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

Not Applicable

Recruiting

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

• Registration Number: NCT06425770
• Lead Sponsor: Semmelweis University

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).

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 Timeline

• Study Start: 2023-10-05
• Status Verified: 2024-01
• Study First Submitted: 2024-05-06
• Study First Submitted QC: 2024-05-21
• Last Update Submitted: 2024-05-21
• Study First Posted: 2024-05-22
• Last Update Posted: 2024-05-22
• Primary Completion: 2025-02-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
direct digital impression	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
conventional cast	conventional impresion and cast	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	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

Primary Outcome Measures

Name	Time	Method
3D RMS - root mean square difference	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

Secondary Outcome Measures

Name	Time	Method
Linear vertical soft tissue change	at impression taking, 0,2,10,20 mins	Vertical height change of the buccal gingiva marginal level measured at the mesial and distal papilae and mid-facial levels
Linear horizontal soft tissue change	at impression taking, 0,2,10,20 mins	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.
2D RMS - root mean square difference	at impression taking, 0,2,10,20 mins	The absolute mean deviation between the emergence profiles replicated with different impression techniques along vertical and horizontal cross-sections.
Patient reported outome measures - evaluation of the impression method	at the end of each session of the digital and conventional impression taking	Patient evaluation of the different types of impression methods on a visual analoge scale based questionnaire

Trial Locations

Locations (1)

Semmelweis University, Department of Prosthodontics; 🇭🇺 Budapest, Pest, Hungary