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Treatment Time Comparing Digital & Conventional Workflows

NCT ID: NCT05165563

Last Updated: 2021-12-21

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

2021-10-26

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 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.

Detailed Description

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Conditions

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Dental Implant

Keywords

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Clinical Research Dental Implant Digital Workflow Crowns Treatment time

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

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 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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Align Technology, Inc.

INDUSTRY

Sponsor Role collaborator

Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Faculty of dentistry, Mahidol University

Bangkok, , Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type BACKGROUND
PMID: 26394340 (View on PubMed)

Other Identifiers

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MU-DT/PY-IRB 2020/DT010

Identifier Type: -

Identifier Source: org_study_id