Digital vs Conventional Impression in Capturing the Emergence Profile Around Maxillary Anterior Implant-supported Crowns
NCT ID: NCT06425770
Last Updated: 2024-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
15 participants
INTERVENTIONAL
2023-10-05
2026-02-01
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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conventional cast
conventional impression with elastomer (silicon), from which a high-precision epoxi-resin cast with gingival mask will be created
conventional impresion and cast
conventional impression with elastomer (silicon), from which a high-precision epoxi-resin cast with gingival mask will be created
indirect digital impression and 3D printed cast
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
indirect digital impression and 3D printed cast
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
direct digital impression
the emergence profile will be directly scanned with intraoral scanner at 0, 2, 10, and 20 minutes after removing the provisional restoration
direct digital impression
the emergence profile will be directly scanned with intraoral scanner at 0, 2, 10, and 20 minutes after removing the provisional restoration
Interventions
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indirect digital impression and 3D printed cast
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
direct digital impression
the emergence profile will be directly scanned with intraoral scanner at 0, 2, 10, and 20 minutes after removing the provisional restoration
conventional impresion and cast
conventional impression with elastomer (silicon), from which a high-precision epoxi-resin cast with gingival mask will be created
Eligibility Criteria
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Inclusion Criteria
* 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
* Peri-implant inflammation
18 Years
ALL
Yes
Sponsors
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Semmelweis University
OTHER
Responsible Party
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Principal Investigators
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Krisztina Mikulás, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Prosthodontics, Semmelweis University
Locations
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Semmelweis University, Department of Prosthodontics
Budapest, Pest County, Hungary
Countries
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Central Contacts
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Facility Contacts
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References
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Li J, Chen Z, Wang M, Wang HL, Yu H. Dynamic changes of peri-implant soft tissue after interim restoration removal during a digital intraoral scan. J Prosthet Dent. 2019 Sep;122(3):288-294. doi: 10.1016/j.prosdent.2018.07.020. Epub 2019 Mar 15.
Xiong J, Sun W, Huang B, Ji W, Shi B. Effect of the implant-supported provisional restoration on the accuracy of digital peri-implant mucosa replication-A clinical study. Clin Oral Implants Res. 2022 Jun;33(6):598-606. doi: 10.1111/clr.13921. Epub 2022 Mar 26.
Monaco C, Scheda L, Baldissara P, Zucchelli G. Implant Digital Impression in the Esthetic Area. J Prosthodont. 2019 Jun;28(5):536-540. doi: 10.1111/jopr.12991. Epub 2018 Dec 3.
Other Identifiers
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129/2023
Identifier Type: -
Identifier Source: org_study_id
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