PROMs Comparing Digital & Conventional Workflows

Mahidol University

Status: Completed

Conditions: Dental Implant

Treatments: Procedure: Treatment of implant single crown

Study type: Interventional

Funder types: Other

Identifiers

NCT04986761

MU-DT/PY-IRB 2019/DT146

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 25+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Workflows

Experimental group

Description:

Digital and conventional workflows for treatment of implant single crowns

Treatment:

Procedure: Treatment of implant single crown

Materials

Experimental group

Description:

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

Treatment:

Procedure: Treatment of implant single crown