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A Comparative Clinical Study Assessing Dentin Thickness and Discoloration in Deep Carious Lesions Treated With Biodentine Alone Versus Diode Laser Pre-treatment Followed by Biodentine

NCT07358442 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-01-22

No results posted yet for this study

Summary

This interventional clinical study aims to compare dentin thickness preservation and tooth discoloration in deep carious lesions treated with Biodentine alone versus diode laser pre-treatment followed by Biodentine. Participants with deep carious lesions will be allocated to one of two treatment protocols, and clinical and radiographic assessments will be performed to evaluate outcomes. The findings of this study may provide evidence on whether diode laser pre-treatment offers additional clinical benefits when used prior to Biodentine application in the management of deep caries.

Conditions

  • Patients With Deep Carious Lesions
  • Deep Caries Lesion of Pemanent Teeth
  • Deep Carious Lesion

Interventions

OTHER

Biodentin

Caries removal performed according to standard clinical protocol, followed by direct placement of Biodentine in the cavity. No laser pre-treatment applied.

DEVICE

Diode laser

Deep carious lesions are treated with diode laser pre-treatment (A 940 nm diode laser (EPIC X™, BIOLASE, USA) will be used immediately after exposure control. o Laser Parameters: * Wavelength: 940 nm * Output Power: 0.1 W * Mode: Continuous Wave * Duration: 10 seconds * Spot Size: 200 µm fiber tip * Technique: Non-contact, sweeping motion across the exposure site at a distance of approximately 1 mm from the pulp surface) followed by placement of Biodentine according to standard clinical protocol.

Sponsors & Collaborators

  • National Research Centre, Egypt

    collaborator OTHER

  • Misr International University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-30
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07358442 on ClinicalTrials.gov