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临床试验/NCT07761962
NCT07761962进行中(未招募)不适用

Comparative Evaluation of Diode Laser-Assisted Pulpotomy Versus MTA Pulpotomy in Permanent Teeth With Irreversible Pulpitis: A Randomized Clinical Trial

King Abdullah University Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年10月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
70
试验地点
1
主要终点
Postoperative pain after pulpotomy

研究概览

简要总结

This study compares two methods used during full pulpotomy, a treatment for teeth with deep tooth decay that has exposed the dental pulp.

In the first method, the dentist removes the affected pulp tissue using a high-speed dental bur and then controls the bleeding using a sodium hypochlorite solution.

In the second method, the dentist also removes the affected pulp tissue using a high-speed dental bur, but a diode laser is used to control the bleeding. The laser may provide additional disinfection and achieve bleeding control more quickly.

After treatment, participants will be monitored to assess their level of pain relief. They will also return for follow-up visits at 6 months and 12 months, when dental X-rays will be taken to evaluate the success of the treatment.

详细描述

Vital pulp therapy (VPT) is a minimally invasive treatment that aims to preserve the vitality and function of the dental pulp after exposure caused by deep caries. Compared with root canal treatment, VPT preserves the remaining healthy pulp tissue, allowing the tooth to maintain its natural defense mechanisms and reparative capacity. Full pulpotomy has become an accepted treatment option for permanent teeth with carious pulp exposure when the radicular pulp is considered healthy and capable of healing. Clinical studies have demonstrated high success rates for full pulpotomy in appropriately selected cases.

Successful pulpotomy depends on adequate removal of the inflamed coronal pulp tissue, effective control of pulpal bleeding, reduction of bacterial contamination, and placement of a suitable biocompatible pulp-capping material. Conventionally, hemostasis is achieved using sodium hypochlorite following removal of the coronal pulp tissue with a high-speed bur. Although this technique has demonstrated favorable outcomes, alternative methods that may improve hemostasis and enhance tissue healing continue to be investigated.

Diode lasers have been increasingly used in dentistry for soft tissue procedures because of their ability to provide precise tissue interaction, coagulation, and effective hemostasis. In addition to controlling bleeding, diode lasers have antimicrobial properties and may promote wound healing through biostimulatory effects that support tissue repair and reparative dentin formation. These characteristics suggest that diode laser-assisted pulpotomy may offer clinical advantages over the conventional technique.

Despite the increasing use of diode lasers in dentistry, clinical evidence regarding their use in full pulpotomy of permanent teeth with carious pulp exposure remains limited. Most published studies have evaluated diode laser pulpotomy in primary teeth or animal models, and randomized clinical trials in permanent teeth are lacking.

This randomized clinical trial is designed to compare diode laser-assisted full pulpotomy with the conventional full pulpotomy technique in permanent teeth with carious pulp exposure. In both study groups, the coronal pulp tissue will be removed using a conventional high-speed bur. In the control group, hemostasis will be achieved using sodium hypochlorite. In the experimental group, a diode laser will be used to achieve hemostasis following pulp removal. The same pulp-capping material and definitive restoration protocol will be used in both groups to ensure that the method of achieving hemostasis is the primary variable under investigation.

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
10 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •• Non -contributory medical history (SAI, II).
  • •Premolar or Molar permanent tooth
  • •Age range 10-60 years
  • •Deep caries extending>= 2/3 of dentin or exposing the pulp on the radiograph
  • •The tooth should give positive response to cold sensibility testing
  • •Clinical diagnosis of irreversible pulpitis based on the symptoms and results of cold testing.
  • •The tooth is restorable, probing pocket depth and mobility are within normal limits
  • •No signs of pulpal necrosis including sinus tract or swelling

排除标准

  • •Medically compromised patient.
  • •Non-restorable tooth.
  • •Signs of pulpal necrosis including sinus tract or swelling.
  • •No enough bleeding after the pulpotomy procedure.
  • •Inability to achieve hemostasis within 10 min after the pulpotomy.

研究组 & 干预措施

Full pulpotomy using diode laser for hemostasis

Experimental

Diode laser used after the full pulpotomy to achieve hemostasis following cutting of the pulp tissue.

干预措施: Diode laser full pulpotomy (Procedure)

Full pulpotomy using sodium hypochlorite for hemostasis

Active Comparator

The use of sodium hypochlorite to achieve hemostasis after cutting the pulp tissue to th level of root canal orifices

干预措施: Sodium hypochlorite pulpotomy (Procedure)

结局指标

主要结局

Postoperative pain after pulpotomy

时间窗: One week after treatment

Postoperative pain will be assessed using an 11-point Numeric Rating Scale (NRS), where 0 indicates "no pain" and 10 indicates "the worst pain imaginable." Participants will record their pain intensity at the prespecified postoperative time points.

次要结局

  • Success of pulpotomy(Six and 12 months after treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nessrin Taha

Professsor

Jordan University of Science and Technology

研究点 (1)

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