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

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).

Study Overview

• Status: Recruiting
• Conditions: Dental Implants, Single-Tooth; Dental Impression Technique
• Intervention / Treatment: Procedure: conventional impresion and cast; Procedure: indirect digital impression and 3D printed cast; Procedure: direct digital impression

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:

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

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Krisztina Mikulás, PhD; Phone Number: 59115 +3614591500; Email: mikulas.krisztina1@semmelweis.hu
• Study Contact Backup: Name: Xinyi Qian; Phone Number: 59313 +3614591500; Email: qian.xinyi@semmelweis.hu

Study Locations

• Hungary
  • Pest
    • Budapest, Pest, Hungary, 1088
      • Recruiting
      • Semmelweis University, Department of Prosthodontics
      • Contact: Krisztina Mikulás, PhD; Phone Number: 59115 3614591500; Email: mikulas.krisztina1@semmelweis.hu
      • Contact: Xinyi Qian; Phone Number: 59313 3614591500; Email: qian.xinyi@semmelweis.hu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: conventional cast; conventional impression with elastomer (silicon), from which a high-precision epoxi-resin cast with gingival mask will be created	Procedure: conventional impresion and cast; conventional impression with elastomer (silicon), from which a high-precision epoxi-resin cast with gingival mask will be created
Experimental: 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	Procedure: 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
Experimental: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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	at the end of each session of the digital and conventional impression taking

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pink esthetic score/PES	pink esthetic score of the definitive restoration	at impression taking, definitive prosthetic rehabilitation (2 weeks after impression), 6 and 12 months follow-up
White esthetic score/WES	white esthetic score of the definitive restoration	at impression taking, definitive prosthetic rehabilitation (2 weeks after impression), 6 and 12 months follow-up
functional implant prosthodontic score/FIPS	functional implant prosthodontic score of the definitive restoration	at impression taking, definitive prosthetic rehabilitation (2 weeks after impression), 6 and 12 months follow-up

Collaborators and Investigators

• Sponsor: Semmelweis University
• Investigators: Principal Investigator: Krisztina Mikulás, PhD, Department of Prosthodontics, Semmelweis University

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2023
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: May 6, 2024
• First Submitted That Met QC Criteria: May 21, 2024
• First Posted (Actual): May 22, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2024
• Last Update Submitted That Met QC Criteria: May 21, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Dental Implants, Single-Tooth; Crowns; Dental Impression Technique; Computer-Aided Design; Esthetics, Dental; Peri-Implant Emergence Profile; Denture, Partial, Fixed
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Cysteine Proteinase Inhibitors; Calpastatin
• Other Study ID Numbers: 129/2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No