PROMs Comparing Digital & Conventional Workflows

NCT04986761 | Completed

• 1 other identifier: MU-DT/PY-IRB 2019/DT146
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implant

Keywords

Clinical Research; Dental Implant; Digital Workflow; Patient-Reported Outcome Measures (PROMs); Crowns; Functional Implant Prosthodontic Score (FIPS)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Functional implant prosthodontic score (FIPS)

  Prosthesis delivery visit, an average of 2 weeks after first visit for impression procedure

Study Arms (2)

Workflows

EXPERIMENTAL

Digital and conventional workflows for treatment of implant single crowns

Procedure: Treatment of implant single crown

Materials

EXPERIMENTAL

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

Procedure: Treatment of implant single crown

Interventions

Treatment of implant single crown PROCEDURE

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

Materials; Workflows

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mahidol University: lead
• ITI International Team for Implantology, Switzerland: collaborator

Study Sites (1)

Faculty of dentistry, Mahidol University

Bangkok, 10400, Thailand

Location

Related Publications (1)

• 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.

  PMID: 25864771 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor received only data without participant group assigned after the intervention was done by a investigator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: August 3, 2021
• Study Start: July 1, 2020
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: August 4, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)