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临床试验/NCT06711081
NCT06711081招募中不适用

Clinical and Radiographic Evaluation Following Complete Pulpotomy Using Low Level LASER Therapy and Cryotherapy

Tanta University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
radiographic changes

研究概览

简要总结

This in-vivo study aims to evaluate the efficacy of the low level laser therapy and cryotherapy in treatment of vital pulpotomy in mature permanent molar evaluating the post operative pain and the radiographic changes in pulpal and periodontal regions.

详细描述

Recently, there is a new direction of vital pulp therapy (VPT) that aims to preserve the tooth vitality and the root dentin and improves the long term prognosis of the tooth function. VPT is a personalized method of treating irreversible pulpitis which conforms to the trend of minimally invasive endodontics. There are many modalities of VPT like direct pulp capping, indirect pulp capping, pulpotomy and revascularization. Pulpotomy is defined as clinical procedure of removal of the coronal pulp tissue leaving the vital radicular pulp tissue as in cases of pulp exposure due to caries, trauma or iatrogenic error. Pulpotomy may be complete or partial according to the degree of extension of pulpal inflammation.

VPT depends on the theory that the pulp has the capacity of self-healing when it is free from infection. In addition, recent innovations of dental materials and techniques have been administrated to the field of endodontics have ensured higher success rate of VPT. Pulpotomy procedure has been introduced as an alternative to traditional root canal treatment in case of mature permanent teeth exhibiting symptoms of irreversible pulpitis when the radicular pulp is still vital.

There are many materials and techniques used for pulpotomy where the selection of the material used for this technique greatly influences its success rate. An ideal material for VPT must be biocompatible, antibacterial, providing biological and bacterial tight seal and promoting the regeneration of dentine-pulp complex. Calcium hydroxide (Ca(OH)2) and mineral trioxide aggregate (MTA) are considered the most commonly used materials for pulpotomy. However, Ca(OH)2 has many drawbacks as degradation over time, formation of tunnel defects beneath dentinal bridges and poor sealing ability, so it has lost its popularity as a first choice agent for pulpotomy. On the other hand, MTA has better sealing ability, biocompatibility and strength. However, it has some drawbacks like difficult handling, long setting time and discoloration of the tooth.

More recent pulpotomy materials have been introduced as putty bioceramic materials including: calcium silicate, monobasic calcium phosphate, zirconium oxide, tantalum oxide, and filler agents. They show better handling due to its premixed putty consistency in addition to its low level of tooth discoloration and rapid setting time compared to MTA.

In addition to the new materials, there are modifications of pulpotomy techniques which has been administrated to enhance its outcome as light amplification of estimated emission of radiation (LASER) and cryotherapy. The application of laser may enhance the outcomes of pulpotomy due to its ability to vaporize water in dental hard tissue so dentinal tubules will be opened and smear layer will be removed which in turn will increase the sealing ability of pulpotomy material.

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, Care Provider)

入排标准

年龄范围
15 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •• Restorable vital and mature mandibular molar teeth with irreversible pulpitis.
  • •Teeth with deep caries or large restoration.
  • •Pre-operative radiograph showing normal periapical structure.
  • •Teeth with normal periodontal status .

排除标准

  • •• Medically compromised patients with active systemic disease as uncontrolled diabetes mellitus, hypertension or cardiac diseases.
  • •Teeth with periapical lesion.
  • •Sinus tract or swelling.
  • •Moderate or severe marginal periodontitis.
  • •Patient allergic to any material or medication used in this study.
  • •Teeth with moderate to severe mobility.
  • •Teeth with periodontal diseases.
  • •Teeth with anatomical variations.

研究组 & 干预措施

• Group I: Conventional complete Pulpotomy using MTA (control group).

No Intervention

MTA putty material will be placed using premixed capsule which will be triturated according to manufacturer's instructions. MTA will be placed in a 2-3 mm layer above the pulp tissue using an amalgam carrier and gently packed to the canal orifice using a condenser, then it will be covered by moistened cotton pellet for 2 minutes to achieve the initial setting, then the cotton pellet will be removed. A layer of resin modified glass ionomer cement will be placed and the tooth will be restored using light cured composite filling material .

• Group II: LLLT following complete pulpotomy.

Active Comparator

after achieving homeostasis, LLLT will be applied using diode laser of 810 nm wave length with energy of 2 J/cm2 under a continuous mode with power output of 100 mW for about 10 sec with laser tip size 600 μm and 2 mm away from the canal orifice, Then MTA will be placed and the tooth will be restored as in group I.

干预措施: low level laser device cryotherapy (Device)

• Group III: Cryotherapy following complete pulpotomy.

Active Comparator

after achievement of homeostasis, the cryotherapy will be applied using small piece of shaved sterile ice wrapped with sterile piece of gauze (0° Celsius) which will be placed over the pulpal tissue in the pulp chamber. After approximately 60 seconds, the molten ice will be removed, then MTA will be placed and the tooth will be restored as in group I.

干预措施: low level laser device cryotherapy (Device)

结局指标

主要结局

radiographic changes

时间窗: one year after treatment

and x-ray change either pulpal or periapical using CBCT subtraction

次要结局

  • Post operative pain(one week after treatment)

研究者

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

mohamed motiea mohamed morsy

principle investigator

Tanta University

研究点 (1)

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