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临床试验/NCT06934317
NCT06934317Enrolling By Invitation不适用

Maximum Occlusal Bite Force of Necrotic Mature and Immature Permanent Teeth pre-and Post-treatment With the Available Treatment Modalities: Randomized Clinical Trial

Lama Awawdeh1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年12月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
40
试验地点
1
主要终点
clinical signs and symptoms

研究概览

简要总结

Further investigation is warranted to ascertain whether the regaining of sensibility and nerve function in regenerated teeth leads to the re-establishment of the proprioceptive protective mechanism inherent in vital teeth.

Hence, the primary objective of this prospective randomized clinical trial is to conduct a comparative analysis of the potential effects of pulp revascularization in comparison to conventional endodontic treatments, either RCT or apexification on the Maximum occlusal bite force (MBF) in both immature and mature necrotic permanent teeth.

Methods: Upon satisfying the predetermined criteria for inclusion, a total of 184 patients will be recruited for this prospective clinical trial. The study will consist of two groups, specifically Group I: Mature teeth and Group II: Immature teeth, with a sample size of 92 participants in each group. The participants will be assigned randomly to one of the two treatment modalities per group. Group I: will undergo treatment with RCT/revascularization, while Group II will receive MTA plug/revascularization encompassing both mature (n=92) and immature teeth (n=92). MBF will be measured on the selected necrotic teeth prior to clinical intervention, this measurement will be conducted using a portable occlusal force gauge (GM10). Following the completion of therapy, MBF measurements will be repeated at 6 and 12 months to assess long-term outcomes. Subsequently, the collected data will undergo comprehensive analysis.

详细描述

The maximum bite force (MBF) or masticatory force results from the contact of the maxillary and mandibular teeth with the bones and muscles of the jaw [1,2,3].

Although, it is well known that the protective reflex with the jaw elevator muscle is initiated through the activation of mechanoreceptors located within the periodontal ligament [3,4,5,6]. Several studies in the literature have provided compelling evidence supporting the involvement of dental pulp in the reflex withdrawal reaction and its ability to mediate proprioceptive functions via intradental mechanoreceptors. These mechanoreceptors play a crucial role in transmitting tactile impulses through fast conducting A-delta and A-beta fibres, ultimately reaching the principal sensory nucleus of the trigeminal nerve [7-11].

Henceforth, subsequent carrying out of root canal treatment (RCT) and apexification, which are widely recognised as conventional treatment approaches for necrotic mature and immature teeth respectively, it seems that a portion of the protective mechanism and stress reduction effect is compromised due to the removal of pulpal tissue [12]. Consequently, diminished ability to control the strain exerted on dentin, along with changes in the mechanical and physical characteristics of dentin and loss of tooth structure during cavity preparation and instrumentation. Thus, the tooth becomes more susceptible to occlusal forces, thereby elevating the risk of fracture [13-15]. This has been tested by previous studies, which have demonstrated that MBF is greater in teeth that have undergone endodontic treatment than in vital contralateral teeth [8,16]. Therefore, the alternative path in which endodontics is moving is towards regenerative endodontic procedures (REPs) rather than replacing tissues with artificial alternatives.

Regenerative endodontic procedures are defined as "biologically based procedures designed to replace damaged structures, including dentin and root structures, as well as cells of the pulp-dentin complex" [17]. It capitalizes on the presence of undifferentiated mesenchymal stem cells (MSCs) within the periapical tissues. These cells gain access to the root canal after over-instrumentation of the apex [18]. Additionally, the growth factors present in the dentine play a pivotal role in directing the migration, proliferation, and differentiation of these stem cells, which possess the ability to regenerate the pulp-dentin complex.

REPs have been widely recognized as a clinically effective treatment modality, as numerous clinical studies and case reports have shown favorable outcomes in terms of root development, apical closure, periapical lesion healing, and symptoms resolution in the majority of treated mature and immature teeth [19-26].

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Participant)

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
否

入选标准

  • •Healthy (ASA Grade 1 & 2 status). Compliant patient/parent. Mature and immature teeth diagnosed with necrotic pulp. Pulp space is not needed for post and core restoration for cases treated by revascularization.
  • •Patients are not allergic to the medications necessary to complete the procedure.
  • •The presence of opposing teeth for the included necrotic teeth. No medication (steroids) at the time of investigation, and the patient should not have taken analgesics 6 hours ago.

排除标准

  • •Medically compromised patient. Patient with generalized chronic periodontitis. Patient with TMD. Current orthodontic treatment. Teeth with sensitivity to percussion. Teeth with previous root canal treatment. Periodontal pocket more than 3mm. Teeth with vertical fractures. Teeth with large restorations, either direct or indirect restoration Teeth with large carious lesions. Non-restorable teeth.

研究组 & 干预措施

Induced bleeding mature and immature group

Experimental

Regeneration procedures will be conducted in two appointments, adhering to the 'Clinical Considerations for a Regenerative Procedure' proposed by the American Association of Endodontists (AAE) in 2021. All cases will receive a permanent restoration as a final restoration and a post-operative periapical radiograph

干预措施: measurement of maximum bite force using bite fork (Diagnostic Test)

Induced bleeding mature and immature group

Experimental

Regeneration procedures will be conducted in two appointments, adhering to the 'Clinical Considerations for a Regenerative Procedure' proposed by the American Association of Endodontists (AAE) in 2021. All cases will receive a permanent restoration as a final restoration and a post-operative periapical radiograph

干预措施: pulp revascularization by induced bleeding (Procedure)

root canal treated mature group

Placebo Comparator

conventional root canal treatment in mature necrotic teeth with periapical lesion

干预措施: measurement of maximum bite force using bite fork (Diagnostic Test)

root canal treated mature group

Placebo Comparator

conventional root canal treatment in mature necrotic teeth with periapical lesion

干预措施: conventional root canal treatment (Procedure)

MtA apexification

Placebo Comparator

which includes the immature necrotic permanent teeth, will randomly receive either MTA apexification or revascularization

干预措施: measurement of maximum bite force using bite fork (Diagnostic Test)

MtA apexification

Placebo Comparator

which includes the immature necrotic permanent teeth, will randomly receive either MTA apexification or revascularization

干预措施: MTA apexification (Procedure)

结局指标

主要结局

clinical signs and symptoms

时间窗: in 3, 6 and 12 months intervals

absence of pain, tenderness, and evidence of radiographic healing

次要结局

  • assesment of pulp vitality(in 6 and 12 months intervals)

研究者

发起方
Lama Awawdeh
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lama Awawdeh

Professor

King Abdullah University Hospital

研究点 (1)

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