Effect of Abutment Configuration on Peri-implant Soft and Hard Tissue in the Esthetic Zone - Randomized Clinical Trial
NCT ID: NCT06407271
Last Updated: 2024-05-09
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
30 participants
INTERVENTIONAL
2023-12-13
2028-12-30
Brief Summary
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Detailed Description
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In the maxilla, in the aesthetic zone, in patients with a thick phenotype, for a crown anchored with a solo immediate implant:
I.A To investigate hard and soft tissue volume changes around custom CAD/CAM (computer-aided design and manufacturing) vs. cylindrical zirconiom-dioxide (ZrO2) healing abutments 4 months after their fixation for immediate implant placement.
I.B To measure the thickness of keratinized mucosa by ultrasound I.C Monitoring microcirculation in wound healing by laser speckle contrast imaging (LSCI) and ultrasound.
II. Custom zirconia abutment (on Ti-base) retained, screw-retained all-ceramic solo restorations:
* Evaluation of hard and soft tissue volume changes
* Esthetic evaluation (Pink and White Aesthetic Scores (PES, WES)), FIPS (functional implant prosthodontic score), pain, follow-up of biological and technical complications at 1 and 3 years.
ARMS:
A. immediate implantation + cylindrical healing abutment + CAD/CAM screw-retained (on Ti-base), full-countour monolithic zirconium-dioxide restoration
B. immediate implantation + custom healing abutment + CAD/CAM screw-retained (on Ti-base), custom ZrO2 abutment retained all-ceramic restoration with hand-built-up supramucosal veneering
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CAD/CAM custom ZrO2 healing abutment
Application of custom, zirconium-dioxide healing abutment, fabricated with computer aided design and manufacturing, following immediate implantation.
CAD/CAM custom ZrO2 healing abutment
Application of custom, zirconium-dioxide healing abutment, fabricated with computer aided design and manufacturing, following immediate implantation.
Cylindrical ZrO2 healing abutment
Application of cylindrical, zirconium-dioxide healing abutment following immediate implantation.
Cylindrical ZrO2 healing abutment
Application of cylindrical, zirconium-dioxide healing abutment following immediate implantation.
Interventions
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CAD/CAM custom ZrO2 healing abutment
Application of custom, zirconium-dioxide healing abutment, fabricated with computer aided design and manufacturing, following immediate implantation.
Cylindrical ZrO2 healing abutment
Application of cylindrical, zirconium-dioxide healing abutment following immediate implantation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* good general health
* good oral hygiene (FMPS \< 25%)
* healthy periodontium (PPD \< 4mm)
* thick phenotype
* maxilla anterior region (extended to 15-25 positions)
* solo missing teeth, intact adjacent teeth
* type 1 alveolar shape after extraction 1
* retained occlusion
* baseline buccal bone wall thickness at least 1.5 mm, based on intact CBCT scan
* patient voluntarily accepts and signs the information and consent form for the study
Exclusion Criteria
* general surgical or oral surgery contraindication
* a patient who has undergone local radiotherapy
* active periodontal inflammation, inflammation of the alveolar cavity
* smoking
* posterior region
* pregnancy, lactation
* psychological or mental involvement affecting individual plaque control
* presence of an implant adjacent to the planned implant
* inadequate oral hygiene
* need for vertical bone augmentation
* gingival recession
* Inappropriate implant position for screw fixation
* bruxism
18 Years
ALL
Yes
Sponsors
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Institut Straumann AG
INDUSTRY
Semmelweis University
OTHER
Responsible Party
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Principal Investigators
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Krisztina Mikulás, PhD
Role: PRINCIPAL_INVESTIGATOR
Semmelweis University, Department of Prosthodontics
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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Péter Tajti
Role: CONTACT
Facility Contacts
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Other Identifiers
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260/2023
Identifier Type: -
Identifier Source: org_study_id
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