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Caries Removal Methods and Microbiome Changes

Microbiome Changes in Cavities Prepared With Different Caries Removal Methods

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07538089
Enrollment
48
Registered
2026-04-20
Start date
2026-02-26
Completion date
2026-08-01
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caries, Dental

Keywords

Dental caries, Cavity microbiome

Brief summary

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.

Detailed description

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. However, clinical evidence evaluating the impact of selective versus non-selective caries removal on the cavity microbiome using 16S rRNA sequencing remains scarce. Given that the quantity and quality of residual dentin may influence both mechanical properties and microbial persistence, elucidating these effects is critical for advancing biologically driven treatment strategies. The aim of this study is to compare 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 provide insights into the microbiological outcomes of minimally invasive approaches and to inform the development of optimized clinical protocols that balance dentin preservation with effective microbial control.

Interventions

Non-selective caries removal involves the complete excavation of infected dentin using conventional rotary instruments. Both infected and affected dentin are removed until hard dentin is reached, aiming to eliminate all carious tissue.

Selective caries removal involves complete caries removal at the cavity margins while preserving softened dentin near the pulp to reduce the risk of pulp exposure and maintain tooth vitality.

Sponsors

Nuh Naci Yazgan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Intervention model description

Group 1: Non-selective caries removal (complete excavation of infected dentin) Group 2: Selective caries removal (preservation of affected dentin near the pulp)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Microbiome Changes3 monthsIn 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.

Secondary

MeasureTime frameDescription
Relative abundance of specific bacterial taxa3 monthsMeasured using 16S rRNA sequencing to evaluate changes in key cariogenic and commensal bacteria after caries removal procedures.
Alpha diversity of the oral microbiome3 monthsAssessed using diversity indices (e.g., Shannon index) to evaluate microbial richness and diversity within samples.
Beta diversity of the oral microbiome3 monthsEvaluated to compare differences in microbial community composition between study groups.
Presence of residual cariogenic bacteria3 monthsAssessment of remaining cariogenic microorganisms in the cavity after caries removal.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 21, 2026