Metal-reinforced Flexible Poly-amide Complete Denture Versus Heat-cured Poly-methyl Methacrylate in Terms of Oral Health Related Quality of Life; Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 18
- 主要终点
- oral health related quality of life
研究概览
简要总结
Polymethyl methacrylate have been used since 1937 as a gold standard for a denture base material because of its several advantages as; good esthetics, adequate strength, easy repair and simple processing techniques. As any material it has some problems as polymerization shrinkage, low impact and flexural properties and low fatigue resistance2. So polyamide was introduced into dentistry to be used as a denture base material in order to solve these problems. Polyamide denture base materials have some superior properties than PMMA as; High impact & flexural strength, excellent esthetics and less release of residual monomers4. Although being an advantage from the point of patient satisfaction, flexural property considered to be a contraindication for a denture base material.
The invistigators' trial is done in order to improve rigidity of a polyamide material as well as to improve oral health related quality of life in comparison to heat cured polymethyl methacrylate.
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
- 45 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •i. Male or female patient with age range (45-55) and in good medical condition ii. All patients have skeletal Angle's class I maxillo-mandibular relationship and have sufficient inter-arch distance.
- •iii. Free from any systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles.
- •iv. Free from any tempro-mandibular joint disorder. v. The patients have good oral hygiene.
排除标准
- •i. Patients having hormonal disorders as diabetes, thyroid or parathyroid hormonal diseases were not included.
- •ii. Patient with xerostomia or excessive salivation. iii. Patient with abnormal tongue behavior and/or size. iv. No intraoral soft and hard tissue pathosis
研究组 & 干预措施
poly-amide
poly-amide is a thermoplastic material recently introduced to be used as a complete denture material, that provide excellent aesthetics and flexibility.
干预措施: poly-amide (Other)
poly-methyl methacrylate
poly-methyl methacrylate has been commonly used as a material for constructing complete dentures and proved to have high success rate and considered to be gold standard.
干预措施: poly-methyl methacrylate (Other)
结局指标
主要结局
oral health related quality of life
时间窗: one month
OHIP-49 questionnaire
次要结局
未报告次要终点
研究者
Amr Magdy Ibrahim
Internal resident at removable prosthodontic department
Cairo University