Semmelweis University, Department of Prosthodontics
Budapest, Pest County, 1088, Hungary
Location status: Recruiting
NCT Number: NCT06407271
The aims of our study are to investigate in patients with immediate implantation replacing a single tooth in the maxillary anterior (#FDI 15-25) region the effect of (a) custom vs cylindrical stock healing abutments, then (b) screw retained single ceramic crowns, on the peri implant hard- and soft-tissue formation and blood flow.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Budapest, Pest County, 1088, Hungary
Location status: Recruiting
AIMS:
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:
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Application of custom, zirconium-dioxide healing abutment, fabricated with computer aided design and manufacturing, following immediate implantation.
Other names: CAD-CAM custom zirconium-dioxide healing abutment
Application of cylindrical, zirconium-dioxide healing abutment following immediate implantation.
Other names: Cylindrical zirconium-dioxide healing abutment
Time frame: 4, 12, 36 months post op.
Volume changes in midfacial mucosa [mm]
Time frame: 4, 12, 36 months post op.
Keratinized mucosa width [mm]
Time frame: before implantation, 4,12, 36 months post op.
Keratinized mucosa thickness with ultrasound [mm]
Time frame: 4, 12, 36 months post op.
Follow-up of 2D linear and 3D volumetric changes in soft tissue using intraoral scanner
Time frame: at 0-7., 0., 1., 4., 7., 14. day, and 1., 2., 4., 6., 12 month after implantation
blood flow measurement with laser speckle contrast imaging
Time frame: at 0-7., 0., 1., 4., 7., 14. day, and 1., 2., 4., 6., 12 month after implantation
blood flow measurement with ultrasound
Time frame: 4, 12, 36 months post op.
marginal bone loss
Time frame: 4, 12, 36 months
Number of survived implants out of total implants placed
Time frame: 0., 1., 7., 14. day, and 1., 2., 4., 6., 12., 36. month after implantation
% of sites with dental plaque over total measures sites
Time frame: 0. day, and 4., 12., 36. month after implantation
% of sites with bleeding over total measures sites
Time frame: 0., 4., 12., 36. month after implantation
Probing pocket depth
Time frame: 4 months after implantation, at final restoration delivery
Functional implant prosthodontic score
Time frame: 4 months after implantation, at final restoration delivery
Pain numerical rating scale
Contact information is provided by the study sponsor or research team.
Semmelweis University
Other
Effect of Abutment 3-dimensional Configuration on Peri-implant Soft and Hard Tissue in the Esthetic Zone - Randomized Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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