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

Tooth Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03234868
• Other study ID #: H2015-4
• Status: Completed
• Phase: Phase 4
• First received: April 13, 2017
• Last updated: July 26, 2017
• Start date: January 1, 2016
• Est. completion date: June 2017

Study information

• Verified date: July 2017
• Source: University Hospital of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Tooth Loss

Intervention

Device:
• Impression procedure
Each patient will go through both type of impression during single appointment: first the digital impression and then the conventional one (to avoid residual impression materials for the optical impressions). The time necessary for each procedure will be recorded.
• Crown manufacturing procedures
Test and control implant crowns will be screw-retained on a multi-unit abutment. The conventional crown will be made of a Zirconia framework veneered with cosmetic ceramics directly screwed on the multi-unit platform (no titanium base). The experimental crown will be made in full zirconia and designed in the TRIOS software.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Liege

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fit of the crowns	To measure this parameter we will focus on interproximal fit and occlusion. Interproximal contact points will be checked with dental floss.	1 year
Secondary	Time consumption at the dental chair	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).	1 year
Secondary	Time consumption in the lab	The time needed by the lab for manufacturing the crowns will be evaluated by timing all the different steps.	1 year
Secondary	Global cost	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.	1 year
Secondary	Esthetical aspect	A VAS evaluation of the esthetic properties (scoring from zero to ten each crown) will be achieved after the placement of each crown.	1 year
Secondary	Patient centered outcomes	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).	1 year