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Recruiting NCT06407271

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

No phase Interventional Dental Implants, Single-Tooth Dental Implant-Abutment Design

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CAD/CAM custom ZrO2 healing abutment, Cylindrical ZrO2 healing abutment.
Who it may be relevant to
Registry conditions: Dental Implants, Single-Tooth, Dental Implant-Abutment Design. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hungary
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effect of Abutment 3-dimensional Configuration on Peri-implant Soft and Hard Tissue in the Esthetic Zone - Randomized Clinical Trial

Overview

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

  • Device CAD/CAM custom ZrO2 healing abutment
    Application of custom, zirconium-dioxide healing abutment, fabricated with computer aided design and manufacturing, following immediate implantation.
  • Device Cylindrical ZrO2 healing abutment
    Application of cylindrical, zirconium-dioxide healing abutment following immediate implantation.

Primary outcome measures

  • midfacial keratinized mucosa volume [Time frame: 4, 12, 36 months post op.]
  • midfacial keratinized mucosa width [Time frame: 4, 12, 36 months post op.]
  • Keratinized mucosa thickness [Time frame: before implantation, 4,12, 36 months post op.]
Secondary outcome measures (10)
  • soft tissue volume [Time frame: 4, 12, 36 months post op.]
  • laser speckle contrast imaging (LSCI) [Time frame: at 0-7., 0., 1., 4., 7., 14. day, and 1., 2., 4., 6., 12 month after implantation]
  • ultrasound [Time frame: at 0-7., 0., 1., 4., 7., 14. day, and 1., 2., 4., 6., 12 month after implantation]
  • marginal bone loss [Time frame: 4, 12, 36 months post op.]
  • Implant survival [Time frame: 4, 12, 36 months]
  • full mouth plaque score (FMPS) [Time frame: 0., 1., 7., 14. day, and 1., 2., 4., 6., 12., 36. month after implantation]
  • full mouth bleeding score (FMBS) [Time frame: 0. day, and 4., 12., 36. month after implantation]
  • Probing depth (PPD) [Time frame: 0., 4., 12., 36. month after implantation]
  • Functional implant prosthodontic score (FIPS) [Time frame: 4 months after implantation, at final restoration delivery]
  • Pain at delivery [Time frame: 4 months after implantation, at final restoration delivery]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Hungary · 1 center
  • Semmelweis University, Department of Prosthodontics — Budapest

Identifiers

NCT: NCT06407271 · 260/2023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