Clinical trial NCT05790148: Precision of Three Different Scanbodies Used for Direct Digitalization Technique
Official title: Precision of Different Scanbodies Used for Direct Digital Impression in Fabrication of Implant Supported Fixed Prosthesis: A Methodologic Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prosthesis User
Digitalism
Keywords: digital dentistry
intraoral scanner
implant scanbody
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-03-30
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this clinical trials to evaluate precision of different scanbodies in same participant group. The main guestion it aim to answer is:

1. Are the precision of the three different scanbodies used in direct digitalization the same for the produce of implant-supported prostheses?

Participants are healty and have short edentulous span in posterior region that will receive implant-supported prostheses.

Detailed description: Twenty-five patients receiving two implant supported restorations in treatment of short-span partial edentulism were enrolled into the study. Three different scanbodies, original, non-original and generic, were employed for direct digitalization technique. Full contour PMMA restorations were CAD/CAM fabricated from each digital record, and were evaluated in terms of implant fit, axial- and occlusal-contact. Additionally, patient's impressions for digitalization and delivery procedures were recorded using a visual analog scale. Scanbody scan recordings were subjected to reverse engineering for analytical evaluation of 3D virtual implant positioning.

Eligibility criteria: Inclusion Criteria:

* Be willing to voluntarily participate in the study after reading the informed consent form.
* Adult patient over 18 years of age who has completed growth and development
* Partial edentulism in the functional region for a two-implant-supported restoration with two or three occlusal members
* Having a fixed dentition in the opposing arch
* The occlusal relationship between the jaws does not require vertical and horizontal prosthetic treatment.
* Having bone-level implants placed with "straightforward" surgery according to the SAC classification system \[248\] and without advanced surgical technique

Exclusion Criteria:

* Not voluntarily agreeing to participate in the study after reading the informed consent form
* Having one or more of the conditions for which implant treatment is strictly contraindicated (patients who have received radiation therapy, bone cancer, metabolic disorders)
* Having systemic (steroid therapy, uncontrolled diabetes, immunological disorders, pregnancy) risk factors for implant treatment
* Having local (periodontal discomfort, bruxism, poor oral hygiene) risk factors for implant treatment

Primary outcomes:
measure: Clinical fit
timeFrame: 1 year
measure: occlusal contact
timeFrame: 1 year
measure: interface contact
timeFrame: 1 year
measure: Analytical measurement of 3D implant positions
timeFrame: 1 year
Secondary outcomes:
measure: Visual analog scale
timeFrame: 1 year
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University Faculty of Dentistry Department of Prosthodontics
state: Altındağ
Study officials:
affiliation: Hacettepe University Faculty of Dentistry Department of Prosthodontics Ankara, Turkey
name: Fatmanur Demir, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oh KC, Park JM, Moon HS. Effects of Scanning Strategy and Scanner Type on the Accuracy of Intraoral Scans: A New Approach for Assessing the Accuracy of Scanned Data. J Prosthodont. 2020 Jul;29(6):518-523. doi: 10.1111/jopr.13158. Epub 2020 Jun 26.
citation: Passos L, Meiga S, Brigagao V, Street A. Impact of different scanning strategies on the accuracy of two current intraoral scanning systems in complete-arch impressions: an in vitro study. Int J Comput Dent. 2019;22(4):307-319.