Assessment of Microbial Adherence and Patients' Satisfaction in Conventional and Digital 3D Printed Complete Removable Dentures: A Cross Over Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Assessment of oral microorganism proliferation by talking swab from
研究概览
简要总结
The study is a crossover, randomised, controlled clinical trial that will compare and evaluate patients' satisfaction and oral microbiota proliferation in two groups. Group I: Conventionally manufactured CRD Group II: 3D-printed (three-dimensionally printed) CAD/CAM (computer-aided design/computer-aided manufacturing) manufactured CRD, The participants will be selected according to inclusion and exclusion criteria and will be randomly allocated into both groups and then shuffled to the other group using the Research Randomizer Program.
详细描述
The study will be performed at the outpatient clinic of the Oral and Maxillofacial Prosthodontics Department, Faculty of Dentistry, Ain Shams University. Eleven edentulous male patients will be selected and recruited for this clinical trial after the informed consent provided by Faculty of Dentistry Ain Shams University-Research Ethics Committee (FDASU-REC) is assigned. They will be rehabilitated with Conventional and 3D-printed CAD-CAM (computer-aided design/computer-aided manufacturing) CRD. Participants will be randomly assigned to receive either Conventional or 3D-Printed CAD/CAM-manufactured CRD for three months before crossing over to the other set. care provider , investigator and participants will be blinded to the group allocation. Outcomes will be evaluated, including patient satisfaction with dentures and oral microbial adherence. The outcomes will be measured at baseline and at 1 and 3 months. The obtained data will be recorded, tabulated, and statistically analyzed using the appropriate tests for comparison between each group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
neither the patients nor the operator know which type of denture will be inserted
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Patients who have been completely edentulous in both jaws (maxilla and mandible) for at least a year and require treatment with complete dentures.
- •The age of patients ranges from 45 to 60 years old.
- •Patients with a Class I maxillo-mandibular relationship.
- •Patients with adequate inter-arch space.
- •Patients with good neuromuscular control.
- •Patients without any temporomandibular joint disorder.
排除标准
- •Patients with any oral diseases that may affect complete denture construction.
- •Patients with bad oral hygiene.
- •Patients with oral parafunctional habits.
- •Hysterical patients.
- •Patients will undergo or have previously received chemotherapy or radiotherapy.
- •Smokers or drug- addicted patients
结局指标
主要结局
Assessment of oral microorganism proliferation by talking swab from
时间窗: 3 months
Assessment of oral microorganism proliferation by talking swab from the internal surface of both types of CRD to asses the affinity of oral microorganisms.
次要结局
- Evaluation of patients' satisfaction with both types of the Complete Removable Dentures(3 months)
研究者
Omnia M Refai
Lecturer of Oral and Maxillofacial Prosthodontics
Ain Shams University