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NCT Number: NCT07358442

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Research Center

Giza, Giza Governorate, 12622, Egypt

About this study

Deep carious lesions present a clinical challenge due to the need to remove infected dentin while preserving pulp vitality and preventing postoperative complications. Contemporary minimally invasive dentistry emphasizes selective caries removal and the use of bioactive materials to promote pulp healing and reparative dentin formation.

Biodentine is a calcium silicate-based bioactive cement widely used in vital pulp therapy and indirect pulp capping. It provides favorable sealing ability, biocompatibility, and the potential to stimulate reparative dentinogenesis. However, concerns remain regarding the preservation of dentin thickness and the risk of postoperative tooth discoloration when used in deep cavities.

Diode lasers have been introduced as an adjunctive modality in deep caries management due to their antimicrobial effects, ability to achieve hemostasis, and potential to modify dentin surface characteristics prior to placement of restorative materials. Laser pre-treatment may therefore influence clinical outcomes when used before Biodentine application.

This randomized controlled clinical trial is designed to compare two treatment approaches for deep carious lesions in vital posterior teeth. In the control group, selective caries removal will be performed followed by placement of Biodentine. In the experimental group, diode laser pre-treatment of the cavity will be applied prior to Biodentine placement. All procedures will be carried out under rubber dam isolation and standardized aseptic conditions.

Changes in dentin thickness and radiographic density of the remaining dentin will be evaluated using cone beam computed tomography at baseline and during follow-up visits at 3 and 6 months. Tooth color changes will be assessed using standardized digital photography and spectrophotometric analysis. Pulp vitality will be evaluated using cold testing and electric pulp testing, and periapical clinical status will be assessed through percussion, palpation, and tooth mobility examination.

The primary objective of this study is to compare changes in dentin thickness between Biodentine alone and diode laser pre-treatment followed by Biodentine. Secondary objectives include evaluation of radiographic dentin density, tooth color changes, pulp vitality status, and periapical clinical status over a 6-month follow-up period.

This study aims to determine whether diode laser pre-treatment provides additional clinical benefit when used prior to Biodentine application in the management of deep carious lesions.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged [ 18-45 years] requiring treatment for a single deep carious lesion and willing to provide informed consent and comply with follow-up appointments. Candidates with good general health.
  • tooth-related criteria included reversible pulpitis or asymptomatic restorable vital permanent posterior molar. (based on clinical and radiographic examination, pulp vitality tests).
  • Radiographic evidence of deep caries approaching the pulp (e.g., inner half of dentin).
  • No signs of irreversible pulpitis or periapical pathology.

Exclusion criteria

  • Patients undergoing orthodontic treatment or with significant periodontal disease affecting the study tooth or who cannot tolerate CBCT scanning.
  • patients who are medically compromised (systemic diseases affecting bone metabolism or healing (e.g., uncontrolled diabetes)).
  • pregnant ladies, patients with allergy to any component of Biodentine or other materials used, and patients who are not cooperative.
  • Tooth-related criteria involved teeth that have irreversible pulpitis or necrotic pulp (based on symptoms and vitality tests; spontaneous pain, or sustained pain after vitality tests (electrical or cold tests), teeth with pain on percussion ).
  • Teeth with periapical radiolucency and have been already restored before (previous endodontic treatment)
  • Extensive tooth destruction requiring full coronal coverage.

Treatment and study plan

Biodentin

Other

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

Diode laser

Device

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.

Primary outcomes

  1. Change in Dentin Thickness

    Time frame: 3 and 6 months

    To evaluate and compare the change in dentin thickness in deep carious lesions treated with Biodentine alone versus diode laser pre-treatment followed by Biodentine using cone beam computed tomography (CBCT).

    Cranex 3D, Soredex, Finland CBCT machine will be used to assess the dentin thickness in Millimeters (mm) by using the linear measurement tool and measuring the distance from the base of restoration to the pulp on sagittal, coronal or cross sectional images generated from CBCT scans after orientation of the orthogonal planes using the software vertical and horizontal reference lines

  2. Radiographic Density of Remaining Dentin

    Time frame: 3 months and 6 months

    To evaluate and compare the radiographic density of the remaining dentin beneath deep carious lesions treated with Biodentine alone versus diode laser pre-treatment followed by Biodentine using CBCT density measurement tools with Gray scale value (CBCT density units).

Secondary outcomes

  1. Change in Tooth Color (ΔE)

    Time frame: 3 and 6 months

    To assess and compare the change in tooth color in teeth treated with Biodentine alone versus diode laser pre-treatment followed by Biodentine using standardized digital photography and spectrophotometric analysis. The total color difference (ΔE) will be calculated based on the CIE L*a*b* color system.

  2. Pulp Vitality Status

    Time frame: 3 and 6 months

    To assess and compare pulp vitality status (vital/ non vital) as binary outcome in both treatment groups using cold stimulus testing and electric pulp testing.

  3. Periapical Clinical Status

    Time frame: 3 months and 6 months

    To assess and compare periapical clinical status as binary outcome (Presence or absence of clinical signs and symptoms) in both groups using percussion, palpation, and tooth mobility examination.

Sponsors and collaborators

Lead sponsor

Misr International University

Other

Collaborators

  • National Research Centre, Egypt

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 22, 2026
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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