Treatment Time Comparing Digital & Conventional Workflows

December 6, 2021 updated by: Mahidol University

Comparison of Treatment Time Between Digital and Conventional Workflows for Treatment With Posterior Implant Restorations

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • faculty of dentistry, Mahidol university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment time
Time Frame: First visit to prosthesis delivery visit, through study completion, an average of 1 month
Treatment time in every steps were recorded.
First visit to prosthesis delivery visit, through study completion, an average of 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Collaborators

Align Technology, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Actual)

October 26, 2021

Study Completion (Actual)

October 26, 2021

Study Registration Dates

First Submitted

November 22, 2021

First Submitted That Met QC Criteria

December 6, 2021

First Posted (Actual)

December 21, 2021

Study Record Updates

Last Update Posted (Actual)

December 21, 2021

Last Update Submitted That Met QC Criteria

December 6, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MU-DT/PY-IRB 2020/DT010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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