PROMs Comparing Digital & Conventional Workflows

Study Overview
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Brief Summary
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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.

Official Title
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Patient-reported Outcome Measures (PROMs) Comparing Digital and Conventional Workflows for Treatment With Single-unit Implant Restorations: A Randomized Controlled Trial

Conditions
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Dental Implant

Intervention / Treatment
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* Procedure: Treatment of implant single crown


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Digital and conventional workflows for treatment of implant single crowns, and also the material used.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Workflows<br>Digital and conventional workflows for treatment of implant single crowns | Procedure: Treatment of implant single crown<br>* Digital or Conventional Workflows for treatment of implant single crown and materials used.<br>|
| Experimental: Materials<br>Materials for treatment of implant single crowns (polymer-infiltrated ceramic networks, PICNs and lithium disilicate, LS2). | Procedure: Treatment of implant single crown<br>* Digital or Conventional Workflows for treatment of implant single crown and materials used.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported outcome measure (PROM): satisfaction with impression technique via VAS questionnaire | 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). | After impression, At first visit within 30 minutes | 
| Patient reported outcome measure (PROM): satisfaction with final implant restoration via VAS questionnaire | 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). | 1 week after prosthesis delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional implant prosthodontic score (FIPS) | objective evaluation by a dental professional applying the functional implant prosthodontic score (FIPS). | Prosthesis delivery visit, an average of 2 weeks after first visit for impression procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clinical Research, Digital Workflow, Patient-Reported Outcome Measures (PROMs), Crowns, Functional Implant Prosthodontic Score (FIPS), Dental Implant