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临床试验/NCT07323433
NCT07323433招募中不适用

Efficacy of a Chitosan Dressing in Pulpotomy of Immature Permanent Teeth:Randomized Clinical Trial

Minia University1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2025年8月25日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
26
试验地点
1
主要终点
Post Operative Pain

研究概览

简要总结

Immature permanent teeth, also known as young permanent teeth, are used to describe teeth with incomplete root formation. Immature permanent teeth are prone to caries and trauma which can cause exposure and degeneration of pulp. Pulp degeneration stops root formation, leaving teeth with open apex. It is vital to preserve the pulp vitality otherwise the incompletion of root might result in the fragility of teeth. Pulpotomy is one of the most widely used methods in preserving vital pulp in teeth, which is of great significance in achieving continue root formation in immature permanent teeth suffering from dental caries or trauma. Pulpotomy is recommended by the American Association of Pediatric Dentistry for the management of pulp exposure in immature permanent teeth to achieve apexogenesis (continued root formation and closure of apex). In this procedure, coronal pulp tissue is removed in order to eliminate the infected or contaminated pulp and to reach the healthy vital pulp followed by coverage with biocompatible material.

详细描述

Immature permanent teeth, also known as young permanent teeth, are used to describe teeth with incomplete root formation. Immature permanent teeth are prone to caries and trauma which can cause exposure and degeneration of pulp. Pulp degeneration stops root formation, leaving teeth with open apex. It is vital to preserve the pulp vitality otherwise the incompletion of root might result in the fragility of teeth. Pulpotomy is one of the most widely used methods in preserving vital pulp in teeth, which is of great significance in achieving continue root formation in immature permanent teeth suffering from dental caries or trauma. Pulpotomy is recommended by the American Association of Pediatric Dentistry for the management of pulp exposure in immature permanent teeth to achieve apexogenesis (continued root formation and closure of apex). In this procedure, coronal pulp tissue is removed in order to eliminate the infected or contaminated pulp and to reach the healthy vital pulp followed by coverage with biocompatible material.

Clinically, the characteristic and the extent of pulpal hemorrhage at the exposure site are the most important outcome predictors for assessing pulpal status.

reported that excessive bleeding from the pulp revealed a significantly lower incidence of success compared with moderate bleeding. A variety of solutions and methods have been used to obtain pulpal hemostasis. Despite its limited effect on pulpal healing, sterile saline is a frequently used agent. Sodium hypochlorite (NaOCl), in concentrations of 0.5percent, achieves hemostasis without affecting pulpal repair mechanism and healing.

Hemostatic dressings have emerged as valuable adjuncts in dentistry, offering effective and efficient control of bleeding during various dental procedures. The different types of hemostatic dressings, including oxidized cellulose, gelatin- based, chitosan, and calcium-based dressings, provide localized hemostasis, reduce chair time, and improve patient outcomes.

Recently, the concept of lesion sterilization and tissue repair therapy involve the use of a mixture of antibacterial drugs for disinfection. Repair of damaged tissues can be expected if lesions are disinfected.

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
None

入排标准

年龄范围
7 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients with immature maxillary anterior teeth.
  • Patients with caries or traumatic exposed teeth .
  • Patients should be free from any systemic disease that may affect normal healing and predictable outcome class I ASA .
  • Patients who will agree to the consent and will commit to follow-up period.

排除标准

  • Patients with mature roots.
  • Patients with any systemic disease that may affect normal healing.
  • Patients with signs of periapical inflammation.
  • Patients who could/would not participate in a 1-year follow-up.
  • Teeth with periodontal involvement.
  • Teeth with vertical root fractures.
  • Non- restorable teeth.
  • cases with previously initiated endodontic treatment.

研究组 & 干预措施

Group Hemcon Dressing

Active Comparator

About 13 Participants presented with traumatic or caries exposed upper anterior teeth with immature root and they will be subjected to Application of Hemcon Dressing as A dressing material for hemostasis on pulp stump during pulpotomy of the immature teeth.

干预措施: Chitosan Dressing (Procedure)

Group of Cotton damped with normal saline

Active Comparator

About 13 Participants presented with traumatic or caries exposed upper anterior teeth with immature root and they will be subjected to Application of cotton damped with normal saline for hemostasis on pulp stump during pulpotomy of the immature teeth.

干预措施: Chitosan Dressing (Procedure)

结局指标

主要结局

Post Operative Pain

时间窗: 6 Months till 12 months

Assessment of the post operative pain via Numerical Pain Rating Scale (NRS) where the level of pain will be recorded as follows: 0 reading represents "no pain" ; 1- 3 reading represents "mild pain" ; 4- 6 reading represents "moderate pain" and 7- 10 reading represents "severe pain".

次要结局

未报告次要终点

研究者

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Salsabil Mohammed Naguib

Specialist at Health Insurance Endodontics , Minia city

Minia University

研究点 (1)

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