Patient-reported Outcome Measures (PROMs) Comparing Digital and Conventional Workflows for Treatment With Single-unit Implant Restorations: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Patient reported outcome measure (PROM): satisfaction with final implant restoration via VAS questionnaire
研究概览
简要总结
This randomized controlled trial (RCT) analyzed monolithic single-unit implant restorations out of lithium disilicate (LS2) or polymer-infiltrated ceramic networks (PICN) in a chairside digital workflow (Test) and a conventional protocol (Control). The primary outcome was subjective patient perception in terms of PROMs comparing digital and conventional impression techniques as well as patients' satisfaction related to the final implant restoration among difference workflows and materials. The secondary outcome was to investigate the objective evaluation by a dental professional applying the functional implant prosthodontic score (FIPS). The null-hypothesis of this RCT was that both workflows and the two materials for the monolithic implant restorations had comparable results with respect to the defined outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes Assessor received only data without participant group assigned after the intervention was done by a investigator
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The participants are in the age of more than 20 years old and not more than 80 years old.
- •The participants who have a transmucosal implant system (Straumann TL RN/WN, Institut Straumann, AG, Basel, Switzerland) placed in single-tooth gap in the area of premolar or molar regions in the maxilla and mandible with existing interproximal and antagonist contacts.
- •The participants' general medical health is healthy or has a well-controlled systemic disease.
- •The participants' general oral health has shown no sign of infection or unsuccessfully treated diseases such as chronic periodontitis.
排除标准
- •The participants who are smoking more than 10 cigarettes per day.
- •The participants with pregnancy.
- •The participants with a psychiatric disorder
- •The participants with a history of radiation therapy at the head and neck area.
- •The participants with a history of chemotherapy.
- •The participants with bony pathologies such as osseous dysplasia, odontogenic cyst or tumor, etc.
结局指标
主要结局
Patient reported outcome measure (PROM): satisfaction with final implant restoration via VAS questionnaire
时间窗: 1 week after prosthesis delivery
Patients were requested to score their feeling on screw-retained monolithic implant crowns in a 10cm VAS one week after delivery of the final implant crowns. The level of patients' satisfaction was measured in four categories: (1) perception of the overall treatment outcome (0=unsatisfactory to 10=excellent); (2) opinion on the function of the restoration (0=unsatisfactory to 10=excellent); (3) esthetic perspective (0=unsatisfactory to 10=excellent), and (4) ease of oral hygiene care (0=unsatisfactory to 10=excellent).
Patient reported outcome measure (PROM): satisfaction with impression technique via VAS questionnaire
时间窗: After impression, At first visit within 30 minutes
After impression-taking, questionnaires were handed out to the participants to evaluate PROMs via visual analog scales (VAS). Six categories were assessed: (1) overall treatment time of impression-taking procedure (0=unsatisfactory to 10=excellent); (2) convenience level of the impression technique (0=unsatisfactory to 10=excellent); (3) anxiety level of impression technique (0=low to 10=high); (4) bad taste and (5) nausea caused by the impression (each 0=no sensation to 10=a lot of sensation); and (6) pain during impression-taking procedure (0=no pain to 10=a lot of pain).
次要结局
- Functional implant prosthodontic score (FIPS)(Prosthesis delivery visit, an average of 2 weeks after first visit for impression procedure)