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临床试验/CTRI/2024/07/071398
CTRI/2024/07/071398
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Clinical and radiographic evaluation of biodentine and low level laser therapy for full pulpotomy in permanent teeth- A randomized controlled trial

Meba Merin Joy1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年8月12日最近更新:

概览

阶段
不适用
状态
已完成
发起方
Meba Merin Joy
入组人数
32
试验地点
1
主要终点
Clinical and Radiographic evaluation at 6 months interval

概览

简要总结

This study is a randomized controlled trial evaluating the clinical and radiographic symptoms in full pulpotomy with and without photobiomodulation using low level laser therapy at 3 months and 6 months interval. Following the inclusion and exclusion criteria and obtaining consent from the patients, they will be divided into two groups. in both the groups, caries will be excavated and coronal access will be made under rubber dam isolation.  Primary hemostasis is obtained using 2.5% sodium hypochlorite within 5 minutes. In Group A, 2-3mm thick layer of Biodentine (Septodont, France) is mixed and placed according to manufacturer’s instruction, followed by a layer of resin modified glass ionomer cement and permanent restoration using composite. In Group B, the root canal orifice will be exposed to Diode laser (SiroLaser Blue, Densply Sirona) of 660nm in continuous mode of application for approximately 60 seconds which will be kept at 1-2mm distance at 200 mW power. Both  the operator and the patient will be wearing protective eyewear during the laser application. The rest of the procedures are the same as Group A. Patients will be assessed for clinical symptoms after 24 hours and after 1 week. The primary outcome is the clinical and radiographic analysis which will be done at 3 months and 6 months interval. The patients will be clinically assessed for sensitivity, pain, tender on percussion, draining sinus, swelling and mobility. The radiographic changes such as periodontal ligament space widening, periapical radiolucency, furcal lesion, internal and external root resorption will be assessed. Success will be determined by the absence of symptoms. If failure is diagnose, the tooth will be endodontically treated.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 30.00 Year(s)(—)
性别
All

入选标准

  • Systemically healthy patients between 18 and 30 years of age Permanent mandibular first and second molar with mature roots Dental caries extending greater than or equal to 2/3rd of dentine or exposing the pulp on the radiograph Clinical diagnosis of irreversible pulpitis with no periapical changes in the radiograph Bleeding should be controlled in 5 minutes following pulpotomy Vital bleeding pulp tissue should be present in all canals after complete pulpotomy.

排除标准

  • Presence of sinus tract or swelling No pulp exposure after caries excavation Teeth with radiographic signs of internal resorption Pregnant and lactating mothers.

结局指标

主要结局

Clinical and Radiographic evaluation at 6 months interval

时间窗: 6 months

Clinical symptoms such as sensitivity, spontaneous pain, tenderness to percussion, draining sinus, swelling and mobility

时间窗: 6 months

Radiographic evaluation of periodontal ligament space widening, periapical radiolucency, furcal lesion, internal or external root resorption

时间窗: 6 months

次要结局

  • Clinical & Radiographic evaluation at 3 months interval(Clinical symptoms such as sensitivity, spontaneous pain, tenderness to percussion, draining sinus, swelling & mobility)
  • Clinical symptoms(Clinical symptoms such as sensitivity, spontaneous pain, tenderness to percussion, draining sinus, swelling & mobility)

研究者

发起方
Meba Merin Joy
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Meba Merin Joy

Bapuji Dental College and Hospital

研究点 (1)

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