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
NCT ID: NCT07171775
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
66 participants
INTERVENTIONAL
2026-06-01
2028-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Success Rate of Single Versus Two Visit Regenerative Treatment Protocol in Non Vital Mature Anterior Teeth
NCT03717337
Clinical and Radiographic Outcomes of Partial Pulpotomy Procedure in Primary Molars Utilizing Different Capping Materials and Different Restorative Methods
NCT06227390
Clinical Evaluation of a Simplified-Shade Nano-Hybrid Composite With Full-Coverage Silane Coating and High-Performance Pulverized Fillers
NCT07334509
Evaluation of Conservative Management of Teeth With Deep Cavitated Carious Lesions
NCT06171776
Clinical Performance of Endocrowns Fabricated From Two Hybrid Ceramic Materials on Endodontically Treated Molars: A Randomized Clinical Trial
NCT07005167
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Bioactive Restorative System
Experimental Group (Bioactive Restorative System):
Experimental - Bioactive Restorative System
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.
Conventional Restorative System
Control Group (Conventional Restorative System)
Active Comparator -Conventional Restorative System
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Experimental - Bioactive Restorative System
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 System
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Adult patients (age: 18-40 years) of both genders.
2. Good oral hygiene.
3. Willing to sign the informed consent.
4. Cooperative patients who accept the follow-up period.
Tooth-related criteria:
1. Posterior permanent caries (ICDAS 5-6).
2. Radiographically, caries is extending 50% of dentine with a radiopaque layer between the carious lesion and the pulp chamber.
3. Sensitive teeth according to the cold pulp test.
4. Negative response in percussion test.
Exclusion Criteria
1. Allergy to any of the restorative materials.
2. Patients undergoing orthodontic treatment with fixed appliances.
3. Pregnant women.
4. Patients with debilitating systemic diseases.
5. Patient who frequently uses analgesics or any drugs that could mask the pain.
Tooth-related criteria:
1. Teeth with previous restorations.
2. Spontaneous pain or prolonged pain (more than 15 s) after the sensitivity test (cold test), which would indicate irreversible pulpitis.
3. Negative sensibility tests, periapical radiolucency, and sensitivity to axial or lateral percussion.
4. Mobile teeth, indicating periodontal disease or trauma.
5. External or internal resorption.
6. Chipped teeth or Cuspal loss
18 Years
40 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cairo University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Esraa Hamdy Saber Mohamed
Assistant lecturer
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CU-2025-09
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.