Customized Impressions in Dental Implants - Soft Tissues Changes

NCT03496428 | Completed Results

• 1 other identifier: II2017-06
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Soft Tissue

Keywords

intra-oral scanner; customized impression coping; extra-oral scanner; accuracy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Discrepancy (Trueness) Between STL Files in Teeth Adjacent to Implant

  Both techniques will be used in the same appointment upon 3 months use of provisional crown

Study Arms (1)

Dental implant Impression Techniques

OTHER

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

Interventions

Dental implant impressions- Different Techniques DEVICE

Assessment of soft tissues changes with different techniques

Dental implant Impression Techniques

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Implantology Institute: lead
• Grupo de Investigação em Bioquímica e Biologia Oral: collaborator

Study Sites (1)

Instituto de Implantologia

Lisbon, 1070-064, Portugal

Location

Results Point of Contact

• Title: Prof. Dr. Duarte Marques
• Organization: Implantology Institute

d.marques@institutoimplantologia.com

+351217 210 980

Study Officials

• Duarte Marques, DDS, PhD

  Implantology Institute

  PRINCIPAL INVESTIGATOR

• João Caramês, DDS, PhD

  Implantology Institute

  STUDY DIRECTOR

• Antonio Mata, DDS, PhD

  Grupo de Investigação em Bioquímica e Biologia Oral

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Altough it is a single arm two different techniques will be used and obtained STL files will be identified as A and B and the outcomes assessor will not be informed which group corresponds to intra-oral scanner and extra-oral scanner
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: To describe the soft tissues dimensional changes (based on STL files) occurred between an intra-oral scanner and standartized scan-body and a extra-oral scanner of stone cast poured from silicone impression with a customized impression coping 12 months after implant placement and simultaneous regeneration with L-PRF and bovine bone graft in the aesthetic zone of atrophic maxillae in full arch implant supported rehabilitations

Study Record Dates

• First Submitted: March 31, 2018
• First Posted: April 12, 2018
• Study Start: June 2, 2017
• Primary Completion: August 25, 2018
• Study Completion: September 1, 2018
• Last Updated: October 30, 2019
• Results First Posted: October 30, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)