跳至主要内容
临床试验/NCT05667545
NCT05667545已完成1 期

Evaluation of the Remineralizing Effect of Self-assembling Peptide P11-4 on Caries Affected Dentin.

Egymedicalpedia1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
30
试验地点
1
主要终点
Remineralization

研究概览

简要总结

Dental caries is a biofilm-mediated, sugar-driven, multifactorial, dynamic disease that results in the phasic demineralization and remineralization of dental hard tissues.

These tissues have poor regeneration capability because of the lack of both regenerative cells and vascularization.

In the complex caries progression process involving dietary sugars, bacterial metabolism and demineralization, the collagenous organic matrix becomes exposed and destroyed by resident and bacterial proteases, allowing the lesion to expand

详细描述

It is possible to find numerous noninvasive or minimally invasive therapies for caries such as hygiene education, fluorides, Phosphopeptide compounds, xylitol and infiltrative resins.

However, when caries progresses to the point of breaking down the dental tissues, composite restorations are imperative to preserve the tooth functionality.

During the execution of routine dental restorations, the hybrid structure formed by the dental bonding procedure occurs through the interaction and subsequent polymerization of monomers around the demineralized collagen matrix.

The oral cavity is a severe environment for the resin-dental bond to survive for a reasonable length of time, with thermomechanical changes, chemical attacks by acids and enzymes and other factors posing routine daily challenges. Therefore to achieve effective and stable bonding, the preservation of dentin collagen is critical, since collagen represents the major organic component of the dentin matrix.

Based on today's understanding of the dental biomineralization process, new efforts have been made to develop synthetic analogues of non-collagenous proteins (NCPs), which are involved in the events of nucleation and growth of hydroxyapatite crystals in hard tissues Such analogues have been designed mirroring the amphiphilic characteristics of NCPs, with polar groups complexing inorganic ions and non-polar side chains governing the matrix-matrix interactions.

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
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients included in the study will be required to present at least one permanent molar with an active deep carious lesion without pulpal involvement.
  • Age of patient: 18 -30 years
  • Carious lesions will be standardized by means of clinical and radiographic examinations performed before the procedures

排除标准

  • Teeth with deep dentinal lesions with pulpal involvement, abscess, pain or swelling
  • Developmental disorders and adjacent soft tissue lesions
  • Patients with systemic illness will be excluded

研究组 & 干预措施

Negative control group (A1)

Active Comparator

A1: cavities will be sealed directly by restorative material (conventional glass ionomer) without any treatment.

干预措施: Peptide (Drug)

Treatment group (A2)

Active Comparator

A2: cavities will be treated by Self-Assembling peptide P11-4 then sealed by conventional glass ionomer.

干预措施: Peptide (Drug)

结局指标

主要结局

Remineralization

时间窗: 3 months

Assessment of the remineralizing effect of self-assembling peptide P11-4 on affected-caries dentin. Remineralization will be assessed by radiodensity using digital radiography

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验