Deep Carious LesionsNCT07171775
This Study Aims to Clinically Assess and Radiographically Measure the Formed Dentin Bridge Over the Pulp, Utilizing Three-dimensional Imaging Following the Application of a Bioactive Restorative System Versus a Conventional Restorative System After Selective Caries Removal to Soft Dentin Over 2
A study testing Experimental - Bioactive Restorative System and Active Comparator -Conventional Restorative System in people with Deep Carious Lesions and Partial Caries Removal, run by Cairo University.
Trial summary
This clinical trial aims to evaluate dentin bridge formation over the pulp following selective caries removal in permanent teeth with deep carious lesions (ICDAS scores 5-6). A total of 66 patients will be enrolled and randomly allocated to receive either a bioactive restorative system (bioactive universal adhesive… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Deep Carious Lesions, Partial Caries Removal, Dentin Bridge
- What is being tested?
- Experimental - Bioactive Restorative System and Active Comparator -Conventional Restorative System
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Jun 2028
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient-related criteria:
- Adult patients (age: 18-40 years) of both genders.
- Good oral hygiene.
- Willing to sign the informed consent.
- Cooperative patients who accept the follow-up period.
- Tooth-related criteria:
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- Posterior permanent caries (ICDAS 5-6).
- Radiographically, caries is extending 50% of dentine with a radiopaque layer between the carious lesion and the pulp chamber.
- Sensitive teeth according to the cold pulp test.
- Negative response in percussion test.
Who cannot join
- Patient-related criteria:
- Allergy to any of the restorative materials.
- Patients undergoing orthodontic treatment with fixed appliances.
- Pregnant women.
- Patients with debilitating systemic diseases.
- Patient who frequently uses analgesics or any drugs that could mask the pain.
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- Tooth-related criteria:
- Teeth with previous restorations.
- Spontaneous pain or prolonged pain (more than 15 s) after the sensitivity test (cold test), which would indicate irreversible pulpitis.
- Negative sensibility tests, periapical radiolucency, and sensitivity to axial or lateral percussion.
- Mobile teeth, indicating periodontal disease or trauma.
- External or internal resorption.
- Chipped teeth or Cuspal loss
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Esraa Hamdy Saber E.H. Assistant lecturer, PhD contact
About this study
Official title: Clinical and Three-Dimensional Radiographic Assessment of Bioactive Restorative System Following Selective Caries Removal of Deep Lesions: A Two-Year Randomized Controlled Trial
This clinical trial aims to evaluate dentin bridge formation over the pulp following selective caries removal in permanent teeth with deep carious lesions (ICDAS scores 5-6). A total of 66 patients will be enrolled and randomly allocated to receive either a bioactive restorative system (bioactive universal adhesive combined with a bioactive bulk-fill resin composite) or a conventional non-bioactive restorative system. Clinical assessments, including pulp sensibility testing and patient-reported pain evaluation, together with three-dimensional radiographic analysis using cone beam computed tomography, will be conducted to assess the thickness and quality of reparative dentin bridge formation. Outcomes will be evaluated at baseline and during follow-up periods extending up to 24 months to compare the effectiveness of both restorative approaches in preserving pulp sensibility and promoting dentin-pulp complex repair.
Read the detailed description
This randomized controlled clinical trial is designed to evaluate the clinical and radiographic outcomes of a bioactive restorative system compared with a conventional restorative system following selective caries removal in permanent molars with deep carious lesions (ICDAS scores 5-6).
A total of 66 eligible patients will be recruited according to predefined inclusion and exclusion criteria and randomly allocated into two parallel groups. After selective removal of carious dentin to soft dentin, cavities will be restored using either a bioactive restorative system (bioactive universal adhesive combined with bioactive bulk-fill resin composite) or a non-bioactive restorative system (conventional universal adhesive and bulk-fill resin composite).
Clinical assessments will include evaluation of pulp sensibility and patient-reported pain, while radiographic assessment of dentin bridge formation-regarding presence, thickness, and quality-will be performed using three-dimensional cone beam computed tomography. Outcomes will be evaluated at baseline and during follow-up periods extending up to 24 months to compare the effectiveness of both restorative approaches in preserving pulp vitality and promoting dentin-pulp complex repair
- Conditions
- Deep Carious Lesions, Partial Caries Removal, Dentin Bridge
- Being tested
- Experimental - Bioactive Restorative System, Active Comparator -Conventional Restorative System
- Keywords
- deep caries, partial caries removal, selective caries removal, dentin bridge, Bioactive, universal adhesive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental - Bioactive Restorative SystemProcedure or surgery
Following selective caries removal to soft dentin, the cavity will be restored using a bioactive restorative system consisting of a bioactive universal adhesive followed by placement of a bioactive bulk-fill resin composite.
Active Comparator -Conventional Restorative SystemProcedure or surgery
Following selective caries removal to soft dentin, the cavity will be restored using a conventional universal adhesive system followed by placement of a bulk-fill resin composite
| Study group | Role | What they receive |
|---|---|---|
| Bioactive Restorative System | Experimental | Experimental Group (Bioactive Restorative System): Receives: Procedure: Experimental - Bioactive Restorative System |
| Conventional Restorative System | Active comparator | Control Group (Conventional Restorative System) Receives: Procedure: Active Comparator -Conventional Restorative System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical assessment of Pulp sensibility.
Thermal pulp test
Measured: 24 months
Secondary outcomes (2)
Clinical assessment of pain.
