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

Dental Implants, Single-Tooth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06407271
• Other study ID #: 260/2023
• Status: Recruiting
• Phase: N/A
• Start date: December 13, 2023
• Est. completion date: December 30, 2028

Study information

• Verified date: December 2023
• Source: Semmelweis University
• Contact: Krisztina Mikulás, PhD
• Phone: +36309365144
• Email: mikulas.krisztina1[@]semmelweis.hu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2028
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Implants, Single-Tooth

Intervention

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

Locations

Country	Name	City	State
Hungary	Semmelweis University, Department of Prosthodontics	Budapest	Pest

Sponsors (2)

Lead Sponsor	Collaborator
Semmelweis University	Institut Straumann AG

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	midfacial keratinized mucosa volume	Volume changes in midfacial mucosa [mm]	4, 12, 36 months post op.
Primary	midfacial keratinized mucosa width	Keratinized mucosa width [mm]	4, 12, 36 months post op.
Primary	Keratinized mucosa thickness	Keratinized mucosa thickness with ultrasound [mm]	before implantation, 4,12, 36 months post op.
Secondary	soft tissue volume	Follow-up of 2D linear and 3D volumetric changes in soft tissue using intraoral scanner	4, 12, 36 months post op.
Secondary	laser speckle contrast imaging (LSCI)	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
Secondary	ultrasound	blood flow measurement with ultrasound	at 0-7., 0., 1., 4., 7., 14. day, and 1., 2., 4., 6., 12 month after implantation
Secondary	marginal bone loss	marginal bone loss	4, 12, 36 months post op.
Secondary	Implant survival	Number of survived implants out of total implants placed	4, 12, 36 months
Secondary	full mouth plaque score (FMPS)	% of sites with dental plaque over total measures sites	0., 1., 7., 14. day, and 1., 2., 4., 6., 12., 36. month after implantation
Secondary	full mouth bleeding score (FMBS)	% of sites with bleeding over total measures sites	0. day, and 4., 12., 36. month after implantation
Secondary	Probing depth (PPD)	Probing pocket depth	0., 4., 12., 36. month after implantation
Secondary	Functional implant prosthodontic score (FIPS)	Functional implant prosthodontic score	4 months after implantation, at final restoration delivery
Secondary	Pain at delivery	Pain numerical rating scale	4 months after implantation, at final restoration delivery