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
- Conditions
- Dental Caries
- Registration Number
- NCT06990945
- Lead Sponsor
- Cairo University
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Clinical Performance - Functional Properties (Retention loss) 24 months (Baseline, 6 months, 12 months, 18 months, 24 months) The clinical performance of the adhesive systems will be assessed based on the functional properties, specifically focusing on the retention of the composite Restoration Clinical assessment of the condition of adjacent mucosa to detect signs of irritation or inflammation caused by the adhesive materials.
Assessment Method: FDI Criteria Scores (1-5)
- Secondary Outcome Measures
Name Time Method Remaining Dentin Bridge - Remineralization 24 months (Baseline, 6 months, 12 months, 18 months, 24 months) Evaluation of remineralization at the remaining dentin bridge using digital radiography and grayscale analysis.
Assessment Method: Digital Radiography (Grayscale values 0-255)Clinical Performance - Functional Properties (fracture of the material) 24 months (Baseline, 6 months, 12 months, 18 months, 24 months) Assessment of fracture resistance of the restorative materials (Hi-Bond Universal vs. OptiBond Universal) using the FDI Criteria. This includes the evaluation of material integrity, chipping, fractures, and overall structural durability of the restorations.Clinical assessment of the condition of adjacent mucosa to detect signs of irritation or inflammation caused by the adhesive materials.
Assessment Method: FDI Criteria Scores (1-5)Approximal Anatomical Form 24 months (Baseline, 6 months, 12 months, 18 months, 24 months) Assessment of contact points and contours of the restoration, focusing on anatomical integrity and function.
Assessment Method: FDI Criteria Scores (1-5)Marginal Adaptation 24 months (Baseline, 6 months, 12 months, 18 months, 24 months) Evaluation of the marginal adaptation of the adhesive systems using clinical criteria. This outcome assesses the adhesive's ability to seal restoration margins effectively.Clinical assessment of the condition of adjacent mucosa to detect signs of irritation or inflammation caused by the adhesive materials.
Assessment Method: FDI Criteria Scores (1-5)Clinical Performance - Biological Properties (Caries at Restoration Margins) 24 months (Baseline, 6 months, 12 months, 18 months, 24 months) The presence of caries at restoration margins will be assessed using clinical examinations. The objective is to evaluate the adhesive's ability to prevent secondary caries development at the margins of the restorations.Clinical assessment of the condition of adjacent mucosa to detect signs of irritation or inflammation caused by the adhesive materials.
Assessment Method: FDI Criteria Scores (1-5)Postoperative Hypersensitivity 24 months (Baseline, 6 months, 12 months, 18 months, 24 months) Assessment of patient-reported tooth hypersensitivity following adhesive application and composite restoration.Clinical assessment of the condition of adjacent mucosa to detect signs of irritation or inflammation caused by the adhesive materials.
Assessment Method: FDI Criteria Scores (1-5)Adjacent Mucosa Condition 24 months (Baseline, 6 months, 12 months, 18 months, 24 months) Clinical assessment of the condition of adjacent mucosa to detect signs of irritation or inflammation caused by the adhesive materials.
Assessment Method: FDI Criteria Scores (1-5)Esthetic Properties - Staining (Surface and Margin) 24 months (Baseline, 6 months, 12 months, 18 months, 24 months) Clinical evaluation of staining at the surface and margins of the restoration to assess esthetic integrity.
Assessment Method: FDI Criteria Scores (1-5)
Trial Locations
- Locations (1)
Faculty of Dentistry, Cairo University
🇪🇬Cairo, Egypt