Dental Implant-Abutment Design, Dental Implants, Single-Tooth
Conditions
Keywords
Peri-Implant Tissue Management, CAD-CAM, Dental Implants, Single-Tooth, Dental Implant-Abutment Design
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
Interventions
DEVICECAD/CAM custom ZrO2 healing abutment
Application of custom, zirconium-dioxide healing abutment, fabricated with computer aided design and manufacturing, following immediate implantation.
DEVICECylindrical ZrO2 healing abutment
Application of cylindrical, zirconium-dioxide healing abutment following immediate implantation.
Sponsors
Institut Straumann AG
Semmelweis University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| midfacial keratinized mucosa volume | 4, 12, 36 months post op. | Volume changes in midfacial mucosa \[mm\] |
| midfacial keratinized mucosa width | 4, 12, 36 months post op. | Keratinized mucosa width \[mm\] |
| Keratinized mucosa thickness | before implantation, 4,12, 36 months post op. | Keratinized mucosa thickness with ultrasound \[mm\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| marginal bone loss | 4, 12, 36 months post op. | marginal bone loss |
| Implant survival | 4, 12, 36 months | Number of survived implants out of total implants placed |
| 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 |
| soft tissue volume | 4, 12, 36 months post op. | Follow-up of 2D linear and 3D volumetric changes in soft tissue using intraoral scanner |
| Probing depth (PPD) | 0., 4., 12., 36. month after implantation | Probing pocket depth |
| Functional implant prosthodontic score (FIPS) | 4 months after implantation, at final restoration delivery | Functional implant prosthodontic score |
| Pain at delivery | 4 months after implantation, at final restoration delivery | Pain numerical rating scale |
| full mouth bleeding score (FMBS) | 0. day, and 4., 12., 36. month after implantation | % of sites with bleeding over total measures sites |
| 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 |
| ultrasound | at 0-7., 0., 1., 4., 7., 14. day, and 1., 2., 4., 6., 12 month after implantation | blood flow measurement with ultrasound |
Countries
Hungary
Contacts
Primary ContactKrisztina Mikulás, PhD
Backup ContactPéter Tajti
Outcome results
None listed