Dental Implants, Single-ToothNCT06425770
Digital vs Conventional Impression in Capturing the Emergence Profile Around Maxillary Anterior Implant-supported Crowns
A study testing indirect digital impression and 3D printed cast, direct digital impression and conventional impresion and cast in people with Dental Implants, Single-Tooth and Dental Impression Technique, run by Semmelweis University at 1 site in Hungary.
Trial summary
This study compares conventional impression and cast fabrication to direct/indirect digital scannig and 3D printed casts regarding their accuracy in replicating the peri-implant emergence profile of single implants in the maxillary anterior region (FDI #15-25). 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 Impression Technique
- What is being tested?
- indirect digital impression and 3D printed cast, direct digital impression and conventional impresion and cast
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteHungary
- Study dates
- 5 Oct 2023to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adult above 18 yo
- No systematic deseases
- Good oral hygene (FMPS < 25%)
- Stable occlusion
- Thick phenotype
- Single missing maxilary anterior (FDI #15-25 position) tooth replaced with osseointegrated bone level impant
Show all 9Show fewer
- Correctly formed soft tissue with CAD/CAM temporary abutment for min. 3 months
- Neighbouring teeth in place and in good condition
- Patient voluntarily accepts and signs the patient leaflets for the trial
Who cannot join
- Active periodontitis
- Peri-implant inflammation
Trial locations and contacts
1 site in 1 country.
Hungary1 site, 1 recruiting
- Recruiting
Semmelweis University, Department of Prosthodontics
Budapest, Pest County, 1088
Krisztina Mikulás, PhD, 3614591500 ext. 59115, mikulas.krisztina1@semmelweis.hu
Xinyi Qian, 3614591500 ext. 59313, qian.xinyi@semmelweis.hu
About this study
Official title: Investigating the Accuracy of Conventional vs Digital Impressions and Conventional vs 3D Fabricated Casts in Capturing the Emergence Profile Around Maxillary Anterior Single Implant-supported Crowns
This study compares conventional impression and cast fabrication to direct/indirect digital scannig and 3D printed casts regarding their accuracy in replicating the peri-implant emergence profile of single implants in the maxillary anterior region (FDI #15-25).
Read the detailed description
Correct design of the peri-implant emergence profile (EP) is crucial for maintaining the health of the supracrestal complex and long-term success of the implant implant-prosthodontics. After its formation with a provisional restoration, its shape needs to be transferred to the final restoration via conventional elastomeric or digital (direct/indirect) impression taking.
Our aims are to investigate around maxillary anterior single implants in patients with thick gingival phenotype:
- the accuracy of direct digital impression vs indirect digital impression vs conventional elastomeric impression in capturing the EP and implant position
- the accuracy of 3D printed cast with conventional gingival mask vs conventional epoxy-resin cast with gingival mask in replicating the EP and implant position
- the amount of soft tissue collapse at 0,2,10,20 minutes following the removal of the provisional restoration in case of direct EP scanning
- Being tested
- indirect digital impression and 3D printed cast, direct digital impression, conventional impresion and cast
- Keywords
- Peri-Implant Emergence Profile, Dental Impression Technique, Dental Implants, Single-Tooth, Esthetics, Dental, Crowns, Denture, Partial, Fixed, Computer-Aided Design
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
indirect digital impression and 3D printed castProcedure or surgery
the provisional restoration will be scanned with intraoral scanner extraorally, based on which a virtual model will be created, from which a 3D printed cast will be created with manually fabricated gingival mask based on the provisional restoration
direct digital impressionProcedure or surgery
the emergence profile will be directly scanned with intraoral scanner at 0, 2, 10, and 20 minutes after removing the provisional restoration
conventional impresion and castProcedure or surgery
conventional impression with elastomer (silicon), from which a high-precision epoxi-resin cast with gingival mask will be created
| Study group | Role | What they receive |
|---|---|---|
| conventional cast | Active comparator | conventional impression with elastomer (silicon), from which a high-precision epoxi-resin cast with gingival mask will be created Receives: Procedure: conventional impresion and cast |
| indirect digital impression and 3D printed cast | Experimental | the provisional restoration will be scanned with intraoral scanner extraorally, based on which a virtual model will be created, from which a 3D printed cast will be created with manually fabricated gingival mask based on the provisional restoration Receives: Procedure: indirect digital impression and 3D printed cast |
| direct digital impression | Experimental | the emergence profile will be directly scanned with intraoral scanner at 0, 2, 10, and 20 minutes after removing the provisional restoration Receives: Procedure: direct digital impression |
What is being measured
The primary outcome is the main question the study is designed to answer.
