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.
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: * 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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Application of custom, zirconium-dioxide healing abutment, fabricated with computer aided design and manufacturing, following immediate implantation.
Application of cylindrical, zirconium-dioxide healing abutment following immediate implantation.
Semmelweis University, Department of Prosthodontics
Budapest, Pest County, Hungary
RECRUITINGmidfacial keratinized mucosa volume
Volume changes in midfacial mucosa \[mm\]
Time frame: 4, 12, 36 months post op.
midfacial keratinized mucosa width
Keratinized mucosa width \[mm\]
Time frame: 4, 12, 36 months post op.
Keratinized mucosa thickness
Keratinized mucosa thickness with ultrasound \[mm\]
Time frame: before implantation, 4,12, 36 months post op.
soft tissue volume
Follow-up of 2D linear and 3D volumetric changes in soft tissue using intraoral scanner
Time frame: 4, 12, 36 months post op.
laser speckle contrast imaging (LSCI)
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
ultrasound
blood flow measurement with ultrasound
Time frame: at 0-7., 0., 1., 4., 7., 14. day, and 1., 2., 4., 6., 12 month after implantation
marginal bone loss
marginal bone loss
Time frame: 4, 12, 36 months post op.
Implant survival
Number of survived implants out of total implants placed
Time frame: 4, 12, 36 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
full mouth plaque score (FMPS)
% of sites with dental plaque over total measures sites
Time frame: 0., 1., 7., 14. day, and 1., 2., 4., 6., 12., 36. month after implantation
full mouth bleeding score (FMBS)
% of sites with bleeding over total measures sites
Time frame: 0. day, and 4., 12., 36. month after implantation
Probing depth (PPD)
Probing pocket depth
Time frame: 0., 4., 12., 36. month after implantation
Functional implant prosthodontic score (FIPS)
Functional implant prosthodontic score
Time frame: 4 months after implantation, at final restoration delivery
Pain at delivery
Pain numerical rating scale
Time frame: 4 months after implantation, at final restoration delivery