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临床试验/NCT07538089
NCT07538089进行中(未招募)不适用

Microbiome Changes in Cavities Prepared With Different Caries Removal Methods

Nuh Naci Yazgan University1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2026年2月26日最近更新:
适应症
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
48
试验地点
1
主要终点
Microbiome Changes

研究概览

简要总结

Dental caries management approaches may influence not only tissue removal but also the microbial composition within the cavity. However, clinical evidence on how different caries removal methods affect the oral microbiome remains limited.

This study aims to evaluate the effects of selective and non-selective caries removal methods on the diversity and composition of the oral microbiome using 16S rRNA gene sequencing. The findings are expected to help identify biologically compatible treatment approaches that effectively reduce pathogenic microorganisms.

详细描述

Dental caries is a highly prevalent chronic disease and a major cause of tooth loss, arising from a disruption in the dynamic balance between demineralization and remineralization processes. Acidogenic microorganisms within the oral biofilm drive mineral loss in enamel and dentin, leading to lesion progression.

Beyond mechanical debridement, the method of caries removal plays a critical role in modulating the residual microbial environment and influencing the biological response of the pulp-dentin complex. Conventional (non-selective) caries removal aims to eliminate all infected dentin; however, this approach may result in excessive tissue removal, including dentin with remineralization potential, and may increase the risk of pulpal stress or exposure.

In contrast, minimally invasive dentistry emphasizes the preservation of tooth structure and the maintenance of pulp vitality. Selective caries removal has emerged as a biologically oriented strategy in which caries is completely removed at the periphery of the cavity while softened dentin adjacent to the pulp is preserved. This approach is designed to reduce the risk of pulp exposure and to support the reparative and remineralization capacity of the remaining dentin.

Despite increasing clinical adoption, the microbiological consequences of different caries removal strategies remain incompletely understood. Traditional culture-based methods provide limited insight into the complexity of the oral microbiota, as a substantial proportion of oral microorganisms cannot be cultivated under standard laboratory conditions.

The advent of 16S rRNA gene sequencing has enabled high-resolution, culture-independent characterization of microbial communities, offering a comprehensive view of microbial diversity and composition within carious lesions. This approach provides an opportunity to better understand how clinical interventions shape the oral microbiome.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Permanent molar or premolar teeth with carious lesions located on the occlusal surface and extending no deeper than the middle third of dentin
  • Individuals with good oral hygiene
  • Absence of clinical signs or symptoms of periapical pathology
  • Teeth in occlusion with the opposing dentition
  • Individuals aged between18-40 years
  • Individuals who provide written informed consent

排除标准

  • Teeth with pulpal exposure or irreversible pulpitis
  • Presence of periapical pathology
  • Poor oral hygiene
  • Patients with systemic conditions affecting oral health or healing
  • Use of antibiotics within the last 3 months
  • Pregnant or lactating individuals

研究组 & 干预措施

Non-selective caries removal

Experimental

Complete removal of infected dentin using the non-selective caries removal approach.

干预措施: Non-selective caries removal (Procedure)

Selective caries removal

Experimental

Selective removal of carious tissue with preservation of softened dentin near the pulp.

干预措施: Selective caries removal (Procedure)

结局指标

主要结局

Microbiome Changes

时间窗: 3 months

In all groups, dentin samples will be taken from the affected dentin at the base of the cavity after caries removal using two sterile, size 6 round steel burs moistened with saline solution for microbial analysis. The burs will be placed in 5 ml sterile vials and stored at -80 0C until the analyses are performed. The prepared cavities will be completed with routine and standard treatment protocols. Following the finishing and polishing procedures, occlusion will be checked. The samples collected during the research process will be delivered to the A\&D Genetic Diseases Evaluation Centre (Ankara, Turkey) where DNA isolation and sequence analysis will be performed together with molecular biologists. In the method, following the extraction of total genomic DNA from clinical samples, broad-range 16S rRNA PCR will be performed and MicroSeq 500 16S rRNA Sequencing kit will be used for sequence analysis.

次要结局

  • Relative abundance of specific bacterial taxa(3 months)
  • Alpha diversity of the oral microbiome(3 months)
  • Beta diversity of the oral microbiome(3 months)
  • Presence of residual cariogenic bacteria(3 months)

研究者

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

Ozcan Karatas

Associate Professor

Nuh Naci Yazgan University

研究点 (1)

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