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

Semmelweis University

Status: Enrolling

Conditions: Dental Implants, Single-Tooth; Dental Implant-Abutment Design

Treatments: Device: Cylindrical ZrO2 healing abutment; Device: CAD/CAM custom ZrO2 healing abutment

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06407271

260/2023

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

CAD/CAM custom ZrO2 healing abutment

Experimental group

Description:

Application of custom, zirconium-dioxide healing abutment, fabricated with computer aided design and manufacturing, following immediate implantation.

Treatment:

Device: CAD/CAM custom ZrO2 healing abutment

Cylindrical ZrO2 healing abutment

Active Comparator group

Description:

Application of cylindrical, zirconium-dioxide healing abutment following immediate implantation.

Treatment:

Device: Cylindrical ZrO2 healing abutment