Patients' Satisfaction and Clinical Investigation of Removable Partial Denture Anchorage With Extracoronal Adhesive Attachments in Comparison With Clasp-retained Partial Dentures
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Patients' satisfaction with extracoronal adhesive attachments (group A) compared to conventional clasp-retained prostheses (group B) on a visual analogue scale (VAS)
研究概览
简要总结
Removable partial dentures (RPD) are a well-established treatment option for the prosthetic rehabilitation of partially edentulous patients. They are retained at the remaining natural teeth by clasps to provide functional stability. As an alternative to clasps extacoronal adhesive attachments are fixed to the abutment teeth using adhesive cementation techniques. These adhesive attachments improve retention and stability of the prostheses and are indicated when the patient requires a non-visible retention element and healthy coronal tooth structure is available as a prerequisite. In clinical practice, extracoronal adhesive attachments offer a minimally invasive and aesthetic anchoring alternative of removable dental prostheses associated with higher costs compared to a common clasp retention. As a result, adhesive attachments are relatively rarely used and are technically sensitive both in the clinical realisation and in terms of the dental technology. Hence, limited scientific data are available regarding their long-term clinical behaviour, but no data is available about patients' satisfaction with such extracoronal adhesive attachments.
This research project aims to investigate patients' satisfaction with extracoronal adhesive attachments (group A) of removable dental prostheses in comparison to clasps (group B), and to investigate the short- and long-term clinical performance of both treatment options.
This is a non-interventional observational study. Only routine clinical examinations are performed. No additional risks or burdens arise for participants. All measures fall under minimal risk A according to ClinO, Art. 61. Overall risk: Minimal. No invasive procedures or biological sampling. Ethical and legal standards are fully met.
Sex and gender dimensions are not relevant to the topic of the study as the population is determined by patients treated since 2001 and cannot be influenced by the study design.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Signed informed consent.
- •Patients with at least one extracoronal adhesive attachment for anchoring an RPD and patients with clasp-retained RPD during a 25-year period (2001 - 2025) at the Department for Reconstructive Dentistry or the affiliated student course.
- •The attachment or clasp must have been in place for a minimum of six months at the time of clinical follow-up.
- •Sufficient availability of medical/dental records
- •Age ≥18 years at time of initial treatment.
- •Ability to attend a clinical follow-up appointment.
排除标准
- •Patients unable to provide informed consent.
- •Incomplete or missing documentation of the prosthetic treatment.
- •Attachments or clasps inserted less than six months ago.
- •Inability to attend the follow-up appointment or language barriers preventing study understanding.
结局指标
主要结局
Patients' satisfaction with extracoronal adhesive attachments (group A) compared to conventional clasp-retained prostheses (group B) on a visual analogue scale (VAS)
时间窗: From 2001 to present (RDP with retention element has to be in place for at least 6 months)
The primary objective of this study is to assess patients' satisfaction with extracoronal adhesive attachments (group A) compared to conventional clasp-retained prostheses (group B) on a visual analogue scale (VAS). The scale ranges from 0 - 100. A lower score means a worse outcome (satisfaction low) and a higher score a better outcome (satisfaction high). The participants will be instructed and asked to mark a point on the scale according to their satisfaction with the extracoronal adhesive attachment or the clasp-retained prostheses.
次要结局
- Occurrence of biological complications associated with the use of extracoronal adhesive attachments and conventional clasps(From 2001 to present (RDP with retention element has to be in place for at least 6 months))
- Occurrence of technical complications associated with the use of extracoronal adhesive attachments and conventional clasps(From 2001 to present (RDP with retention element has to be in place for at least 6 months))
研究者
Florence Auderset
Member of Research Group of the Department of Clinical Research, Principal Investigator, Dr. med. dent.
University of Basel