Patients With Deep Carious LesionsNCT07358442
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
A study testing Biodentin and Diode laser in people with Patients With Deep Carious Lesions and Deep Caries Lesion of Pemanent Teeth, run by Misr International University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Patients With Deep Carious Lesions, Deep Caries Lesion of Pemanent Teeth, Deep Carious Lesion
- What is being tested?
- Biodentin and Diode laser
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jul 2025to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Patients With Deep Carious Lesions, Deep Caries Lesion of Pemanent Teeth, Deep Carious Lesion
- Being tested
- Biodentin, Diode laser
- Keywords
- Vital pulp therapy, Biodentine, Diode laser, Cone beam computed tomography, Dentin bridge, Tooth discoloration, Pulp vitality, Deep carious lesions
- Medical subject headings
- Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiodentinOther
Caries removal performed according to standard clinical protocol, followed by direct placement of Biodentine in the cavity. No laser pre-treatment applied.
Diode laserDevice
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.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Diode laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: 3 months and 6 months
Secondary outcomes (3)
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.
Measured: 3 and 6 months
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.
Measured: 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.
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start30 Jul 2025
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Deep Carious LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Misr International University
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Centre, Egypt
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07358442
- Sponsor's protocol ID
- MREC-IRB-03441225
- Status last verified
- Jul 2025
- First submitted
- 2 Jan 2026
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07358442
- Acronym / sponsor ID
- MREC-IRB-03441225
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Misr International UniversityUniversity, hospital or other
- Collaborators
- National Research Centre, Egypt
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biodentine Group | Active comparator | Other: BiodentinCaries 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 |
| Diode Laser + Biodentine Group | Experimental | Device: Diode laser* 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiodentinCaries removal performed according to standard clinical protocol, followed by direct placement of Biodentine in the cavity. No laser pre-treatment applied. | Other | Biodentine Group |
| Diode laserDeep 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. | Device | Diode Laser + Biodentine Group |
Primary outcome
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
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).
3 secondary outcomes
Change in Tooth Color (ΔE)
Time frame: 3 and 6 months
Pulp Vitality Status
Time frame: 3 and 6 months
Periapical Clinical Status
Time frame: 3 months and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Patients With Deep Carious Lesions
Not yet recruitingPhase 2
A Clinical Study of KH001 for Pulp Preservation and Safety in Deep Dentin Caries
Dental Caries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biodentin and Diode laser in people with Patients With Deep Carious Lesions and Deep Caries Lesion of Pemanent Teeth, run by Misr International University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dentin Thickness (time frame: 3 and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.