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

ConditionsDental Implants, Single-ToothDental Implant-Abutment Design
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSemmelweis University

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

patients over 18 years

good general health

good oral hygiene (FMPS < 25%)

healthy periodontium (PPD < 4mm)

Disqualifiers

general ill health

general surgical or oral surgery contraindication

a patient who has undergone local radiotherapy

active periodontal inflammation, inflammation of the alveolar cavity

Trial design

Design model

Parallel

Treatments tested in this trial

  • CAD/CAM custom ZrO2 healing abutment

    Device

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

  • Cylindrical ZrO2 healing abutment

    Device

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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: CAD/CAM custom ZrO2 healing abutmentExperimental treatment 1 intervention
Group B: Cylindrical ZrO2 healing abutmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

midfacial keratinized mucosa volume

Volume changes in midfacial mucosa \[mm\]

Time frame
4, 12, 36 months post op.
2

midfacial keratinized mucosa width

Keratinized mucosa width \[mm\]

Time frame
4, 12, 36 months post op.
3

Keratinized mucosa thickness

Keratinized mucosa thickness with ultrasound \[mm\]

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

Secondary outcomes

1

soft tissue volume

Follow-up of 2D linear and 3D volumetric changes in soft tissue using intraoral scanner

Time frame
4, 12, 36 months post op.
2

laser speckle contrast imaging (LSCI)

blood flow measurement with laser speckle contrast imaging

Time frame
at 0-7., 0., 1., 4., 7., 14. day, and 1., 2., 4., 6., 12 month after implantation
3

ultrasound

blood flow measurement with ultrasound

Time frame
at 0-7., 0., 1., 4., 7., 14. day, and 1., 2., 4., 6., 12 month after implantation
4

marginal bone loss

marginal bone loss

Time frame
4, 12, 36 months post op.

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Semmelweis University, Department of ProsthodonticsRecruiting1088, Budapest, Pest CountyHungaryHungary

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Semmelweis University

Lead sponsor

Institut Straumann AG

Collaborator

Source ClinicalTrials.gov
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