of the vitality of the dental pulp is one of the crucial targets of modern dentistry, based on the concept of minimally invasive dentistry. Preserving the vital pulp helps in retaining proprioceptive, reparative, tooth sensitivity (innervation), vascularization, and damping functions provided by vital pulp, which help in protecting against harmful stimuli. The traditional treatment modality for permanent mature teeth with irreversible pulpitis is nonsurgical root canal treatment (NSRCT) Moreover, these treatments are lengthy and costly, and are often subject to retreatment. Many biological and clinical studies have shown that the pulp of mature teeth, which is exposed due to carious lesions, is able to be heal, and that VPT should not be limited only to young or asymptomatic teeth. Therefore, a more conservative approach of VPT has been proposed for teeth with irreversible pulpitis. A favorable outcome of this approach depends on two factors: the healing ability of the remaining vital pulp and the biocompatibility of the pulp-capping agents used. Recent studies have observed success rates ranging from 82% to 95% using modern restorative materials in mature permanent teeth, thereby suggesting that pulpotomy can be a useful alternative to RCT in adults. Hydraulic calcium silicate cements (HCSCs) are recommended as the "gold standard" material for conservative treatment of the exposed pulp. MTA is one of the most commonly used and researched material for such purposes with successful clinical outcomes. However, due to certain inherent drawbacks of MTA, such as, extended setting time and tooth discolouration there is a need for the development of newer materials to overcome the challenges associated with MTA. TheraCal LC is a material that creates a new category of resin-modified calcium silicates. It displayed significantly higher calcium-releasing ability and lower solubility than either MTA or calcium hydroxide. This high calcium release has been shown to be critical for the stimulation of apatite formation and secondary dentin bridge formation while providing a mechanical seal of the pulp. TheraCal LC doesn't discolours tooth and also have ease in handling the material with fast setting time. Hence it is been currently used in this study as pulpotomy agent to evaluate the success rate.
Aim:
To evaluate and compare the clinical and radiographic success rate of TheraCal LC and MTA for coronal pulpotomy of mature permanent molars in 9-14 year children.
Objectives :
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)
入排标准
- 年龄范围
- 9 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient should be between 9-14 years of age
- •Intermittent or spontaneous, sharp or dull, localized, diffuse, or referred pain
- •Permanent molar tooth with deep caries and subsequent pulp bleeding evident upon excavation of caries.
- •Rapid exposure to dramatic temperature changes elicited heightened and prolonged episodes of pain even after the thermal stimulus has been removed
- •Vital bleeding pulp tissue should be present in all canals after complete pulpotomy
- •Diagnosis should be irreversible pulpitis.
- •The tooth is restorable and free from advanced periodontal disease
- •Soft tissues around the tooth are normal with no swelling or sinus tract
- •Haemostasis should be achieved after complete pulpotomy
- •The patient has non-contributory medical history
排除标准
- •Teeth with immature roots
- •Non-restorable
- •Pathological mobility
- •Pus discharge through an associated sinus tract
- •Swelling of associated tissues
- •Radiographic internal or external resorption or with any periapical rarefaction
- •Necrotic pulp upon exposure.
- •Bleeding beyond 25 minutes
- •Children with severe systemic illness (mental retardation/ severe psychotic disorders), prior history of allergy and any medical condition not permitting the intervention.
- •Parents and patients unwilling for participation in the study.
研究组 & 干预措施
Theracal LC Pulpotomy
36 children with the cariously exposed mature permanent molar teeth indicated for pulpotomy and fulfilling the inclusion criteria will be taken for the study and coronal pulpotomy will be done till the level of root canal orifice.
干预措施: Theracal LC (Drug)
MTA Pulpotomy
36 children with the cariously exposed mature permanent molar teeth indicated for pulpotomy and fulfilling the inclusion criteria will be taken for the study and coronal pulpotomy will be done till the level of root canal orifice.
干预措施: MTA (Drug)
结局指标
主要结局
Clinical success rate
时间窗: Baseline to 12 months
Clinical success criteria : 1. No history of spontaneous pain or discomfort except for the first day after treatment 2. No tenderness to palpation or percussion and the tooth is functional 3. Normal mobility and probing pocket depth 4. Soft tissues around the tooth are normal with no swelling or sinus tract
Radiographic success rate
时间窗: Baseline to 12 months
Radiographic success criteria: 1. No pathosis evident on the radiograph such as root resorption, new furcal or periapical pathosis 2. No canal obliteration
次要结局
- Pain assessment(Baseline to 7 days)
- Hemostasis duration(Baseline to 12 months)