Clinical and Radiographic Evaluation of The Effect of Acetal Resin Versus PEEK on Supporting Structure of Abutment Teeth in Mandibular Kennedy Class I Partial Dentures Manufactured by CAD-CAM Technology
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pocket Depth
研究概览
简要总结
This study was conducted to evaluate and compare the effect of acetal resin versus Polyether ether ketone (PEEK) partial dentures on abutment teeth supporting structures in Kennedy class I mandibular partial denture cases. Clinical assessments were conducted by assessing the pocket depth (PD), plaque index (PI), and gingival index (GI). Cone beam computed tomography (CBCT) was used to assess abutment alveolar bone height change.
详细描述
This study was a parallel, two-group, double-blinded, randomized clinical trial. The proposal and consents were approved by the Research Ethics Committee. (REC) approval (P-PD-14-14). The Helsinki Declaration's guiding principles were followed when conducting the study. The Comprehensive Standards of Reporting Trials Statement (CONSORT) checklist's structure is followed in the study's presentation. The study was carried out at the Outpatient Clinic of the Removable Prosthodontic Department within the Faculty of Dental Medicine for Girls at Al-Azhar University.
In this study, fifty patients were initially evaluated. After conducting clinical and radiographic assessments, twenty patients who satisfied the inclusion criteria were selected in accordance with the sample size calculation. Each patient received an explanation of every procedure, and informed consent was obtained. These twenty individuals were subsequently divided randomly into two distinct groups (ten in each):
Group I: Ten patients received polyoxymethylene (acetal resin) partial dentures designed and fabricated using CAD/CAM technology. Group II: Ten patients received polyether ether ketone (PEEK) partial dentures designed and fabricated using CAD/CAM technology.
All patients were evaluated clinically and radiographically. Clinical assessments were conducted by assessing the pocket depth (PD), plaque index (PI), and gingival index (GI) at denture insertion, three months later and six months later. Cone beam computed tomography (CBCT) was used to assess abutment alveolar bone height change at the time of denture placement, after three months, and after six months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
(patients and assessors)
入排标准
- 年龄范围
- 40 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Every subject should be free of any systemic diseases that might influence the results of the research.
- •Patient's residual ridges should be covered with healthy mucosa.
- •Their salivary flow and viscosity for all within normal limits.
- •The patients are cooperative and ready to be called back as necessary.
- •had a Class I Angle's ridge relation
排除标准
- •Alcoholic or smokers' patients.
- •Patients with xerostomia or excessive salivation.
- •Patients with parafunctional habits.
- •Patients with ulcerated or inflamed mucosa.
研究组 & 干预措施
Acetal resin partial dentures
ten patients received acetal resin partial dentures designed and fabricated using CAD/CAM technology
干预措施: Acetal resin (Biological)
PEEK partial dentures
ten patients received polyether ether ketone (PEEK) partial dentures designed and fabricated using CAD/CAM technology.
干预措施: Acetal resin (Biological)
结局指标
主要结局
Pocket Depth
时间窗: 6 months
assessing the pocket depth (PD) of abutment teeth
次要结局
- Plaque index(6 months)
- Gingival index(6 months)
- Abutment alveolar bone height change.(6 months)
研究者
Yasmin Seif Eldeen Zidan
Yasmin S. Zidan
Al-Azhar University