Evaluation of Candida Albicans Growth on Bre.Flex Versus PEEK ( Polyether Ether Ketone ) Denture Base in Bilateral Maxillary Bounded Partial Denture (Randomized Clinical Trial)
试验速览
- 阶段
- 不适用
- 入组人数
- 18
- 主要终点
- Candida Albicans growth
研究概览
简要总结
This study evaluate Candida Albicans growth on Bre-Flex versus PEEK denture base in Bilateral Maxillary bounded partial denture , half of patients will receive a framework with breflex denture base and the other half will receive a framework with PEEK denture base then evaluate the Candida growth
详细描述
Peek and Bre.flex are both new material that introduced to the market recently with great benefits like aesthetics and bio-compatibility but which material has less candida growth ? Bre.flex is a nylon-based thermoplastic material, composed of nylon polyamide 12 (polyamide).Nylon exhibits high physical strength, heat resistance and chemical resistance. It can be easily modified to increase stiffness and wear resistance. Nylon resin can be semi-translucent and provides excellent esthetics but it is a little more difficult to adjust and polish.
Despite of its highly esthetics features, Nylon still suffers from surface roughness that increase the colonization for candida but less than heat cured acrylic Recently, PEEK is introduced as a removable prosthesis material due to its high mechanical and biological properties but further clinical studies or systematic reviews focusing on the use of PEEK dentures are needed.
The patient will be treated in visits designated as follows:
Visit 1: Preoperative records, clinical, radiographic examination (panoramic and periapical x-rays for evaluation the crown-root ratio, the apical condition of the abutment and their alveolar bone support of abutment) and primary impression will be performed with irreversible hydro-colloid impression material (alginate), The impressions will be poured with type IV dental stone to obtain diagnostic casts.
Visit 2: Maxillary Face-bow will be recorded. The diagnostic casts will be mounted on semi adjustable articulator in centric occluding relation to evaluate the inter arch distance and occlusal plane.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients must have Kennedy class III modification I upper partially edentulous ridges.
- •The remaining teeth have good periodontal condition, with no signs of attrition or gingival recession.
- •Male or female patient with age range (30-55) and in good medical condition
- •All patients have skeletal Angle's class I maxillo-mandibular relationship and have sufficient interarch distance.
- •Free from any systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles.
- •Free from any tempo-mandibular joint disorder.
- •The patients have good oral hygiene and low caries index.
排除标准
- •Patients having abnormal habits as bruxism or clenching
- •Patients having hormonal disorders as diabetes, thyroid or parathyroid hormonal diseases were not included.
- •Teeth with compromised bone support.
- •Patient with xerostomia or excessive salivation.
- •Patient with abnormal tongue behavior and/or size.
研究组 & 干预措施
Group 1
patients will receive partial denture constructed from PEEK material
干预措施: PEEK (Other)
Group 2
patients will receive partial denture constructed from breflex material
干预措施: Bre-Flex (Other)
结局指标
主要结局
Candida Albicans growth
时间窗: one month
after insertion of the denture we will measure the Candida count using Light Microscope and record the CFU/ML (colony-forming units per milliliter) unit
次要结局
未报告次要终点
研究者
Ahmed Sammy Mansour
Principal Investigator
Cairo University