Clinical Performance And Radiographic Assessment Of Mesoporous Bioactive Glass Adhesive Vs. Universal Adhesive In Class II Carious Lesions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Clinical Performance - Functional Properties (Retention loss)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
This study employs a double-blinded design to minimize potential biases in outcome assessment and data analysis. The following masking strategy will be implemented:
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.
入排标准
- 年龄范围
- 22 Years 至 42 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Clinical Performance - Functional Properties (Retention loss)
时间窗: 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)
次要结局
- Clinical Performance - Functional Properties (fracture of the material)(24 months (Baseline, 6 months, 12 months, 18 months, 24 months))
- Approximal Anatomical Form(24 months (Baseline, 6 months, 12 months, 18 months, 24 months))
- Marginal Adaptation(24 months (Baseline, 6 months, 12 months, 18 months, 24 months))
- Clinical Performance - Biological Properties (Caries at Restoration Margins)(24 months (Baseline, 6 months, 12 months, 18 months, 24 months))
- Postoperative Hypersensitivity(24 months (Baseline, 6 months, 12 months, 18 months, 24 months))
- Adjacent Mucosa Condition(24 months (Baseline, 6 months, 12 months, 18 months, 24 months))
- Esthetic Properties - Staining (Surface and Margin)(24 months (Baseline, 6 months, 12 months, 18 months, 24 months))
- Remaining Dentin Bridge - Remineralization(24 months (Baseline, 6 months, 12 months, 18 months, 24 months))
研究者
Ahmed Hesham samaha
PhD candidate Conservative Department Cairo University
Cairo University