Effect of Abutment Configuration on Peri-implant Soft and Hard Tissue in the Esthetic Zone - Randomized Clinical Trial
- Conditions
- Dental Implants, Single-ToothDental Implant-Abutment Design
- Interventions
- Device: CAD/CAM custom ZrO2 healing abutmentDevice: Cylindrical ZrO2 healing abutment
- Registration Number
- NCT06407271
- Lead Sponsor
- Semmelweis University
- Brief 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- patients over 18 years
- 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
- general ill health
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CAD/CAM custom ZrO2 healing abutment 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 Cylindrical ZrO2 healing abutment Application of cylindrical, zirconium-dioxide healing abutment following immediate implantation.
- Primary Outcome Measures
Name Time Method midfacial keratinized mucosa width 4, 12, 36 months post op. Keratinized mucosa width \[mm\]
midfacial keratinized mucosa volume 4, 12, 36 months post op. Volume changes in midfacial mucosa \[mm\]
Keratinized mucosa thickness before implantation, 4,12, 36 months post op. Keratinized mucosa thickness with ultrasound \[mm\]
- Secondary Outcome Measures
Name Time Method Probing depth (PPD) 0., 4., 12., 36. month after implantation Probing pocket depth
Pain at delivery 4 months after implantation, at final restoration delivery Pain numerical rating scale
ultrasound at 0-7., 0., 1., 4., 7., 14. day, and 1., 2., 4., 6., 12 month after implantation blood flow measurement with ultrasound
marginal bone loss 4, 12, 36 months post op. marginal bone loss
full mouth bleeding score (FMBS) 0. day, and 4., 12., 36. month after implantation % of sites with bleeding over total measures sites
Functional implant prosthodontic score (FIPS) 4 months after implantation, at final restoration delivery Functional implant prosthodontic score
soft tissue volume 4, 12, 36 months post op. Follow-up of 2D linear and 3D volumetric changes in soft tissue using intraoral scanner
laser speckle contrast imaging (LSCI) 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
full mouth plaque score (FMPS) 0., 1., 7., 14. day, and 1., 2., 4., 6., 12., 36. month after implantation % of sites with dental plaque over total measures sites
Implant survival 4, 12, 36 months Number of survived implants out of total implants placed
Trial Locations
- Locations (1)
Semmelweis University, Department of Prosthodontics
🇭🇺Budapest, Pest, Hungary