3D RMS - root mean square difference
The absolute mean deviation between the emergence profiles replicated with different impression techniques along the whole surface of the EP
Measured: at impression taking, 0,2,10,20 mins
Secondary outcomes (4)
Linear vertical soft tissue change
Vertical height change of the buccal gingiva marginal level measured at the mesial and distal papilae and mid-facial levels
Measured: at impression taking, 0,2,10,20 mins
Linear horizontal soft tissue change
Horizontal thickness change of the buccal and palatal gingiva at three levels at each third of the distance between the implant platform and the marginal gingiva.
Measured: at impression taking, 0,2,10,20 mins
2D RMS - root mean square difference
The absolute mean deviation between the emergence profiles replicated with different impression techniques along vertical and horizontal cross-sections.
Measured: at impression taking, 0,2,10,20 mins
Patient reported outome measures - evaluation of the impression method
Patient evaluation of the different types of impression methods on a visual analoge scale based questionnaire
Measured: at the end of each session of the digital and conventional impression taking
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start5 Oct 2023
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dental Implants, Single-ToothStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Krisztina Mikulás, PhD, Principal investigator, Department of Prosthodontics, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06425770
- Sponsor's protocol ID
- 129/2023
- Status last verified
- Jan 2024
- First submitted
- 6 May 2024
- Last updated
- 22 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li J, Chen Z, Wang M, Wang HL, Yu H. Dynamic changes of peri-implant soft tissue after interim restoration removal during a digital intraoral scan. J Prosthet Dent. 2019 Sep;122(3):288-294. doi: 10.1016/j.prosdent.2018.07.020. Epub 2019 Mar 15.
PubMed 30885583Xiong J, Sun W, Huang B, Ji W, Shi B. Effect of the implant-supported provisional restoration on the accuracy of digital peri-implant mucosa replication-A clinical study. Clin Oral Implants Res. 2022 Jun;33(6):598-606. doi: 10.1111/clr.13921. Epub 2022 Mar 26.
PubMed 35290685Monaco C, Scheda L, Baldissara P, Zucchelli G. Implant Digital Impression in the Esthetic Area. J Prosthodont. 2019 Jun;28(5):536-540. doi: 10.1111/jopr.12991. Epub 2018 Dec 3.
PubMed 30357992
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Accuracy of Conventional vs Digital Impressions and Conventional vs 3D Fabricated Casts in Capturing the Emergence Profile Around Maxillary Anterior Single Implant-supported Crowns
- ClinicalTrials.gov ID
- NCT06425770
- Acronym / sponsor ID
- 129/2023
- Keywords
- Peri-Implant Emergence Profile, Dental Impression Technique, Dental Implants, Single-Tooth, Esthetics, Dental, Crowns, Denture, Partial, Fixed, Computer-Aided Design
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 22 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.
This study compares conventional impression and cast fabrication to direct/indirect digital scannig and 3D printed casts regarding their accuracy in replicating the peri-implant emergence profile of single implants in the maxillary anterior region (FDI #15-25).
Detailed description
Correct design of the peri-implant emergence profile (EP) is crucial for maintaining the health of the supracrestal complex and long-term success of the implant implant-prosthodontics. After its formation with a provisional restoration, its shape needs to be transferred to the final restoration via conventional elastomeric or digital (direct/indirect) impression taking.
