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

NCT06425770 | Unknown

• 1 other identifier: 129/2023
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Dental Implants, Single-Tooth; Dental Impression Technique

Keywords

Peri-Implant Emergence Profile; Dental Impression Technique; Dental Implants, Single-Tooth; Esthetics, Dental; Crowns; Denture, Partial, Fixed; Computer-Aided Design

Outcome Measures

Primary Outcomes (1)

• 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

  at impression taking, 0,2,10,20 mins

Secondary Outcomes (4)

• Linear vertical soft tissue change

  at impression taking, 0,2,10,20 mins

• Linear horizontal soft tissue change

  at impression taking, 0,2,10,20 mins

• 2D RMS - root mean square difference

  at impression taking, 0,2,10,20 mins

• Patient reported outome measures - evaluation of the impression method

  at the end of each session of the digital and conventional impression taking

Other Outcomes (3)

• Pink esthetic score/PES

  at impression taking, definitive prosthetic rehabilitation (2 weeks after impression), 6 and 12 months follow-up

• White esthetic score/WES

  at impression taking, definitive prosthetic rehabilitation (2 weeks after impression), 6 and 12 months follow-up

• functional implant prosthodontic score/FIPS

  at impression taking, definitive prosthetic rehabilitation (2 weeks after impression), 6 and 12 months follow-up

Study Arms (3)

conventional cast

ACTIVE COMPARATOR

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

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

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

Procedure: direct digital impression

Interventions

indirect digital impression and 3D printed cast 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

indirect digital impression and 3D printed cast

direct digital impression PROCEDURE

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

direct digital impression

conventional impresion and cast PROCEDURE

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

conventional cast

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Active periodontitis
• Peri-implant inflammation

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (1)

Semmelweis University, Department of Prosthodontics

Budapest, Pest County, 1088, Hungary

RECRUITING

Related Publications (3)

• 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.

  PMID: 30885583 BACKGROUND

• 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.

  PMID: 35290685 BACKGROUND

• 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.

  PMID: 30357992 BACKGROUND

MeSH Terms

Interventions

POLR1G protein, human

Study Officials

• Krisztina Mikulás, PhD

  Department of Prosthodontics, Semmelweis University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Krisztina Mikulás, PhD

CONTACT

+3614591500; mikulas.krisztina1@semmelweis.hu

Xinyi Qian

CONTACT

+3614591500; qian.xinyi@semmelweis.hu

Study Design

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

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 22, 2024
• Study Start: October 5, 2023
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2026
• Last Updated: May 22, 2024

Record last verified: 2024-01

Locations

HU (1)