(Patient-reported outcome measures) by Visual analogue scale The Visual Analogue Scale (VAS) will be used, by which 0 is no pain and 10 is severe pain.
Pictures will be added to the same, as well as colors to guide the patient during selection of pain severity.
Measured: 24 months
Thickness and quality of Dentin bridge formation
Assess the dentin thickness 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's vertical and horizontal reference lines
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start1 Jun 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Carious LesionsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Hamdy Saber Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07171775
- Sponsor's protocol ID
- CU-2025-09
- Status last verified
- Jan 2026
- First submitted
- 6 Sep 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Three-Dimensional Radiographic Assessment of Bioactive Restorative System Following Selective Caries Removal of Deep Lesions: A Two-Year Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07171775
- Acronym / sponsor ID
- CU-2025-09
- Conditions
- Deep Carious Lesions, Partial Caries Removal, Dentin Bridge
- Keywords
- deep caries, partial caries removal, selective caries removal, dentin bridge, Bioactive, universal adhesive
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 15 Sep 2025 (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 clinical trial aims to evaluate dentin bridge formation over the pulp following selective caries removal in permanent teeth with deep carious lesions (ICDAS scores 5-6). A total of 66 patients will be enrolled and randomly allocated to receive either a bioactive restorative system (bioactive universal adhesive combined with a bioactive bulk-fill resin composite) or a conventional non-bioactive restorative system. Clinical assessments, including pulp sensibility testing and patient-reported pain evaluation, together with three-dimensional radiographic analysis using cone beam computed tomography, will be conducted to assess the thickness and quality of reparative dentin bridge formation. Outcomes will be evaluated at baseline and during follow-up periods extending up to 24 months to compare the effectiveness of both restorative approaches in preserving pulp sensibility and promoting dentin-pulp complex repair.
Detailed description
This randomized controlled clinical trial is designed to evaluate the clinical and radiographic outcomes of a bioactive restorative system compared with a conventional restorative system following selective caries removal in permanent molars with deep carious lesions (ICDAS scores 5-6).
A total of 66 eligible patients will be recruited according to predefined inclusion and exclusion criteria and randomly allocated into two parallel groups. After selective removal of carious dentin to soft dentin, cavities will be restored using either a bioactive restorative system (bioactive universal adhesive combined with bioactive bulk-fill resin composite) or a non-bioactive restorative system (conventional universal adhesive and bulk-fill resin composite).
Clinical assessments will include evaluation of pulp sensibility and patient-reported pain, while radiographic assessment of dentin bridge formation-regarding presence, thickness, and quality-will be performed using three-dimensional cone beam computed tomography. Outcomes will be evaluated at baseline and during follow-up periods extending up to 24 months to compare the effectiveness of both restorative approaches in preserving pulp vitality and promoting dentin-pulp complex repair
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bioactive Restorative System | Experimental | Procedure: Experimental - Bioactive Restorative SystemExperimental Group (Bioactive Restorative System): |
| Conventional Restorative System | Active comparator | Procedure: Active Comparator -Conventional Restorative SystemControl Group (Conventional Restorative System) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Adult patients (age: 18-40 years) of both genders.
- Good oral hygiene.
- Willing to sign the informed consent.
- Cooperative patients who accept the follow-up period.
- Posterior permanent caries (ICDAS 5-6).
Key exclusion criteria (13 listed)
- Allergy to any of the restorative materials.
- Patients undergoing orthodontic treatment with fixed appliances.
- Pregnant women.
- Patients with debilitating systemic diseases.
- Patient who frequently uses analgesics or any drugs that could mask the pain.
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 |
|---|---|---|
| Experimental - Bioactive Restorative SystemFollowing selective caries removal to soft dentin, the cavity will be restored using a bioactive restorative system consisting of a bioactive universal adhesive followed by placement of a bioactive bulk-fill resin composite. | Procedure or surgery | Bioactive Restorative System |
| Active Comparator -Conventional Restorative SystemFollowing selective caries removal to soft dentin, the cavity will be restored using a conventional universal adhesive system followed by placement of a bulk-fill resin composite | Procedure or surgery | Conventional Restorative System |
Primary outcome
Clinical assessment of Pulp sensibility.
Time frame: 24 months
Thermal pulp test
2 secondary outcomes
Clinical assessment of pain.
Time frame: 24 months
Thickness and quality of Dentin bridge formation
Time frame: 24 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 21 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Deep Carious Lesions
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Evaluation of Selective and Stepwise Excavation in Young Permanent Teeth With Deep Caries Lesions.
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Pulp Inflammatory Markers and Outcome of Pulpotomy
Pulpitis in Permanent Teeth, Dental Caries Extending to Pulp
Not yet recruitingPhase 2
A Clinical Study of KH001 for Pulp Preservation and Safety in Deep Dentin Caries
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RecruitingObservational study
The Prognostic Impact of Symptoms and Lesion Depth in Partial Removal of Carious Tissue
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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.
Esraa Hamdy Saber E.H. Assistant lecturer, PhD contact
Questions about this trial
What is this clinical trial studying?
A study testing Experimental - Bioactive Restorative System and Active Comparator -Conventional Restorative System in people with Deep Carious Lesions and Partial Caries Removal, run by Cairo University.
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 10 inclusion and 13 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: opening soon, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Esraa Hamdy Saber E.H. Assistant lecturer, PhD ((+2) 01010200882, esraah.hamdy@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical assessment of Pulp sensibility. (time frame: 24 months). 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 21 Jan 2026.