Dental Implants, Single-ToothNCT06407271
Effect of Abutment Configuration on Peri-implant Soft and Hard Tissue in the Esthetic Zone - Randomized Clinical Trial
A study testing CAD/CAM custom ZrO2 healing abutment and Cylindrical ZrO2 healing abutment in people with Dental Implants, Single-Tooth and Dental Implant-Abutment Design, run by Semmelweis University at 1 site in Hungary.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implants, Single-Tooth, Dental Implant-Abutment Design
- What is being tested?
- CAD/CAM custom ZrO2 healing abutment and Cylindrical ZrO2 healing abutment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHungary
- Study dates
- 13 Dec 2023to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Péter Tajti contact
Hungary1 site, 1 recruiting
- Recruiting
Semmelweis University, Department of Prosthodontics
Budapest, Pest County, 1088
Krisztina Mikulás, PhD, 3614591500 ext. 59115, mikulas.krisztina1@semmelweis.hu
Péter Tajti, 3614591500, tajti.peter@semmelweis.hu
About this study
Official title: 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.
Read the 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:
- immediate implantation + cylindrical healing abutment + CAD/CAM screw-retained (on Ti-base), full-countour monolithic zirconium-dioxide restoration
- 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
- Being tested
- CAD/CAM custom ZrO2 healing abutment, Cylindrical ZrO2 healing abutment
- Keywords
- Peri-Implant Tissue Management, CAD-CAM, Dental Implants, Single-Tooth, Dental Implant-Abutment Design
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAD/CAM custom ZrO2 healing abutmentDevice
Also called CAD-CAM custom zirconium-dioxide healing abutment
Application of custom, zirconium-dioxide healing abutment, fabricated with computer aided design and manufacturing, following immediate implantation.
Cylindrical ZrO2 healing abutmentDevice
Also called Cylindrical zirconium-dioxide healing abutment
Application of cylindrical, zirconium-dioxide healing abutment following immediate implantation.
| Study group | Role | What they receive |
|---|---|---|
| CAD/CAM custom ZrO2 healing abutment | Experimental | Application of custom, zirconium-dioxide healing abutment, fabricated with computer aided design and manufacturing, following immediate implantation. Receives: Device: CAD/CAM custom ZrO2 healing abutment |
| Cylindrical ZrO2 healing abutment | Active comparator | Application of cylindrical, zirconium-dioxide healing abutment following immediate implantation. Receives: Device: Cylindrical ZrO2 healing abutment |
What is being measured
The primary outcome is the main question the study is designed to answer.
midfacial keratinized mucosa volume
Volume changes in midfacial mucosa [mm]
Measured: 4, 12, 36 months post op.
midfacial keratinized mucosa width
Keratinized mucosa width [mm]
Measured: 4, 12, 36 months post op.
Keratinized mucosa thickness
Keratinized mucosa thickness with ultrasound [mm]
Measured: before implantation, 4,12, 36 months post op.
Secondary outcomes (10)
soft tissue volume
Follow-up of 2D linear and 3D volumetric changes in soft tissue using intraoral scanner
Measured: 4, 12, 36 months post op.
laser speckle contrast imaging (LSCI)
blood flow measurement with laser speckle contrast imaging
Measured: at 0-7., 0., 1., 4., 7., 14. day, and 1., 2., 4., 6., 12 month after implantation
ultrasound
blood flow measurement with ultrasound
Measured: at 0-7., 0., 1., 4., 7., 14. day, and 1., 2., 4., 6., 12 month after implantation
marginal bone loss
marginal bone loss
Measured: 4, 12, 36 months post op.
Implant survival
Number of survived implants out of total implants placed
Measured: 4, 12, 36 months
full mouth plaque score (FMPS)
% of sites with dental plaque over total measures sites
Measured: 0., 1., 7., 14. day, and 1., 2., 4., 6., 12., 36. month after implantation
full mouth bleeding score (FMBS)
% of sites with bleeding over total measures sites
Measured: 0. day, and 4., 12., 36. month after implantation
Probing depth (PPD)
Probing pocket depth
Measured: 0., 4., 12., 36. month after implantation
Functional implant prosthodontic score (FIPS)
Functional implant prosthodontic score
Measured: 4 months after implantation, at final restoration delivery
Pain at delivery
Pain numerical rating scale
Measured: 4 months after implantation, at final restoration delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start13 Dec 2023
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implants, Single-ToothStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Straumann AG
- Responsible party
- Sponsor
- Investigators
- Krisztina Mikulás, PhD, Principal investigator, Semmelweis University, Department of Prosthodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407271
- Sponsor's protocol ID
- 260/2023
- Status last verified
- Dec 2023
- First submitted
- 12 Apr 2024
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Abutment 3-dimensional Configuration on Peri-implant Soft and Hard Tissue in the Esthetic Zone - Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06407271
- Acronym / sponsor ID
- 260/2023
- Keywords
- Peri-Implant Tissue Management, CAD-CAM, Dental Implants, Single-Tooth, Dental Implant-Abutment Design
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Collaborators
- Institut Straumann AG
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- immediate implantation + cylindrical healing abutment + CAD/CAM screw-retained (on Ti-base), full-countour monolithic zirconium-dioxide restoration
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAD/CAM custom ZrO2 healing abutment | Experimental | Device: CAD/CAM custom ZrO2 healing abutmentApplication of custom, zirconium-dioxide healing abutment, fabricated with computer aided design and manufacturing, following immediate implantation. |
| Cylindrical ZrO2 healing abutment | Active comparator | Device: Cylindrical ZrO2 healing abutmentApplication of cylindrical, zirconium-dioxide healing abutment following immediate implantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- patients over 18 years
- good general health
- good oral hygiene (FMPS < 25%)
- healthy periodontium (PPD < 4mm)
- thick phenotype
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAD/CAM custom ZrO2 healing abutmentAlso: CAD-CAM custom zirconium-dioxide healing abutmentApplication 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 abutmentAlso: Cylindrical zirconium-dioxide healing abutmentApplication of cylindrical, zirconium-dioxide healing abutment following immediate implantation. | Device | Cylindrical ZrO2 healing abutment |
Primary outcome
midfacial keratinized mucosa volume
Time frame: 4, 12, 36 months post op.
Volume changes in midfacial mucosa [mm]
midfacial keratinized mucosa width
Time frame: 4, 12, 36 months post op.
Keratinized mucosa width [mm]
Keratinized mucosa thickness
Time frame: before implantation, 4,12, 36 months post op.
Keratinized mucosa thickness with ultrasound [mm]
10 secondary outcomes
soft tissue volume
Time frame: 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
ultrasound
Time frame: 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.
Implant survival
Time frame: 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
full mouth bleeding score (FMBS)
Time frame: 0. day, and 4., 12., 36. month after implantation
Probing depth (PPD)
Time frame: 0., 4., 12., 36. month after implantation
Functional implant prosthodontic score (FIPS)
Time frame: 4 months after implantation, at final restoration delivery
Pain at delivery
Time frame: 4 months after implantation, at final restoration delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Péter Tajti contact
Krisztina Mikulás, PhD principal investigator
Semmelweis University, Department of Prosthodontics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAD/CAM custom ZrO2 healing abutment and Cylindrical ZrO2 healing abutment in people with Dental Implants, Single-Tooth and Dental Implant-Abutment Design, run by Semmelweis University at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Krisztina Mikulás, PhD (+36309365144, mikulas.krisztina1@semmelweis.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
midfacial keratinized mucosa volume (time frame: 4, 12, 36 months post op.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.