Comparative Study of Silicone-based Soft Liner Versus Versacryl Liner for Mandibular Complete Denture Cases(Randomized Clinical Trial)
试验速览
- 阶段
- 不适用
- 入组人数
- 28
- 主要终点
- oral health related quality of life
研究概览
简要总结
Resilient liners were introduced in the1950s and have been used since then as a gold standard material to increase the tolerance, retention and comfort of complete dentures. Due to drawbacks of conventional resilient liners, their longevity is questionable and they require replacement which is time consuming and costly for the dentist and patient respectively. Versacryl is a biocompatible intraoral thermo-elastic material. So versatile, it can be used to improve esthetics, retention and comfort for the patient. It softens with heat and when it is inserted to patient's mouth, it cools to body temperature providing desired rigidity. This process can be repeated many times to ensuring the comfort for the patient. Versacryl has a reported predictable long term performance, durable bonding to acrylic denture bases, high fatigue endurance, excellent wear characteristics and solvent resistance with almost no free monomer in the processed material .
The investigators' trial is done in order to improve the longevity and oral health related quality of life of soft liners in comparison to silicone-based soft liners.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completely edentulous patients wearing complete dentures.
- •Flat mandibular residual ridge.
- •Mandibular denture indicated for relining.
- •Patients with minimum of 2 years and maximum of 5 years complete denture usage.
- •Angle's class I maxillary-mandibular relationship
排除标准
- •Drug or alcohol abuse.
- •Inflammatory changes in the oral cavity.
- •Candidiasis.
- •Any intra-oral soft tissue hyperplasia.
- •Physical reasons that could affect follow-up.
- •Psychiatric problems.
- •Heavy smokers.
- •Dentures indicated for remake.
研究组 & 干预措施
Versacyl soft liner
Versacryl soft liner are flexible biocompatible materials with a reported predictable long term performance, durable bonding to acrylic denture bases, high fatigue endurance, excellent wear characteristics and solvent resistance with almost no free monomer in the processed material
干预措施: Versacryl soft liner (Other)
Silicone-based soft liner
Resilient liners were introduced in the1950s and have been used since then as a gold standard material to increase the tolerance, retention and comfort of complete dentures. Resilient liners also known as 'soft liners' can be classified as temporary or permanent, cold-cured or heat-cured.Resilient liners can be divided into two main types: plasticized acrylic resins and silicone elastomers.
干预措施: Silicone-based soft liner (Other)
结局指标
主要结局
oral health related quality of life
时间窗: 4 months
OHIP-49 questionnaire
次要结局
- tissue keratinization(4 months)
研究者
Mennatallah Mohamed Moustafa
Internal resident at removable prosthodontic department
Cairo University