PROMs Comparing Digital & Conventional Workflows

Sponsor

Mahidol University (Other)

Overall Status

Completed

CT.gov ID

NCT04986761

Collaborator

ITI International Team for Implantology, Switzerland (Other)

Enrollment

Location

Arms

Actual Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Implant	Procedure: Treatment of implant single crown	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Digital and conventional workflows for treatment of implant single crowns, and also the material used.Digital and conventional workflows for treatment of implant single crowns, and also the material used.

Masking:

Single (Outcomes Assessor)

Masking Description:

Outcomes Assessor received only data without participant group assigned after the intervention was done by a investigator

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 1, 2020

Actual Primary Completion Date :

Mar 31, 2021

Actual Study Completion Date :

Mar 31, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Patient reported outcome measure (PROM): satisfaction with impression technique via VAS questionnaire [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).
Patient reported outcome measure (PROM): satisfaction with final implant restoration via VAS questionnaire [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).

Secondary Outcome Measures

Functional implant prosthodontic score (FIPS) [Prosthesis delivery visit, an average of 2 weeks after first visit for impression procedure]
objective evaluation by a dental professional applying the functional implant prosthodontic score (FIPS).

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.