Status:
NOT_YET_RECRUITING
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
Lead Sponsor:
Cairo University
Collaborating Sponsors:
providing support: Equipment and some consumables by Department of Oral Medicine, Periodontology and Oral Diagnosis, Faculty of Dentistry, Cairo University
Conditions:
Dental Caries
Eligibility:
All Genders
22-42 years
Phase:
NA
Brief Summary
a two-year, double-blind, randomized controlled trial evaluates the effectiveness of a bioactive glass adhesive (Hi-Bond Universal) versus a conventional adhesive (OptiBond Universal) in Class II cari...
Detailed Description
This study is a two-year, double-blind, randomized controlled clinical trial designed to compare the clinical performance and radiographic outcomes of a mesoporous bioactive glass adhesive (Hi-Bond Un...
Eligibility Criteria
Inclusion
- Adult patients aged 22 to 42 years.
- 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
- Allergy to any of the restorative materials (OptiBond Universal or Hi-Bond Universal).
- 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.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06990945
Start Date
October 1 2025
End Date
December 1 2027
Last Update
May 25 2025
Active Locations (1)
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1
Faculty of Dentistry, Cairo University
Cairo, Egypt, 11559