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

May 6, 2024 updated by: Semmelweis University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Péter Tajti
  • Phone Number: +3614591500

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CAD/CAM custom ZrO2 healing abutment
Application of custom, zirconium-dioxide healing abutment, fabricated with computer aided design and manufacturing, following immediate implantation.
Device: CAD/CAM custom ZrO2 healing abutment
Application of custom, zirconium-dioxide healing abutment, fabricated with computer aided design and manufacturing, following immediate implantation.
Other Names:
  • CAD-CAM custom zirconium-dioxide healing abutment
Active Comparator: Cylindrical ZrO2 healing abutment
Application of cylindrical, zirconium-dioxide healing abutment following immediate implantation.
Device: Cylindrical ZrO2 healing abutment
Application of cylindrical, zirconium-dioxide healing abutment following immediate implantation.
Other Names:
  • Cylindrical zirconium-dioxide healing abutment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
midfacial keratinized mucosa volume
Time Frame: 4, 12, 36 months post op.
Volume changes in midfacial mucosa [mm]
4, 12, 36 months post op.
midfacial keratinized mucosa width
Time Frame: 4, 12, 36 months post op.
Keratinized mucosa width [mm]
4, 12, 36 months post op.
Keratinized mucosa thickness
Time Frame: before implantation, 4,12, 36 months post op.
Keratinized mucosa thickness with ultrasound [mm]
before implantation, 4,12, 36 months post op.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
soft tissue volume
Time Frame: 4, 12, 36 months post op.
Follow-up of 2D linear and 3D volumetric changes in soft tissue using intraoral scanner
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
blood flow measurement with laser speckle contrast imaging
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
blood flow measurement with ultrasound
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.
marginal bone loss
4, 12, 36 months post op.
Implant survival
Time Frame: 4, 12, 36 months
Number of survived implants out of total implants placed
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
% of sites with dental plaque over total measures sites
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
% of sites with bleeding over total measures sites
0. day, and 4., 12., 36. month after implantation
Probing depth (PPD)
Time Frame: 0., 4., 12., 36. month after implantation
Probing pocket depth
0., 4., 12., 36. month after implantation
Functional implant prosthodontic score (FIPS)
Time Frame: 4 months after implantation, at final restoration delivery
Functional implant prosthodontic score
4 months after implantation, at final restoration delivery
Pain at delivery
Time Frame: 4 months after implantation, at final restoration delivery
Pain numerical rating scale
4 months after implantation, at final restoration delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Semmelweis University

Collaborators

Institut Straumann AG

Investigators

  • Principal Investigator: Krisztina Mikulás, PhD, Semmelweis University, Department of Prosthodontics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2023

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

December 30, 2028

Study Registration Dates

First Submitted

April 12, 2024

First Submitted That Met QC Criteria

May 6, 2024

First Posted (Actual)

May 9, 2024

Study Record Updates

Last Update Posted (Actual)

May 9, 2024

Last Update Submitted That Met QC Criteria

May 6, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 260/2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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