Clinical trial NCT06407271: Effect of Abutment Configuration on Peri-implant Soft and Hard Tissue in the Esthetic Zone - Randomized Clinical Trial
Official title: Effect of Abutment 3-dimensional Configuration on Peri-implant Soft and Hard Tissue in the Esthetic Zone - Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Implants, Single-Tooth
Dental Implant-Abutment Design
Keywords: Peri-Implant Tissue Management
CAD-CAM
Dental Implants, Single-Tooth
Dental Implant-Abutment Design
Lead sponsor: Semmelweis University
Sponsor class: OTHER
Collaborators: name: Institut Straumann AG
First posted: 2024-05-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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
* 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

Primary outcomes:
measure: midfacial keratinized mucosa volume
timeFrame: 4, 12, 36 months post op.
measure: midfacial keratinized mucosa width
timeFrame: 4, 12, 36 months post op.
measure: Keratinized mucosa thickness
timeFrame: before implantation, 4,12, 36 months post op.
Secondary outcomes:
measure: soft tissue volume
timeFrame: 4, 12, 36 months post op.
measure: laser speckle contrast imaging (LSCI)
timeFrame: at 0-7., 0., 1., 4., 7., 14. day, and 1., 2., 4., 6., 12 month after implantation
measure: ultrasound
timeFrame: at 0-7., 0., 1., 4., 7., 14. day, and 1., 2., 4., 6., 12 month after implantation
measure: marginal bone loss
timeFrame: 4, 12, 36 months post op.
measure: Implant survival
timeFrame: 4, 12, 36 months
measure: full mouth plaque score (FMPS)
timeFrame: 0., 1., 7., 14. day, and 1., 2., 4., 6., 12., 36. month after implantation
measure: full mouth bleeding score (FMBS)
timeFrame: 0. day, and 4., 12., 36. month after implantation
measure: Probing depth (PPD)
timeFrame: 0., 4., 12., 36. month after implantation
measure: Functional implant prosthodontic score (FIPS)
timeFrame: 4 months after implantation, at final restoration delivery
measure: Pain at delivery
timeFrame: 4 months after implantation, at final restoration delivery
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University, Department of Prosthodontics
state: Pest
Study officials:
affiliation: Semmelweis University, Department of Prosthodontics
name: Krisztina Mikulás, PhD
role: PRINCIPAL_INVESTIGATOR
References: