Benefit of the Digital Workflow for Screw-retained Single Implant Restorations

Phase 4

Completed

• Conditions: Tooth Loss

• Registration Number: NCT03234868
• Lead Sponsor: University of Liege

Brief Summary

The aim of this research project is emphasize the benefit of the digital workflow compared to conventional impressions and crown processing with standard la procedures. The objectives of the present study are to measure and compare the global cost, the time spent in the dental chair and in the lab and the fit of both digital and conventional workflow. Additionally, patient centered outcomes will be recorded.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Study First Submitted: 2017-04-13
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2017-07
• Study First Submitted QC: 2017-07-26
• Last Update Submitted: 2017-07-26
• Study First Posted: 2017-07-31
• Last Update Posted: 2017-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Subject must have voluntarily signed the informed consent form before any study related action
• Age: 18 with one or more missing teeth in the maxillary area, seeking for implant therapy.
• Men/Women
• In good systemic health (ASA I/ II)
• Present with no contra indication against oral surgical interventions
• Patients required replacement of a single missing tooth. The tooth at the implant site(s) must have been extracted or lost at least 12 weeks before the date of implantation.
• At least 10 mm of bone in the vertical dimension
• At least 6 mm of bone in the bucco-lingual dimension.
• No need for bone augmentation procedure in any of the dimensions
• Full mouth plaque score (FMPI) lower or equal than 25%

Exclusion Criteria

• Autoimmune disease require medical treatment
• Medical conditions requiring prolonged use of steroids
• Use of Bisphosphonate intravenously or more then
• Infection (local or systemic) - patient with gingivitis or active local infection will undergo a medical treatment prior to his entrance to the study, each individual will be evaluated prior to study procedure for suitability, in case of systemic infection the evaluation will be based on medical anamneses, and if necessary will be referred to relevant medical tests.
• Current pregnancy or breastfeeding women
• Alcoholism or chronically drug abuse
• Immunocompromised patients
• Uncontrolled Diabetes
• Smokers
• Prisoners

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fit of the crowns	1 year	To measure this parameter we will focus on interproximal fit and occlusion. Interproximal contact points will be checked with dental floss.

Secondary Outcome Measures

Name	Time	Method
Global cost	1 year	Considering the time spent by the dentist and the lab technician, the cost of the optical impression system, of impression materials, of impression trays, of scan bodies and of impression copings, the final cost of each crown will be compared.
Esthetical aspect	1 year	A VAS evaluation of the esthetic properties (scoring from zero to ten each crown) will be achieved after the placement of each crown.
Patient centered outcomes	1 year	A questionnaire based on VAS scales will be given out and filled by the patients. Thus it will be possible to estimate which of both impressions is less unpleasant for them (questionnaire are in developement).
Time consumption at the dental chair	1 year	Numbers of appointment needed for each procedure will be counted and each one of them will be timed (from the unscrewing of the healing abutment until its replacement).
Time consumption in the lab	1 year	The time needed by the lab for manufacturing the crowns will be evaluated by timing all the different steps.