Dental Implants, Single-Tooth, Dental Impression Technique
Conditions
Keywords
Peri-Implant Emergence Profile, Dental Impression Technique, Dental Implants, Single-Tooth, Esthetics, Dental, Crowns, Denture, Partial, Fixed, Computer-Aided Design
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
Interventions
PROCEDUREindirect 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
PROCEDUREdirect digital impression
the emergence profile will be directly scanned with intraoral scanner at 0, 2, 10, and 20 minutes after removing the provisional restoration
PROCEDUREconventional impresion and cast
conventional impression with elastomer (silicon), from which a high-precision epoxi-resin cast with gingival mask will be created
Sponsors
Semmelweis University
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| functional implant prosthodontic score/FIPS | at impression taking, definitive prosthetic rehabilitation (2 weeks after impression), 6 and 12 months follow-up | functional implant prosthodontic score of the definitive restoration |
| White esthetic score/WES | at impression taking, definitive prosthetic rehabilitation (2 weeks after impression), 6 and 12 months follow-up | white esthetic score of the definitive restoration |
| Pink esthetic score/PES | at impression taking, definitive prosthetic rehabilitation (2 weeks after impression), 6 and 12 months follow-up | pink esthetic score of the definitive restoration |
Countries
Hungary
Contacts
Primary ContactKrisztina Mikulás, PhD
Backup ContactXinyi Qian
Outcome results
None listed