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临床试验/NCT05427851
NCT05427851Unknown不适用

Effect Of Diode Laser And Platelet Rich Fibrin In Regenerative Pulpotomy Of Mature Permanent Molars With Irreversible Pulpitis (A Randomized Controlled Clinical Trial)

Alexandria University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2019年4月10日最近更新:
适应症

试验速览

阶段
不适用
入组人数
36
试验地点
1
主要终点
regenerative pulpotomy success

研究概览

简要总结

Thirty six patients are included in this study. For each patient, a pulpotomy procedure is performed.

详细描述

For each patient, a pulpotomy procedure is done. Group I (n=12) pulpotomy is performed and hemostasis is achieved by applying NaOCl, then the radicular pulp is covered with Platelet Rich Fibrin (PRF) and capped with Biodentine, Group II (n=12) pulpotomy is done as in group I and hemostasis is achieved using diode laser and remaining pulp is capped with Biodentine, Group III (n=12) pulpotomy is performed and hemostasis is achieved as in group II then radicular pulp is covered with PRF then capped with Biodentine, The teeth are then restored with Glass ionomer cement followed by composite restoration. Pain is recorded every 24 hours for 7 days after intervention. Clinical and radiographic follow-up are done at 1,3,6,9 and 12 months. Cone beam computed tomography (CBCT) is done immediate postoperative and will be used for the assessment of the outcome of the pulpotomy procedure at the end of the study period.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients between 18 and 40 years of age.
  • Deep caries in a permanent lower molar with mature roots.
  • Clinical diagnosis of symptomatic irreversible pulpitis
  • No signs of pulpal necrosis including sinus tract or swelling.
  • Vital bleeding pulp tissue should be present in all canals after complete pulpotomy.
  • The tooth is restorable.

排除标准

  • Patients with systemic disease.
  • Negative response to cold testing.
  • Presence of sinus tract or swelling.
  • No pulp exposure after caries excavation.
  • Bleeding could not be controlled
  • Absence of bleeding from any of the canals.
  • Teeth with radiographic signs of internal resorption.
  • Pulpal calcifications.
  • Non-restorable teeth

结局指标

主要结局

regenerative pulpotomy success

时间窗: 12 months

Assessing the clinical and radiographic success rate of the regenerative pulpotomy. • Teeth were considered as clinical success if patients had lack of pain (spontaneous or on chewing), sinus tract or swelling, pathological mobility, and had intact coronal restoration.( procedure done in permanent mature teeth with irreversible pulpitis. Treatment was considered radiographically successful if no pathosis was evident on the recall radiograph such as root resorption, no furcal or periapical rarefaction. Periapical Index (PAI) was used to evaluate the periapical tissue condition by comparing the pre-operative radiographs with the follow-up radiographs.

次要结局

  • Postoperative pain(7 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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