Clinical Outcomes of Bonded Monolithic Translucent Zirconia Crowns Using Two Different Compositions of Self-adhesive Resin Cements (Randomized Clinical Trial)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Marginal discoloration
研究概览
简要总结
The aim of the present study is to evaluate the clinical outcomes (marginal discoloration, marginal adaptation, gingival health, debonding and patient satisfaction) of translucent zirconia crowns bonded by TheraCem (MDP, calcium and fluoride releasing) self-adhesive resin cement compared to multilink self-adhesive resin cement.
详细描述
Clinical outcomes of bonded monolithic translucent zirconia crowns using two different compositions of self-adhesive resin cements (Randomized Clinical Trial)
Research question:
Will TheraCem self-adhesive resin cement (MDP, calcium and fluoride releasing cement) give better outcomes when bonding monolithic translucent zirconia crowns to tooth structure compared to Multilink self-adhesive resin cement (non MDP, non-calcium and fluoride releasing cement) in terms of marginal discoloration, marginal adaptation, gingival health, debonding and patient satisfaction?
PICOS:
P: Population: Patients requiring single zirconia crowns I: Intervention: TheraCem self-adhesive resin cement (MDP, calcium and fluoride releasing cement) C: Comparison: Multilink adhesive resin cement (non MDP, non-calcium and fluoride releasing cement)
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
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All subjects are required to be:
- •From 18-50 years old, be able to read and sign the informed consent document.
- •Have no active periodontal or pulpal diseases, have teeth with good restorations
- •Psychologically and physically able to withstand conventional dental procedures
- •Patients with teeth problems indicated for single crowns:
- •Badly decayed teeth
- •Teeth restored with large filling restorations
- •Endodontically treated teeth
- •Malformed teeth
- •Malposed teeth (Tilted, over-erupted, rotated, etc.)
- •Spacing between teeth
- •Able to return for follow-up examinations and evaluation.
排除标准
- •Patient less than 18 or more than 50 years
- •Patient with active resistant periodontal disease
- •Patients with poor oral hygiene and uncooperative patients
- •Pregnant women
- •Patients in the growth stage with partially erupted teeth
- •Psychiatric problems or unrealistic expectations
结局指标
主要结局
Marginal discoloration
时间窗: 9 months
Alpha (A): no discoloration (There is no visual evidence of marginal discoloration different from the color of the restorative material and from the color of the adjacement. (visual inspection) Bravo (B): discoloration without axial penetration (There is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration, but the discoloration has not penetrated along the restoration in a pulpal direction. (visual inspection) Charlie (C): discoloration with axial penetration (There is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration that has penetrated along the restoration in a pulpal direction. (visual inspection
次要结局
- Marginal Adaptation(9 months)
- Patient satisfaction(9 months)
研究者
Diana Mostafa Habeb
Assistant Lecturer of Fixed Prosthodontics
Cairo University