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

Dental Implants, Single-Tooth Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06425770
• Other study ID #: 129/2023
• Status: Recruiting
• Phase: N/A
• Start date: October 5, 2023
• Est. completion date: February 1, 2026

Study information

• Verified date: January 2024
• Source: Semmelweis University
• Contact: Krisztina Mikulás, PhD
• Phone: +3614591500
• Email: mikulas.krisztina1[@]semmelweis.hu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: February 1, 2026
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Implants, Single-Tooth
• Dental Impression Technique

Intervention

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

Locations

Country	Name	City	State
Hungary	Semmelweis University, Department of Prosthodontics	Budapest	Pest

Sponsors (1)

Lead Sponsor	Collaborator
Semmelweis University

Country where clinical trial is conducted

Hungary, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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