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

NCT06407271 | Recruiting

• 1 other identifier: 260/2023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Peri-Implant Tissue Management; CAD-CAM; Dental Implants, Single-Tooth; Dental Implant-Abutment Design

Outcome Measures

Primary Outcomes (3)

• midfacial keratinized mucosa volume

  Volume changes in midfacial mucosa \[mm\]

  4, 12, 36 months post op.

• midfacial keratinized mucosa width

  Keratinized mucosa width \[mm\]

  4, 12, 36 months post op.

• Keratinized mucosa thickness

  Keratinized mucosa thickness with ultrasound \[mm\]

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

Secondary Outcomes (10)

• soft tissue volume

  4, 12, 36 months post op.

• laser speckle contrast imaging (LSCI)

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

• ultrasound

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

• marginal bone loss

  4, 12, 36 months post op.

• Implant survival

  4, 12, 36 months

Study Arms (2)

CAD/CAM custom ZrO2 healing abutment

EXPERIMENTAL

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

Device: CAD/CAM custom ZrO2 healing abutment

Cylindrical ZrO2 healing abutment

ACTIVE COMPARATOR

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

Device: Cylindrical ZrO2 healing abutment

Interventions

CAD/CAM custom ZrO2 healing abutment DEVICE

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

Also known as: CAD-CAM custom zirconium-dioxide healing abutment

CAD/CAM custom ZrO2 healing abutment

Cylindrical ZrO2 healing abutment DEVICE

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

Also known as: Cylindrical zirconium-dioxide healing abutment

Cylindrical ZrO2 healing abutment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Semmelweis University: lead
• Institut Straumann AG: collaborator

Study Sites (1)

Semmelweis University, Department of Prosthodontics

Budapest, Pest County, 1088, Hungary

RECRUITING

Study Officials

• Krisztina Mikulás, PhD

  Semmelweis University, Department of Prosthodontics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Krisztina Mikulás, PhD

CONTACT

+36309365144; mikulas.krisztina1@semmelweis.hu

Péter Tajti

CONTACT

+3614591500

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: May 9, 2024
• Study Start: December 13, 2023
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2028
• Last Updated: May 9, 2024

Record last verified: 2023-12

Locations

HU (1)