NCT07043998招募中不适用
Evaluation of Full Veneered Porcelain-Fused-to-Metal Crowns Cemented With Self-Adhesive Resin Cement Using Two Curing Modes: A Randomized Clinical Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Retention of PFM crowns
研究概览
简要总结
P - Population/Patient Problem Adult patients requiring full coverage porcelain-fused-to-metal (PFM) crown restorations I - Intervention PFM crowns veneered with porcelain system cemented using self-adhesive resin cement in DUAL-CURED mode (light-cured for 20 seconds per surface) C - Comparison PFM crowns veneered with porcelain system cemented using self-adhesive resin cement in SELF-CURED mode (no light curing, 5 minutes self-cure) O - Outcome(s)
- Primary: Retention of PFM crowns (Modified USPHS criteria)
- Secondary: Marginal adaptation, recurrent caries, marginal discoloration (Modified USPHS criteria) T - Time 18-month follow-up period with evaluations at baseline, 6, 12, and 18 months
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)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients requiring full coverage PFM crown restorations
- •Age ≥ 21 years
- •Vital or endodontically treated teeth
- •Sufficient tooth structure for crown retention
- •Willing and able to provide written informed consent
- •Ability to attend all follow-up appointments
- •Adequate oral hygiene as determined by the investigator
排除标准
- •Patients with active periodontal disease (probing depth > 4mm, bleeding on probing)
- •Patients with severe parafunctional habits (e.g., bruxism confirmed by clinical examination)
- •Poor oral hygiene (plaque index > 30%)
- •Pregnancy or nursing
- •Systemic diseases affecting treatment outcomes (e.g., uncontrolled diabetes, immunosuppression)
- •Known allergies to study materials (metal alloys, porcelain, or resin cement components)
- •Inability to comply with study requirements
- •Current participation in other dental clinical trials
- •Active orthodontic treatment
研究组 & 干预措施
Adult patients requiring PFM crown cemented with dual cured self adhesive resin cement
Active Comparator
干预措施: Self-adhesive resin cement in DUAL-CURED mode (Other)
Adult patients requiring PFM crown cemented with self cured self adhesive resin cement
Active Comparator
干预措施: Self-adhesive resin cement in SELF-CURED mode (Other)
结局指标
主要结局
Retention of PFM crowns
时间窗: 18 months
Modified USPHS criteria (Scores)
次要结局
- Marginal adaptation(18 months)
- Recurrent caries(18 months)
- Marginal discoloration(18 months)
研究者
Omnia Nabil
Associate Professor
Cairo University
研究点 (1)
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