The Study Aims to Compare the Effectiveness of Mesoporous Bioactive Glass-containing Adhesives vs Conventional Universal Adhesives on the Clinical Performance Composite Restorations Through Promoting Dentin Remineralization After Selective Caries Removal Over a Two-year Follow-up
NCT ID: NCT06990945
Last Updated: 2025-05-25
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
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NOT_YET_RECRUITING
NA
80 participants
INTERVENTIONAL
2025-10-31
2027-12-31
Brief Summary
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Detailed Description
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Eligible participants presenting with ICDAS 5 and 6 carious lesions in posterior permanent teeth will be randomly assigned to one of two treatment groups. The intervention group will receive the Hi-Bond Universal adhesive, a bioactive glass-modified adhesive intended to promote dentin remineralization and reduce postoperative hypersensitivity through calcium and phosphate ion release. The control group will be treated with OptiBond Universal, a conventional adhesive providing mechanical bonding without bioactive properties.
Clinical outcomes will be evaluated using the FDI World Dental Federation criteria, focusing on functional properties such as fracture resistance, marginal adaptation, and retention. Radiographic assessments will quantify dentin remineralization using digital grayscale analysis. Hypersensitivity will be recorded using a patient-reported Likert scale at baseline, 6, 12, 18, and 24 months.
The primary outcome is the functional integrity of the restorative material, assessed at 24 months. Secondary outcomes include the presence of marginal caries, postoperative hypersensitivity, and radiographic evidence of dentin remineralization. Data will be analyzed using appropriate statistical methods to determine differences between the two adhesive systems.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Participant Blinding:
Participants will be unaware of the type of adhesive used during the restorative procedure. Both adhesives (Hi-Bond Universal and OptiBond Universal) will be applied using identical clinical procedures to maintain blinding.
Outcomes Assessor Blinding:
The outcomes assessors (N.S. and R.A.), responsible for evaluating clinical performance (fracture resistance, marginal adaptation, hypersensitivity) and radiographic assessments, will be blinded to the group assignment. They will not have access to information regarding the type of adhesive used for each patient.
Operator (A.H.) Not Blinded:
The operator performing the restorative procedures cannot be blinded due to the nature of the intervention. The operator will be aware of the adhesive used but will not participate in the outcome assessments.
Study Groups
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Optibond Universal adhesive
Participants in the control group will receive a conventional universal adhesive (OptiBond Universal) applied after selective caries removal. The adhesive will be applied according to the manufacturer's instructions, followed by placement of a nano-hybrid composite (Optishade Universal Kerr Dental).
OptiBond Universal Adhesive
conventional universal adhesive designed for bonding composite restorations to enamel and dentin.
The adhesive will be applied after selective caries removal following a standardized protocol:
Selective enamel etching with 37% phosphoric acid for 15 seconds.
Application of OptiBond Universal adhesive with agitation for 20 seconds.
Light curing for 20 seconds using a LED curing device.
Incremental application of a nano-hybrid composite (Optishade Universal Kerr Dental, USA).
Occlusal adjustment, finishing, and polishing.
Intervention - Hi-Bond Universal Adhesive
Participants in this group will receive a bioactive glass-modified adhesive, Hi-Bond Universal (Mediclus, Korea). This adhesive releases calcium and phosphate ions to enhance dentin remineralization and reduce hypersensitivity, applied after selective caries removal and followed by composite restoration.
Hi-Bond Universal Adhesive
A bioactive glass adhesive containing mesoporous bioactive glass designed to promote dentin remineralization, manufactured by Mediclus, Korea. It releases calcium and phosphate ions to enhance dentin sealing and reduce hypersensitivity
The adhesive will be applied after selective caries removal following a standardized protocol:
Selective enamel etching with 37% phosphoric acid for 15 seconds.
Application of HI Bond Universal adhesive with agitation for 20 seconds.
Light curing for 20 seconds using a LED curing device.
Incremental application of a nano-hybrid composite (Optishade Universal Kerr Dental, USA).
Occlusal adjustment, finishing, and polishing.
Interventions
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Hi-Bond Universal Adhesive
A bioactive glass adhesive containing mesoporous bioactive glass designed to promote dentin remineralization, manufactured by Mediclus, Korea. It releases calcium and phosphate ions to enhance dentin sealing and reduce hypersensitivity
The adhesive will be applied after selective caries removal following a standardized protocol:
Selective enamel etching with 37% phosphoric acid for 15 seconds.
Application of HI Bond Universal adhesive with agitation for 20 seconds.
Light curing for 20 seconds using a LED curing device.
Incremental application of a nano-hybrid composite (Optishade Universal Kerr Dental, USA).
Occlusal adjustment, finishing, and polishing.
OptiBond Universal Adhesive
conventional universal adhesive designed for bonding composite restorations to enamel and dentin.
The adhesive will be applied after selective caries removal following a standardized protocol:
Selective enamel etching with 37% phosphoric acid for 15 seconds.
Application of OptiBond Universal adhesive with agitation for 20 seconds.
Light curing for 20 seconds using a LED curing device.
Incremental application of a nano-hybrid composite (Optishade Universal Kerr Dental, USA).
Occlusal adjustment, finishing, and polishing.
Eligibility Criteria
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Inclusion Criteria
Presence of Class II carious lesions in posterior permanent teeth (ICDAS 5 \& 6).
Radiographic evidence of caries extending to 50% of dentin with a radiopaque layer between the lesion and pulp chamber.
Teeth with normal pulp vitality confirmed through cold pulp sensibility test.
Teeth with no periapical pathosis on radiographic examination.
Good oral hygiene as determined by the attending clinician.
Willingness to sign the informed consent and comply with the 2-year follow-up protocol.
Cooperative patients who can attend all follow-up visits.
Exclusion Criteria
Patients currently undergoing orthodontic treatment with fixed appliances.
Pregnant women or those planning pregnancy during the study period.
Patients with systemic diseases that could interfere with dental treatment (e.g., uncontrolled diabetes, cardiovascular diseases).
Use of analgesics or medications that could mask postoperative sensitivity.
Teeth with previous restorations or treatment in the target area.
Teeth exhibiting spontaneous pain or lingering pain after sensitivity testing, indicating irreversible pulpitis.
Negative response in cold pulp sensibility test, indicating pulp necrosis.
Teeth with periapical radiolucencies or signs of infection.
Mobile teeth due to periodontal disease or trauma.
Teeth with extensive structural damage, such as cusp fractures or deep cracks.
Patients unable to comply with the follow-up schedule.
22 Years
42 Years
ALL
No
Sponsors
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providing support: Equipment and some consumables by Department of Oral Medicine, Periodontology and Oral Diagnosis, Faculty of Dentistry, Cairo University
UNKNOWN
Cairo University
OTHER
Responsible Party
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Ahmed Hesham samaha
PhD candidate Conservative Department Cairo University
Locations
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Faculty of Dentistry, Cairo University
Cairo, , Egypt
Countries
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Central Contacts
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Ahmed Hesham Samaha, PhD candidate Conservative Dep
Role: CONTACT
Prof. Dr. Rasha Raafat Main Supervisor / Data Monitoring, professor conservative depar.
Role: CONTACT
Other Identifiers
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cu-fund-202505
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CU-2025-05
Identifier Type: -
Identifier Source: org_study_id
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