Treatment Time Comparing Digital & Conventional Workflows

NCT05165563 | Completed

• 1 other identifier: MU-DT/PY-IRB 2020/DT010
• 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 to investigate the treatment time of the overall operation. The null hypothesis of this RCT was that both workflows had comparable results with respect to the defined outcomes.

Conditions

Dental Implant

Keywords

Clinical Research; Dental Implant; Digital Workflow; Crowns; Treatment time

Outcome Measures

Primary Outcomes (1)

• Treatment time

  Treatment time in every steps were recorded.

  First visit to prosthesis delivery visit, through study completion, an average of 1 month

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: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participants having a transmucosal implant system (Straumann TL RN/WN, Institut Straumann, AG, Basel, Switzerland) were placed in a single-tooth gap in the area of premolar or molar regions in the maxilla and mandible with existing interproximal and antagonist contacts.
• general medical health is healthy or has a well-controlled systemic disease.
• general oral health has shown no sign of infection or unsuccessfully treated diseases such as chronic periodontitis.

You may not qualify if:

• smoking more than 10 cigarettes per day.
• pregnancy.
• psychiatric disorder
• history of radiation therapy at the head and neck area.
• history of chemotherapy.
• history of bony pathologies such as osseous dysplasia, odontogenic cyst or tumor, etc.

Sponsors & Collaborators

• Mahidol University: lead
• Align Technology, Inc.: collaborator

Study Sites (1)

Faculty of dentistry, Mahidol University

Bangkok, 10400, Thailand

Location

Related Publications (1)

• Joda T, Bragger U. Time-Efficiency Analysis Comparing Digital and Conventional Workflows for Implant Crowns: A Prospective Clinical Crossover Trial. Int J Oral Maxillofac Implants. 2015 Sep-Oct;30(5):1047-53. doi: 10.11607/jomi.3963.

  PMID: 26394340 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• 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: November 22, 2021
• First Posted: December 21, 2021
• Study Start: July 1, 2020
• Primary Completion: October 26, 2021
• Study Completion: October 26, 2021
• Last Updated: December 21, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)