Caries Removal Methods and Microbiome Changes

NCT07538089 | Active Not Recruiting

• 2 other identifiers: 2024/11762025-SA.KAP-6
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Caries, Dental

Keywords

Dental caries; Cavity microbiome

Outcome Measures

Primary Outcomes (1)

• Microbiome Changes

  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.

  3 months

Secondary Outcomes (4)

• 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

Study Arms (2)

Non-selective caries removal

EXPERIMENTAL

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

Procedure: Non-selective caries removal

Selective caries removal

EXPERIMENTAL

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

Procedure: Selective caries removal

Interventions

Non-selective caries removal PROCEDURE

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.

Also known as: Complete caries removal

Non-selective caries removal

Selective caries removal PROCEDURE

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.

Also known as: Partial caries removal

Selective caries removal

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nuh Naci Yazgan University: lead

Study Sites (1)

Nuh Naci Yazgan University Faculty of Dentistry

Kayseri, Kocasinan, 38170, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

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

Study Record Dates

• First Submitted: April 12, 2026
• First Posted: April 20, 2026
• Study Start: February 26, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

TU (1)