Our aims are to investigate around maxillary anterior single implants in patients with thick gingival phenotype:
- the accuracy of direct digital impression vs indirect digital impression vs conventional elastomeric impression in capturing the EP and implant position
- the accuracy of 3D printed cast with conventional gingival mask vs conventional epoxy-resin cast with gingival mask in replicating the EP and implant position
- the amount of soft tissue collapse at 0,2,10,20 minutes following the removal of the provisional restoration in case of direct EP scanning
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| conventional cast | Active comparator | Procedure: conventional impresion and castconventional impression with elastomer (silicon), from which a high-precision epoxi-resin cast with gingival mask will be created |
| indirect digital impression and 3D printed cast | Experimental | Procedure: indirect digital impression and 3D printed castthe provisional restoration will be scanned with intraoral scanner extraorally, based on which a virtual model will be created, from which a 3D printed cast will be created with manually fabricated gingival mask based on the provisional restoration |
| direct digital impression | Experimental | Procedure: direct digital impressionthe emergence profile will be directly scanned with intraoral scanner at 0, 2, 10, and 20 minutes after removing the provisional restoration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult above 18 yo
- No systematic deseases
- Good oral hygene (FMPS < 25%)
- Stable occlusion
- Thick phenotype
Key exclusion criteria (2 listed)
- Active periodontitis
- Peri-implant inflammation
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 |
|---|---|---|
| indirect digital impression and 3D printed castthe provisional restoration will be scanned with intraoral scanner extraorally, based on which a virtual model will be created, from which a 3D printed cast will be created with manually fabricated gingival mask based on the provisional restoration | Procedure or surgery | indirect digital impression and 3D printed cast |
| direct digital impressionthe emergence profile will be directly scanned with intraoral scanner at 0, 2, 10, and 20 minutes after removing the provisional restoration | Procedure or surgery | direct digital impression |
| conventional impresion and castconventional impression with elastomer (silicon), from which a high-precision epoxi-resin cast with gingival mask will be created | Procedure or surgery | conventional cast |
Primary outcome
3D RMS - root mean square difference
Time frame: at impression taking, 0,2,10,20 mins
The absolute mean deviation between the emergence profiles replicated with different impression techniques along the whole surface of the EP
4 secondary outcomes
Linear vertical soft tissue change
Time frame: at impression taking, 0,2,10,20 mins
Linear horizontal soft tissue change
Time frame: at impression taking, 0,2,10,20 mins
2D RMS - root mean square difference
Time frame: at impression taking, 0,2,10,20 mins
Patient reported outome measures - evaluation of the impression method
Time frame: at the end of each session of the digital and conventional impression taking
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Background: PubMed 30885583Li J, Chen Z, Wang M, Wang HL, Yu H. Dynamic changes of peri-implant soft tissue after interim restoration removal during a digital intraoral scan. J Prosthet Dent. 2019 Sep;122(3):288-294. doi: 10.1016/j.prosdent.2018.07.020. Epub 2019 Mar 15.
- Background: PubMed 35290685Xiong J, Sun W, Huang B, Ji W, Shi B. Effect of the implant-supported provisional restoration on the accuracy of digital peri-implant mucosa replication-A clinical study. Clin Oral Implants Res. 2022 Jun;33(6):598-606. doi: 10.1111/clr.13921. Epub 2022 Mar 26.
- Background: PubMed 30357992Monaco C, Scheda L, Baldissara P, Zucchelli G. Implant Digital Impression in the Esthetic Area. J Prosthodont. 2019 Jun;28(5):536-540. doi: 10.1111/jopr.12991. Epub 2018 Dec 3.
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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. This study is not recruiting at the moment.
Krisztina Mikulás, PhD principal investigator
Department of Prosthodontics, Semmelweis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing indirect digital impression and 3D printed cast, direct digital impression and conventional impresion and cast in people with Dental Implants, Single-Tooth and Dental Impression Technique, 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 9 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 22 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Krisztina Mikulás, PhD (+3614591500 ext. 59115, mikulas.krisztina1@semmelweis.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3D RMS - root mean square difference (time frame: at impression taking, 0,2,10,20 mins). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06425770, which also lists 3 linked publications.
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 22 May 2024; AzTrials last refreshed its copy on 29 Oct 2026.