PROMs in Implant Dentistry: Development of a Dental Implant Standard Set
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Patient-reported outcomes measures
研究概览
简要总结
Rationale Over the past decades, the placement of dental implants and prosthetic rehabilitation has revolutionised dentistry overwhelmingly. It is generally regarded as a safe and reliable method due to the high predictability and survival rates. Survival of suprastructure and implant, health status of the peri-implant tissues and radiographic peri-implant marginal bone loss are commonly used criteria to assess the implant treatment outcome. Although this way of treatment evaluation is important to develop and deliver safe dental implants, it does not provide sufficient information for the development of value-based healthcare.
With this new approach of health outcome measurement, in which patient reported outcomes and clinical outcomes are combined, new definitions of success are created that transform dental implant health care by informed decision making, quality improvement and reducing costs. If dentists and oral surgeons make treatment decisions based on this comprehensive health outcome, patients are more likely to receive high quality care and payers only pay for services that achieve results. Therefore, the development of an implant dentistry specific question set, a Dental Implant Standard Set, capturing both the clinicians' and patients' perspective of implant-related health outcomes is of utmost clinical relevance.
Objective(s) A combination of patient-reported outcomes and clinical health outcomes in a Dental Implant Standard Set enables clinicians to evaluate care delivery and to compare performance in a comprehensive and meaningful way. Therefore, the main aim for this project is to implement a workable Dental Implant Standard Set for the dental implant professional to monitor and improve clinicians and patients' perception of peri-implant health following dental implant treatment, and to monitor and improve the performance of dental implant practice as a whole.
Study type This is a prospectively designed multicenter cohort study including 30 dental practices in the Netherlands and Spain
Study population A total of 1000 consecutive patients will be included by the participating dental practices within 12 months.
Questionnaires regarding the clinical outcomes are administered to the dentists providing the dental implant care. PROMs are administered to the participating patients.
Generally, patients aged 18-70 years that have an indication for implant supported fixed single or multiple tooth replacement or implant-supported removable prosthesis are eligible to participate.
Methods the questionnaires are administered to the participating dentist (for clinical outcomes) and patients (Patient Reported Outcome Measures (PROMs) in combination with the collection of clinical and case mix variables at 6 time points: before and at implant placement, at prosthesis placement and 10-12 months after implant placement. The PROMs is administered via a Questionnaire Manager (QM), that is developed by an external company. Within the QM also case mix and clinical data are registered
Burden and risks No risks are involved throughout the study The concise questionnaires to the patients and participating dentist will be a limited burden to the standard dental implant care.
Recruitment and consent Treating clinicians will recruit participants for this project. Clinicians will provide the patient with a brief overview of the study. Participants will receive a digital questionnaire via a link with an informed consent form and contact details (of the principal investigator) for remaining questions.
Data is not open accessible and patient specific data will be anonymously stored.
详细描述
Background and Rationale:
Dental implant treatment success has traditionally been evaluated using clinical parameters such as implant survival, marginal bone loss, and tissue health from the clinician perspective. However, the shift toward value-based healthcare requires integration of patient-reported outcome measures (PROMs) to capture treatment value from the patient's perspective.
The recently published Implant Dentistry Core Outcome Set and Measurement (ID-COSM) international consensus established essential domains for implant research but lacks a validated, clinically feasible patient-reported outcome instrument. Existing dental PROMs like The Oral Health Impact Profile with 14 items are too general for implant-specific evaluation, while comprehensive tools like the ICHOM Adult Oral Health Standard Set are too lengthy for routine clinical use.
Study Design:
This prospective multicenter cohort study develops and validates the Dental Implant Set (DENS), a patient-reported outcome measure based on ID-COSM domains and items extracted from validated instruments (The Oral Health Impact Profile with 14 items, the Psychosocial Impact of Dental Aesthetics Questionnaire, the Patient Satisfaction Questionnaire with 18 items, the Dental Satisfaction Questionnaire, and the Quality of My Facial Questionnaire are used). The DENS captures four core domains: pathophysiology, implant/prosthesis lifespan, life impact, and functional outcomes.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years
- •Indication for implant-supported fixed single or multiple tooth replacement
- •Indication for implant-supported removable prosthesis
- •Immediate implant placement cases
- •Implant placement after implant failure
排除标准
- •Inadequate oral hygiene
- •Physical inability
- •Pregnancy
- •History of radiotherapy in head and neck region
- •Language barriers
- •Patients requiring soft tissue grafts prior to dental implant placement
- •Patients requiring bone augmentation with harvesting autogenous bone from intraoral sites prior to dental implant placement
结局指标
主要结局
Patient-reported outcomes measures
时间窗: Follow up from baseline (pre-implantation), 1-2 weeks post-implantation (surgical healing), 3 months post-implantation (tissue maturation), 3 months post-loading (initial functional adaptation), and 10 months post-loading
1\. Feasibility of DENS Implementation Measure: Completion rate percentage across all timepoints Time Frame: Baseline, 1-2 weeks post-implantation, 3 months post-implantation, 3 months post-loading, 10 months post-loading Description: Percentage of enrolled patients completing DENS questionnaire at each timepoint. Target ≥80% completion rate for clinical implementability.
Internal Consistency Reliability
时间窗: Follow up from baseline (pre-implantation), 1-2 weeks post-implantation (surgical healing), 3 months post-implantation (tissue maturation), 3 months post-loading (initial functional adaptation), and 10 months post-loading
Measure: Cronbach's alpha coefficient for DENS domains Time Frame: At study completion (10 months post-loading) Description: Internal consistency reliability based on ID-COSM domains. Target α ≥0.7 for acceptable reliability.
次要结局
- Secondary outcome measures(Follow up from baseline (pre-implantation), 1-2 weeks post-implantation (surgical healing), 3 months post-implantation (tissue maturation), 3 months post-loading (initial functional adaptation), and 10 months post-loading)
- Responsiveness to Treatment Phases Measure: Effect sizes (Cohen's d) for DENS domain changes(Time Frame: Follow up from baseline (pre-implantation), 1-2 weeks post-implantation (surgical healing), 3 months post-implantation (tissue maturation), 3 months post-loading (initial functional adaptation), and 10 months post-loading)
- Convergent Validity Assessment Measure: Correlations between DENS domains and clinical parameters(Time Frame: Follow up from baseline (pre-implantation), 1-2 weeks post-implantation (surgical healing), 3 months post-implantation (tissue maturation), 3 months post-loading (initial functional adaptation), and 10 months post-loading)
研究者
Dr. Justin Pijpe
Principal Investigator, Oral Maxillofacial Surgery Department
Erasmus Medical Center