Clinical trial NCT06425770: Digital vs Conventional Impression in Capturing the Emergence Profile Around Maxillary Anterior Implant-supported Crowns
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2024-05-22
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: 3D RMS - root mean square difference
timeFrame: at impression taking, 0,2,10,20 mins
Secondary outcomes:
measure: Linear vertical soft tissue change
timeFrame: at impression taking, 0,2,10,20 mins
measure: Linear horizontal soft tissue change
timeFrame: at impression taking, 0,2,10,20 mins
measure: 2D RMS - root mean square difference
timeFrame: at impression taking, 0,2,10,20 mins
measure: Patient reported outome measures - evaluation of the impression method
timeFrame: at the end of each session of the digital and conventional impression taking
Other outcomes:
measure: Pink esthetic score/PES
timeFrame: at impression taking, definitive prosthetic rehabilitation (2 weeks after impression), 6 and 12 months follow-up
measure: White esthetic score/WES
timeFrame: at impression taking, definitive prosthetic rehabilitation (2 weeks after impression), 6 and 12 months follow-up
measure: functional implant prosthodontic score/FIPS
timeFrame: at impression taking, definitive prosthetic rehabilitation (2 weeks after impression), 6 and 12 months follow-up
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University, Department of Prosthodontics
state: Pest
Study officials:
affiliation: Department of Prosthodontics, Semmelweis University
name: Krisztina Mikulás, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.