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

Misr International University

Status: Active, not recruiting

Conditions: Deep Carious Lesion; Deep Caries Lesion of Pemanent Teeth; Patients With Deep Carious Lesions

Treatments: Device: Diode laser; Other: Biodentin

Study type: Interventional

Funder types: Other

Identifiers

NCT07358442

MREC-IRB-03441225

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. tooth-related criteria included reversible pulpitis or asymptomatic restorable vital permanent posterior molar. (based on clinical and radiographic examination, pulp vitality tests).
3. Radiographic evidence of deep caries approaching the pulp (e.g., inner half of dentin).
4. No signs of irreversible pulpitis or periapical pathology.

Exclusion criteria

1. Patients undergoing orthodontic treatment or with significant periodontal disease affecting the study tooth or who cannot tolerate CBCT scanning.
2. patients who are medically compromised (systemic diseases affecting bone metabolism or healing (e.g., uncontrolled diabetes)).
3. pregnant ladies, patients with allergy to any component of Biodentine or other materials used, and patients who are not cooperative.
4. 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 ).
5. Teeth with periapical radiolucency and have been already restored before (previous endodontic treatment)
6. Extensive tooth destruction requiring full coronal coverage.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups

Biodentine Group

Active Comparator group

Description:

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

Treatment:

Other: Biodentin

Diode Laser + Biodentine Group

Experimental group

Description:

* 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

Treatment:

Device: Diode laser