Digital vs Conventional Impression in Capturing the Emergence Profile Around Maxillary Anterior Implant-supported Crowns

NCT ID: NCT06425770

Last Updated: 2024-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-05

Study Completion Date

2026-02-01

Brief Summary

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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

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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:

1. the accuracy of direct digital impression vs indirect digital impression vs conventional elastomeric impression in capturing the EP and implant position
2. 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
3. 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

Conditions

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Dental Implants, Single-Tooth Dental Impression Technique

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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conventional cast

conventional impression with elastomer (silicon), from which a high-precision epoxi-resin cast with gingival mask will be created

Group Type ACTIVE_COMPARATOR

conventional impresion and cast

Intervention Type PROCEDURE

conventional 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

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

Group Type EXPERIMENTAL

indirect digital impression and 3D printed cast

Intervention Type PROCEDURE

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 impression

the emergence profile will be directly scanned with intraoral scanner at 0, 2, 10, and 20 minutes after removing the provisional restoration

Group Type EXPERIMENTAL

direct digital impression

Intervention Type PROCEDURE

the emergence profile will be directly scanned with intraoral scanner at 0, 2, 10, and 20 minutes after removing the provisional restoration

Interventions

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indirect digital impression and 3D printed cast

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

Intervention Type PROCEDURE

direct digital impression

the emergence profile will be directly scanned with intraoral scanner at 0, 2, 10, and 20 minutes after removing the provisional restoration

Intervention Type PROCEDURE

conventional impresion and cast

conventional impression with elastomer (silicon), from which a high-precision epoxi-resin cast with gingival mask will be created

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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
* 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

Exclusion Criteria

* Active periodontitis
* Peri-implant inflammation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Semmelweis University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Krisztina Mikulás, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Prosthodontics, Semmelweis University

Locations

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Semmelweis University, Department of Prosthodontics

Budapest, Pest County, Hungary

Site Status RECRUITING

Countries

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Hungary

Central Contacts

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Krisztina Mikulás, PhD

Role: CONTACT

+3614591500 ext. 59115

Xinyi Qian

Role: CONTACT

+3614591500 ext. 59313

Facility Contacts

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Krisztina Mikulás, PhD

Role: primary

3614591500 ext. 59115

Xinyi Qian

Role: backup

3614591500 ext. 59313

References

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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.

Reference Type BACKGROUND
PMID: 30885583 (View on PubMed)

Xiong 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.

Reference Type BACKGROUND
PMID: 35290685 (View on PubMed)

Monaco 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.

Reference Type BACKGROUND
PMID: 30357992 (View on PubMed)

Other Identifiers

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129/2023

Identifier Type: -

Identifier Source: org_study_id

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