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 | Active Not Recruiting DMC

• 1 other identifier: MREC-IRB-03441225
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Vital pulp therapy; Biodentine; Diode laser; Cone beam computed tomography; Dentin bridge; Tooth discoloration; Pulp vitality; Deep carious lesions

Outcome Measures

Primary Outcomes (2)

• Change in Dentin Thickness

  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

  3 and 6 months

• Radiographic Density of Remaining Dentin

  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).

  3 months and 6 months

Secondary Outcomes (3)

• Change in Tooth Color (ΔE)

  3 and 6 months

• Pulp Vitality Status

  3 and 6 months

• Periapical Clinical Status

  3 months and 6 months

Study Arms (2)

Biodentine Group

ACTIVE COMPARATOR

Caries Removal Technique: * Caries removal will follow the selective caries removal to soft dentin technique. * Occlusal undermined enamel will be eliminated using a #245 high-speed carbide bur to improve visibility and access. * A spoon excavator will be used to remove soft, infected dentin from the cavity walls and floor. * Firm, discolored, but leathery dentin near the pulp will be removed with a slow-speed sterile carbide round bur to minimize pulp exposure risk. * In cases of mechanical pinpoint pulp exposure, minimal bleeding will be controlled using a wet cotton pellet followed by a dry pellet with gentle pressure. • Pulp Protection: * Biodentine capsule (Septodont, Sain- Maur-des-Fosses, France) will be mixed and placed directly over the exposure site according to the manufacturer's instructions. * Application of Biodentine on the exposure site as following ; first keeping the capsule in upright position to remove the white cap and place the open capsule into the stand and ope

Other: Biodentin

Diode Laser + Biodentine Group

EXPERIMENTAL

* Caries Removal Technique: o Identical to Group 1, including selective caries removal and hemostasis measures upon exposure. * Diode Laser Application: * A 940 nm diode laser (EPIC X™, BIOLASE, USA) will be used immediately after exposure control. * 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. * Safety Measures: * All individuals present (patient, operator, assistant) will wear laser-specific protective goggles. * Laser warning signs will be displayed to ensure no interruption during application. * The laser unit will be calibrated prior to each use, and its output power will be verified using a laser power meter. * Pulp Protection: * Following laser application, Biodentine will be applied to the exposure site then restored the same as biodentin group

Device: Diode laser

Interventions

Biodentin OTHER

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

Biodentine Group

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.

Diode Laser + Biodentine Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Misr International University: lead
• National Research Centre, Egypt: collaborator

Study Sites (1)

National Research Center

Giza, Giza Governorate, 12622, Egypt

Location

MeSH Terms

Conditions

Tooth Discoloration

Interventions

Lasers, Semiconductor

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2026
• First Posted: January 22, 2026
• Study Start: July 30, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 22, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)