PROMs Comparing Digital & Conventional Workflows

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2021-03-31

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.

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Detailed Description

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Conditions

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Dental Implant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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

Study Groups

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Workflows

Digital and conventional workflows for treatment of implant single crowns

Group Type EXPERIMENTAL

Treatment of implant single crown

Intervention Type PROCEDURE

Digital or Conventional Workflows for treatment of implant single crown and materials used.

Materials

Materials for treatment of implant single crowns (polymer-infiltrated ceramic networks, PICNs and lithium disilicate, LS2).

Group Type EXPERIMENTAL

Treatment of implant single crown

Intervention Type PROCEDURE

Digital or Conventional Workflows for treatment of implant single crown and materials used.

Interventions

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Treatment of implant single crown

Digital or Conventional Workflows for treatment of implant single crown and materials used.

Intervention Type PROCEDURE

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.

Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes