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| Name | Class |
|---|---|
| National Research Centre, Egypt | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biodentine Group | Active Comparator | Caries Removal Technique:
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| Diode Laser + Biodentine Group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biodentin | Other | Caries removal performed according to standard clinical protocol, followed by direct placement of Biodentine in the cavity. No laser pre-treatment applied. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Tooth Color (ΔE) | 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. | 3 and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Research Center | Giza | Giza Governorate | 12622 | Egypt |
Individual participant data will not be shared publicly because this is an investigator-initiated academic study conducted at the National Research Centre. Data sharing is restricted by institutional policies and the conditions of ethics committee approval, and the informed consent obtained from participants does not include permission for public sharing of individual-level data.
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| 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:
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| Pulp Vitality Status | 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 and 6 months |
| Periapical Clinical Status | 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. | 3 months and 6 months |
| ID | Term |
|---|---|
| D014075 | Tooth Discoloration |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D054023 | Lasers, Semiconductor |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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