PROMs Comparing Digital & Conventional Workflows

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

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.

Study Overview

• Status: Completed
• Conditions: Dental Implant
• Intervention / Treatment: Procedure: Treatment of implant single crown

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Faculty of Dentistry, Mahidol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mahidol University
• Collaborators: ITI International Team for Implantology, Switzerland

Publications and helpful links

General Publications

• Joda T, Bragger U. Patient-centered outcomes comparing digital and conventional implant impression procedures: a randomized crossover trial. Clin Oral Implants Res. 2016 Dec;27(12):e185-e189. doi: 10.1111/clr.12600. Epub 2015 Apr 12.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: July 1, 2021
• First Submitted That Met QC Criteria: July 22, 2021
• First Posted (Actual): August 3, 2021

Study Record Updates

• Last Update Posted (Actual): August 4, 2021
• Last Update Submitted That Met QC Criteria: August 2, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Dental Implant; Clinical Research; Patient-Reported Outcome Measures (PROMs); Crowns; Digital Workflow; Functional Implant Prosthodontic Score (FIPS)
• Other Study ID Numbers: MU-DT/PY-IRB 2019/DT146

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No