跳至主要内容
临床试验/NCT07336498
NCT07336498进行中(未招募)不适用

Clinical Evaluation and Cone Beam Computed Tomography Analysis of Amniotic Membrane, Putty Mineral Trioxide Aggregate and Biodentine as Therapeutic Agents for Apexogenesis of Immature Permanent Molars: A Randomized Clinical Trial

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2025年3月1日最近更新:
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
75
试验地点
1
主要终点
Clinical outcomes

研究概览

简要总结

The present study will be conducted to clinically evaluation and cone beam computed tomography analysis of amniotic membrane, putty mineral trioxide aggregate and biodentine as therapeutic agents for apexogenesis of immature permanent molars

详细描述

An immature permanent tooth is defined as, a newly erupted permanent tooth with incomplete root apex formation. Since root development is completed in 2-3 years after tooth eruption into the oral cavity, loss of pulp vitality in the immature permanent tooth affected by caries, traumatic injury, or other causes creates major problems. The primary goal of pulp therapy is to maintain the integrity of the teeth while maintaining the vitality of the pulp, especially in young permanent teeth with immature roots to enhance root dentin formation. An increasingly popular therapy option for pulp damage in immature permanent molars is apexogenesis. Vital pulp therapy involves the complete removal of the coronal pulp and the placement of an acceptable material into the pulp chamber. With the invention of calcium silicate material namely mineral trioxide aggregate (MTA), it became preferred to calcium hydroxide in the treatment of exposed pulp. MTA demonstrated excellent biocompatibility, low solubility, outstanding sealing properties and antibacterial effect. However, MTA has some limitations regarding the long setting time and difficult handling. Premixed calcium silicate cements were developed to facilitate manipulation with no need for mixing, such as using the putty formulation which allows better handling with a thicker consistency Additionally, Biodentine was introduced as a tricalcium silicate-based bioceramic, with comparable physical properties to dentine, thus, it is also called dentine replacement material and has applications like those of MTA. Considering the limitations of MTA, biodentine has been developed with enhanced physicochemical properties such as a fast-setting time with an initial setting time between 9 and 12 minutes due to the presence of calcium chloride. Its short setting time allows restoration to be made in one session with easier chairside handling than MTA. Recently, novel biologically based material has been developed from the innermost layer of the placenta with highly rich stem cell reservoirs and is called amniotic membrane. The amniotic membrane is rich in growth factors, various types of collagens (such as types I, III, IV, V, and VII), along with proteoglycans, elastin and hyaluronic acid. It possesses a range of beneficial properties, including anti-inflammatory, antimicrobial and analgesic which make it a unique option for wound healing, providing a supportive environment that promotes the survival and proliferation of mesenchymal progenitor cells. In dentistry, researchers supported its application in regenerative endodontic therapy by providing a growth factors that promote stem cell growth and formation of a new dentine-pulp complex. Therefore, in the present study, clinical and radiographic evaluation will be done to assess the effectiveness of different biomaterials in managing immature permanent tooth with pulp exposure.

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
Single (Participant)

入排标准

年龄范围
7 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Healthy patients without any systemic disease aged 7 to 10 years old.
  • Vital immature permanent molars with deep carious lesions.
  • Restorable tooth
  • No clinical signs and symptoms of irreversible pulpitis including spontaneous pain, tenderness to percussion, swelling or sinus tract.
  • No radiographic evidence of periapical abscess, internal or external resorption.

排除标准

  • Patients with known allergies to any of the dental materials to be used.
  • Bleeding could not be controlled within 5 minutes after complete pulpotomy
  • Teeth with root fractures
  • Carious furcation involvement

研究组 & 干预措施

Biodentine will be placed directly in the pulp chamber

Experimental

干预措施: Vital pulp therapy of immature permanent teeth (Procedure)

Previously trimmed amniotic membrane will be placed directly in the pulp chamber

Experimental

干预措施: Vital pulp therapy of immature permanent teeth (Procedure)

Putty MTA will be placed directly in the pulp chamber

Other

干预措施: Vital pulp therapy of immature permanent teeth (Procedure)

结局指标

主要结局

Clinical outcomes

时间窗: Base line, 7 days, 3 months, 6 months , 12 months

Clinical assessment of the treated immature molars in each follow up period as follow: 1. Presence or Absence of pain or sensitivity to percussion. 2. Presence or absence of any evidence of swelling, or sinus tract. 3. Presence or absence of excessive mobility of the treated teeth .

次要结局

  • Radiographic assessment of root length by CBCT(Baseline (immediately post-operative ) and 12 months post-operative)
  • Radiographic assessment of diameter of apical foramen by CBCT(Baseline (immediately post-operative) and 12 months post-operative))
  • Radiographic assessment of radiographic root area by CBCT(Baseline(immediately post-operative) and at 12 months post-operative)

研究者

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

Sara Mohamed Ezz Eldeen Ghareep

Assistant lecturer

Al-Azhar University

研究点 (1)

Loading locations...

相似试验