Clinical trial NCT06990945: 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
Official title: Clinical Performance And Radiographic Assessment Of Mesoporous Bioactive Glass Adhesive Vs. Universal Adhesive In Class II Carious Lesions
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dental Caries
Keywords: Class II Carious Lesions
Dentin Remineralization
Dental Adhesives
Bioactive Glass
Restorative Dentistry
Hypersensitivity
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: providing support: Equipment and some consumables by Department of Oral Medicine, Periodontology and Oral Diagnosis, Faculty of Dentistry, Cairo University
First posted: 2025-05-25
Enrollment: 80
Sex: ALL
Minimum age (years): 22
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the study is a 2-year, double-blind, randomized controlled trial with two parallel arms. Participants with Class II carious lesions will be randomly assigned to receive either a mesoporous bioactive glass adhesive (Hi-Bond Universal) or a conventional universal adhesive (OptiBond Universal). Clinical and radiographic assessments will be conducted at baseline, 6 months, 12 months, 18 months, and 24 months to evaluate the adhesive's performance in terms of fracture resistance, retention, marginal adaptation, dentin remineralization, and hypersensitivity.
Primary purpose: TREATMENT

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 carious lesions. The study will assess clinical outcomes such as fracture resistance and marginal adaptation and radiographic evidence of dentin remineralization in 80 adult participants. Hypersensitivity and secondary caries development will also be monitored at multiple time points to determine comparative efficacy.

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 Universal) with a conventional universal adhesive (OptiBond Universal) in Class II carious lesions. The trial will enroll 80 participants aged 22 to 42 years, recruited from the Outpatient Clinic of the Conservative Dentistry Department at Cairo University.

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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Clinical Performance - Functional Properties (Retention loss)
timeFrame: 24 months (Baseline, 6 months, 12 months, 18 months, 24 months)
Secondary outcomes:
measure: Clinical Performance - Functional Properties (fracture of the material)
timeFrame: 24 months (Baseline, 6 months, 12 months, 18 months, 24 months)
measure: Approximal Anatomical Form
timeFrame: 24 months (Baseline, 6 months, 12 months, 18 months, 24 months)
measure: Marginal Adaptation
timeFrame: 24 months (Baseline, 6 months, 12 months, 18 months, 24 months)
measure: Clinical Performance - Biological Properties (Caries at Restoration Margins)
timeFrame: 24 months (Baseline, 6 months, 12 months, 18 months, 24 months)
measure: Postoperative Hypersensitivity
timeFrame: 24 months (Baseline, 6 months, 12 months, 18 months, 24 months)
measure: Adjacent Mucosa Condition
timeFrame: 24 months (Baseline, 6 months, 12 months, 18 months, 24 months)
measure: Esthetic Properties - Staining (Surface and Margin)
timeFrame: 24 months (Baseline, 6 months, 12 months, 18 months, 24 months)
measure: Remaining Dentin Bridge - Remineralization
timeFrame: 24 months (Baseline, 6 months, 12 months, 18 months, 24 months)
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University
Study officials:
References: