NCT03496428

Customized Impressions in Dental Implants - Soft Tissues Changes

Completed NA Results posted Last updated 30 October 2019

What this trial tests

NA trial testing Dental implant impressions- Different Techniques in Soft Tissue in 6 participants. Completed in 1 September 2018.

Timeline

2 June 2017

Primary endpoint
25 August 2018

1 September 2018

Quick facts

Lead sponsor	Implantology Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	screening
Enrollment	6
Start date	2 June 2017
Primary completion	25 August 2018
Estimated completion	1 September 2018
Sites	1 location across Portugal

Drugs / interventions tested

• Dental implant impressions- Different Techniques

Conditions studied

• Soft Tissue — all drugs for Soft Tissue →

Sponsor

Implantology Institute

Who can join

18 and older, any sex, with Soft Tissue. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Changes in Soft Tissues Around Implant Primary · Both techniques will be used in the same appointment upon 3 months use of provisional crown

Discrepancies in soft tissues around implants between different techniques, conventional and digital, in a single unit implant impression, measured as root mean square in µm.

Group	Value	95% CI
Dental Implant Impression Techniques	243.89	209.15 – 278.63

Discrepancy (Trueness) Between STL Files in Teeth Adjacent to Implant Secondary · Both techniques will be used in the same appointment upon 3 months use of provisional crown

Linear measurements in µm between STL files in teeth adjacent to implant in several pre-defined locations

Group	Value	95% CI
Dental Implant Impression Techniques	51.08	45.68 – 56.47

Sponsor's own description

Six patients with a single unit implant in the anterior maxilla (from premolar to premolar), after at least 3 months with provisional implant supported restoration will be submitted to definitive implant impressions.

Informed consents and local ethical committee clearance will be obtained. Patients will be submitted to a silicon impression with a customized impression coping from which a conventional cast will be obtained and scanned with D2000 (3Shape) and to an intraoral scan with Trios (3Shape). Standard Tessellation Language (STL) files will be obtained from both procedures and imported to reverse engineering software Geomagic Control X (3D Systems) and the distance between both scans will be calculated in a colored 3D map. From this map, two outcomes will be analyzed: the changes in soft tissues around implants with the two techniques (primary outcome) and the discrepancy between both scans in the teeth adjacent to the implants (secondary outcome).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.