Customized Impressions in Dental Implants - Soft Tissues Changes

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).

Study Overview

• Status: Completed
• Conditions: Soft Tissue
• Intervention / Treatment: Device: Dental implant impressions- Different Techniques

Detailed Description

"Custom-guided" tissue healing with o provisional restoration is the most predictable way to achieve natural anatomically shaped tissue and optimal esthetics. Several authors describe the use of an anatomically contoured provisional restoration to start to guide the soft tissue healing in an ideal, natural morphology that replicates the tooth form. Being that, after shaping the tissue to ideal anatomic form and health the exact duplication of the soft tissue contour should be obtained so that laboratory can duplicate it in the final restoration. Nowadays gold-standard, describes the use of a customized impression coping that replicates the provisional soft tissue contour by the use of and analog-silicone index upon which a gypsum cast is created.

The use of computer-aided design/computer-assisted manufacture (CAD/CAM) technologies to manufacture prosthetic frameworks on dental implants is noticeably increasing. This method requires the use of an STL file which can be acquired intra-orally or extraorally using a stone cast poured from a conventional implant impression using a customized implant impression coping.

Several studies have already described the accuracy of STL data and that evaluating STL models can be done by best fit algorithms in appropriate softwares.

In this pilot study, the investigators aim to evaluate soft tissue profile changes in single unit implants in the aesthetic area using a customized impression coping with conventional methods and the intraoral impression with an intraoral scanner (Trios, 3Shape). Additionally position discrepancies of adjacent teeth between the two techniques will be assessed.

This pilot study will include 6 patients with single unit implant which will be recruited according inclusion criteria and submitted to the two different impression techniques. Conventional stone cast will be scanned with a laboratory scanner D2000 (3Shape) with a described deviation of 5μm. Two STL files will be obtained per patient and by established methods with a reverse engineering software (Geomagic Control X, 3D Systems) discrepancies between them assessed.

Differences in axis (x, y, z) and overall distances will be assessed in the soft tissues (18 points) and in adjacent teeth (26 points) according established methods, per patient. Additionally, 3D colored maps will be produced to ascertain volumetric changes between techniques. T-test and Wilcoxon signed-rank test will be used and the level of statistical significance set at P<0.05. Sample size determination will be performed based on obtained results.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Lisboa, Portugal, 1070-064
    • Instituto de Implantologia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with single implant with adjacent teeth in the anterior esthetic area (Pre-Molar to Pre-Molar) of the upper arch with provisional implant crown use and indication for rehabilitation for definitive implant supported crown.

Exclusion Criteria:

- Patients without soft tissue contouring or without provisional implant supported use

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Dental implant Impression Techniques; Dental implant impressions- Different Techniques An customized impression coping will be created based on the provisional crown emergence profile which will be used to perform a silicone implant impression. A conventional cast will be created based on the silicone impression and an extra-oral scanner reading will be performed with a 3shape D2000. An intra-oral scanner (Trios, 3Shape) will be used to scan the entire arch. The STL file created will be compared and tooth positions and soft tissues discrepancies will be determined

Device: Dental implant impressions- Different Techniques; Assessment of soft tissues changes with different techniques

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Soft Tissues Around Implant	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.	Both techniques will be used in the same appointment upon 3 months use of provisional crown

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Discrepancy (Trueness) Between STL Files in Teeth Adjacent to Implant	Linear measurements in µm between STL files in teeth adjacent to implant in several pre-defined locations	Both techniques will be used in the same appointment upon 3 months use of provisional crown

Collaborators and Investigators

• Sponsor: Implantology Institute
• Collaborators: Grupo de Investigação em Bioquímica e Biologia Oral
• Investigators: Principal Investigator: Antonio Mata, DDS, PhD, Grupo de Investigação em Bioquímica e Biologia Oral

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2017
• Primary Completion (Actual): August 25, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: March 31, 2018
• First Submitted That Met QC Criteria: April 5, 2018
• First Posted (Actual): April 12, 2018

Study Record Updates

• Last Update Posted (Actual): October 30, 2019
• Last Update Submitted That Met QC Criteria: October 29, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: accuracy; extra-oral scanner; intra-oral scanner; customized impression coping
• Other Study ID Numbers: II2017-06

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