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NCT Number: NCT06407271

Effect of Abutment 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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CAD/CAM custom ZrO2 healing abutment

Device

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

Cylindrical ZrO2 healing abutment

Device

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

Other names: Cylindrical zirconium-dioxide healing abutment

Primary outcomes

  1. midfacial keratinized mucosa volume

    Time frame: 4, 12, 36 months post op.

    Volume changes in midfacial mucosa [mm]

  2. midfacial keratinized mucosa width

    Time frame: 4, 12, 36 months post op.

    Keratinized mucosa width [mm]

  3. Keratinized mucosa thickness

    Time frame: before implantation, 4,12, 36 months post op.

    Keratinized mucosa thickness with ultrasound [mm]

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. marginal bone loss

    Time frame: 4, 12, 36 months post op.

    marginal bone loss

  5. Implant survival

    Time frame: 4, 12, 36 months

    Number of survived implants out of total implants placed

  6. 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

  7. full mouth bleeding score (FMBS)

    Time frame: 0. day, and 4., 12., 36. month after implantation

    % of sites with bleeding over total measures sites

  8. Probing depth (PPD)

    Time frame: 0., 4., 12., 36. month after implantation

    Probing pocket depth

  9. Functional implant prosthodontic score (FIPS)

    Time frame: 4 months after implantation, at final restoration delivery

    Functional implant prosthodontic score

  10. Pain at delivery

    Time frame: 4 months after implantation, at final restoration delivery

    Pain numerical rating scale

Study contacts

Contact information is provided by the study sponsor or research team.

Krisztina Mikulás, PhD

CONTACT

[email protected]

+36309365144

Péter Tajti

CONTACT

+3614591500

Sponsors and collaborators

Lead sponsor

Semmelweis University

Other

Collaborators

  • Institut Straumann AG

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2028
First posted
May 9, 2024
Registry last updated
May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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