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Digital vs Conventional Impression in Capturing the Emergence Profile Around Maxillary Anterior Implant-supported Crowns

S

Semmelweis University

Status

Enrolling

Conditions

Dental Implants, Single-Tooth
Dental Impression Technique

Treatments

Procedure: direct digital impression
Procedure: indirect digital impression and 3D printed cast
Procedure: conventional impresion and cast

Study type

Interventional

Funder types

Other

Identifiers

NCT06425770
129/2023

Details and patient eligibility

About

This study compares conventional impression and cast fabrication to direct/indirect digital scannig and 3D printed casts regarding their accuracy in replicating the peri-implant emergence profile of single implants in the maxillary anterior region (FDI #15-25).

Full description

Correct design of the peri-implant emergence profile (EP) is crucial for maintaining the health of the supracrestal complex and long-term success of the implant implant-prosthodontics. After its formation with a provisional restoration, its shape needs to be transferred to the final restoration via conventional elastomeric or digital (direct/indirect) impression taking.

Our aims are to investigate around maxillary anterior single implants in patients with thick gingival phenotype:

  1. the accuracy of direct digital impression vs indirect digital impression vs conventional elastomeric impression in capturing the EP and implant position
  2. the accuracy of 3D printed cast with conventional gingival mask vs conventional epoxy-resin cast with gingival mask in replicating the EP and implant position
  3. the amount of soft tissue collapse at 0,2,10,20 minutes following the removal of the provisional restoration in case of direct EP scanning

Enrollment

15 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Adult above 18 yo
  • No systematic deseases
  • Good oral hygene (FMPS < 25%)
  • Stable occlusion
  • Thick phenotype
  • Single missing maxilary anterior (FDI #15-25 position) tooth replaced with osseointegrated bone level impant
  • Correctly formed soft tissue with CAD/CAM temporary abutment for min. 3 months
  • Neighbouring teeth in place and in good condition
  • Patient voluntarily accepts and signs the patient leaflets for the trial

Exclusion criteria

  • Active periodontitis
  • Peri-implant inflammation

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

15 participants in 3 patient groups

conventional cast
Active Comparator group
Description:
conventional impression with elastomer (silicon), from which a high-precision epoxi-resin cast with gingival mask will be created
Treatment:
Procedure: conventional impresion and cast
indirect digital impression and 3D printed cast
Experimental group
Description:
the provisional restoration will be scanned with intraoral scanner extraorally, based on which a virtual model will be created, from which a 3D printed cast will be created with manually fabricated gingival mask based on the provisional restoration
Treatment:
Procedure: indirect digital impression and 3D printed cast
direct digital impression
Experimental group
Description:
the emergence profile will be directly scanned with intraoral scanner at 0, 2, 10, and 20 minutes after removing the provisional restoration
Treatment:
Procedure: direct digital impression

Trial contacts and locations

1

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Central trial contact

Krisztina Mikulás, PhD; Xinyi Qian

Data sourced from clinicaltrials.gov

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