Effect of Abutment 3-dimensional Configuration on Peri-implant Soft and Hard Tissue in the Esthetic Zone - Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dental Implants, Single-Tooth
- Sponsor
- Semmelweis University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- midfacial keratinized mucosa width
- Status
- Recruiting
- Last Updated
- last year
Overview
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
Investigators
Eligibility Criteria
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
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
- •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
Outcomes
Primary Outcomes
midfacial keratinized mucosa width
Time Frame: 4, 12, 36 months post op.
Keratinized mucosa width \[mm\]
Keratinized mucosa thickness
Time Frame: before implantation, 4,12, 36 months post op.
Keratinized mucosa thickness with ultrasound \[mm\]
midfacial keratinized mucosa volume
Time Frame: 4, 12, 36 months post op.
Volume changes in midfacial mucosa \[mm\]
Secondary Outcomes
- Probing depth (PPD)(0., 4., 12., 36. month after implantation)
- Pain at delivery(4 months after implantation, at final restoration delivery)
- ultrasound(at 0-7., 0., 1., 4., 7., 14. day, and 1., 2., 4., 6., 12 month after implantation)
- marginal bone loss(4, 12, 36 months post op.)
- full mouth bleeding score (FMBS)(0. day, and 4., 12., 36. month after implantation)
- Functional implant prosthodontic score (FIPS)(4 months after implantation, at final restoration delivery)
- soft tissue volume(4, 12, 36 months post op.)
- laser speckle contrast imaging (LSCI)(at 0-7., 0., 1., 4., 7., 14. day, and 1., 2., 4., 6., 12 month after implantation)
- full mouth plaque score (FMPS)(0., 1., 7., 14. day, and 1., 2., 4., 6., 12., 36. month after implantation)
- Implant survival(4, 12, 36 months)