Development and Evaluation of a Patient-reported Experience Measure (PREM) in Implant Dentistry: an Exploratory Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 99
- 主要终点
- Patient reported experience at Pre-Treatment, Baseline (Implant Insertion) and Up to 6 months (Final Prosthesis Delivery)
研究概览
简要总结
The study will gather data on patient reported experience (PREM) before, during and after dental implant treatment. Patients scheduled in three treatment groups for either single tooth, multiple teeth or full-arch dental rehabilitation are included in the study and will be treated according standard of care. Additionally, they are asked to report their experience based on pre-defined questionnaire assessing patient acceptance of implant treatment in dentistry. Patients will be followed-up until 1-Year post Final Prosthesis Delivery.
This studies primary endpoint is the completion of the PREM questionnaires. The study is not intended to investigate safety and performance of the used medical devices.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject signed informed consent
- •Subject is at least 18 years old at the time of treatment
- •Subject presented with the need of dental implant treatment for single tooth, multiple teeth, or full-arch rehabilitation
- •Subject with medical and anatomical conditions that are in accordance with the applicable instructions for use (IFU)
- •Subject agree to provide information on her/his experience and outcomes before, during and after the treatment
- •Subject has a working e-mail address
- •Subject has sufficient English language skills for answering the PREM questionnaires
排除标准
- •Anatomical conditions discovered during surgery preventing the use of intended implant system
- •Subject with history of allergy or adverse reactions to any materials used
- •Uncontrolled unstable systemic disease
- •Any ongoing application of medication that is interfering with the dental treatment
- •Subject is not willing / unable to complete the PREM questionnaires
- •Subject that is planning not to return to the investigational site for follow-up visits within study schedule
- •Pregnant or lactating women at the time of implant insertion
结局指标
主要结局
Patient reported experience at Pre-Treatment, Baseline (Implant Insertion) and Up to 6 months (Final Prosthesis Delivery)
时间窗: Pre-Treatment, Baseline (Implant Insertion), Up to 6 months (Final Prosthesis Delivery)
次要结局
- Patient reported experience at 1-Year Follow-up(1-Year Follow-Up)
- OHIP-14 (summary score and separate questions)(Pre-Treatment, Baseline (Implant Insertion), Up to 6 months (Final Prosthesis Delivery), 1-Year Follow-Up)
- Patient satisfaction with esthetics and function (VAS)(Pre-Treatment, Baseline (Implant Insertion), Up to 6 months (Final Prosthesis Delivery), 1-Year Follow-Up)
- Implant survival(Up to 6 months (Final Prosthesis Delivery), 1-Year Follow-Up)
- Prosthetic survival(1-Year Follow-Up Visit)
- Keratinized Mucosa Status(Up to 6 months (Final Prosthesis Delivery), 1-Year Follow-Up)
- Gingival Index(Up to 6 months (Final Prosthesis Delivery), 1-Year Follow-Up)
研究者
Dr Robert Bowe
BA, BDentSc, MFD RCSI
Bowe Dental Clinic