NCT06407271

Effect of Abutment Configuration on Peri-implant Soft and Hard Tissue in the Esthetic Zone - Randomized Clinical Trial

Effect of Abutment 3-dimensional Configuration on Peri-implant Soft and Hard Tissue in the Esthetic Zone - Randomized Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Semmelweis University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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

Conditions

• Dental Implants, Single-Tooth
• Dental Implant-Abutment Design

Interventions

Type	Name	Description
DEVICE	CAD/CAM custom ZrO2 healing abutment	Application of custom, zirconium-dioxide healing abutment, fabricated with computer aided design and manufacturing, following immediate implantation.
DEVICE	Cylindrical ZrO2 healing abutment	Application of cylindrical, zirconium-dioxide healing abutment following immediate implantation.

Timeline

• Start date: 2023-12-13
• Primary completion: 2025-12-30
• Completion: 2028-12-30
• First posted: 2024-05-09
• Last updated: 2024-05-09

Locations

1 site across 1 country: Hungary