Assessing the Influence of Implant Scanning Techniques on the Accuracy of Maxillary Complete-Arch Digital Scans for Implant Overdentures: A Comparative Clinical Study
NCT ID: NCT07295899
Last Updated: 2025-12-22
Study Results
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Basic Information
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NOT_YET_RECRUITING
1 participants
OBSERVATIONAL
2025-12-15
2026-01-15
Brief Summary
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The purpose of the present in vivo study is to compare the trueness and the precision of the recorded implant's position, between conventional and novel implant acquisition protocols.
Detailed Description
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The patient has to be treated with the placement of four implants and to be planned to be restored with an implant-supported overdenture.In total 3 different scan body systems are going to be evaluated in the present research: conventional scan-bodies (Cares Mono Scan body, Straumann), scan-bodies designed for a horizontal intraoral scanning (Apollo and Reference Scan body, Dynamic abutment), reverse scan bodies (ReveX, Straumann; Scanalog, Dynamic abutment) The scan-bodies will be hand-tightening over the multi-units, which previously will be fixed on 4 implants in patient's maxilla. Each one of the evaluated scan bodies is going to be scanned using an intraoral scanner Trios 5 (3Shape). The verified dentate scan path
recommended by the manufacturer is going to be followed, to scan the reference cast 10 times, for each one of the evaluated scan body systems. The digital scans for each group are going to be performed without removing the scan-bodies in order to eliminate the effect of scan body fit. Finally, an analog impression of splinted impression posts is going to be taken in order to serve as a reference. Based to the analog impression a reference cast is going to be fabricated using a plaster (Type 3, Moldano, Kulzer) and be scanned by a desktop scanner (T710, Medit) using laboratory scan bodies to serve as a reference.The STL files for each evaluated group along with the scans from the industrial scanner will be imported in a metrology software (Geomagic, control X). The digital model derived from each evaluated group is going to be superimposed with the model obtained from the industrial scanner respectively. In order to achieve an accurate superimposition, first "align between measured data" function will be utilized, followed by "best-fit alignment". During the alignment, the area of the scan bodies will be excluded, in order to prevent them from influencing the alignment and the subsequent evaluation. This will be accomplished by using the "use select data only" function. In order to standardize the aforementioned procedure, all superimposed models will be cut simultaneously in the same region.
Afterwards, the overall deviation will be calculated, by using "3D compare" function on Geomagic software, by creating a color map in superimposed digital models to qualitative analyze any 3D deviation. The color map is going to be ranged from -0.5mm to +0.5mm. Mean discrepancy is going to be measured in root mean square RMS, which is a mathematical measure of magnitude of a set of numbers. Trueness will be defined in terms of the mean discrepancy on the positions of the implant abutments, between the digitized by the industrial scanner reference cast and each evaluated group. Precision will be described as the standard deviation of the mean absolute discrepancies computed between the digitized by the industrial scanner reference cast and each evaluated group. A smaller SD indicates that measurements are more precise and consistent, while larger SD will imply greater variability.A power analysis was performed utilizing the G\*Power software (G\*Power, Heinrich- Heine-Universität Düsseldorf, Germany). The total sample size was calculated based on an effect size of 0.4, an alpha error probability of 0.05, a power of 0.8 and an estimated correlation between measurements of 0.5. The power analysis revealed that a minimum of 10 data sets per evaluated group is required to perform the present study. Statistical analysis will be performed using SPSS statistics software (version 29, IBM software).
Descriptive statistics will be calculated for each evaluated group. The Shapiro-Wilk test will be performed in order to test if the data are normally distributed (P\<0.05). For the trueness and the precision, post-hoc analysis (Tukey, Scheffe) will be conducted to assess which evaluated implant acquisition technique will be statistically significantly different.
Fisher's exact test will be used to assess the association between the implant acquisition method and the accuracy of the fit. The level of significance will be set at 0.05. The agreement of fit assessment between the two experienced clinicians will be tested with κ statistics (Cohen's k-score).
Conditions
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Keywords
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Scan body (Apollo design)
Intraoral scanning
Different designs of scanbodies will be used
Scan body (Conventional)
Intraoral scanning
Different designs of scanbodies will be used
Scan body (Reverse design)
Intraoral scanning
Different designs of scanbodies will be used
Interventions
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Intraoral scanning
Different designs of scanbodies will be used
Eligibility Criteria
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Inclusion Criteria
\-
Exclusion Criteria
1. Uncontrolled Systemic Conditions
Dental procedures-especially invasive ones-are often postponed if the condition is not medically stable:
• Uncontrolled Hypertension
BP typically \>180/110 mmHg is considered unsafe for elective dental care.
Risk: stroke, heart attack during treatment.
• Uncontrolled Diabetes
High blood glucose (e.g., \>300 mg/dL) increases infection risk and poor healing.
• Uncontrolled Thyroid Disease
Hyperthyroidism raises risk of thyroid storm, especially with epinephrine.
2. Recent Major Cardiac Events
Elective dental treatment is usually deferred for:
* Heart attack (MI) within past 6 months
* Stroke within past 6 months
* Unstable angina
* Severe arrhythmias
* Decompensated heart failure
These conditions can make dental stress or anesthesia dangerous.
3. Infectious Diseases (Active Phase)
Dental treatment may be delayed to protect the patient or others.
* Active Herpetic Lesions (Cold Sores) around the mouth
* Active Tuberculosis (TB)
* COVID-19 or other acute respiratory infections with fever
4. Hematologic Disorders
If blood does not clot properly, dental surgery can be risky.
• Severe Thrombocytopenia
Platelets too low for safe extraction or surgery.
• Hemophilia or bleeding disorders
Require management with a hematologist first.
• Patients on certain anticoagulants (e.g., warfarin with very high INR)
May need medical adjustment before invasive care.
5. Pregnancy (Certain Situations)
Most dental care is safe, but some procedures are postponed:
Elective treatments during 1st trimester
Avoid certain medications (e.g., some anesthetics, antibiotics, NSAIDs)
Severe hypertension or pregnancy complications (eclampsia)
6. Severe Psychiatric Conditions (Unstable)
When a patient cannot cooperate safely:
Acute psychosis
Severe anxiety uncontrolled by medication
Need medical stabilization vs. dental sedation coordination
7. Substance Intoxication
Dental care is not performed if patient is intoxicated with:
Alcohol
Recreational drugs (especially stimulants like cocaine or meth)
Risk of cardiovascular events or inability to consent.
18 Years
MALE
Yes
Sponsors
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National and Kapodistrian University of Athens
OTHER
Responsible Party
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Panagiotis Ntovas
PhD Canditate, Department of Operative Dentistry, School of Dentistry, Greece
Central Contacts
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References
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Wu HK, Wang J, Chen G, Huang X, Deng F, Li Y. Effect of novel prefabricated auxiliary devices attaching to scan bodies on the accuracy of intraoral scanning of complete-arch with multiple implants: An in-vitro study. J Dent. 2023 Nov;138:104702. doi: 10.1016/j.jdent.2023.104702. Epub 2023 Sep 14.
Carneiro Pereira AL, Souza Curinga MR, Melo Segundo HV, da Fonte Porto Carreiro A. Factors that influence the accuracy of intraoral scanning of total edentulous arches rehabilitated with multiple implants: A systematic review. J Prosthet Dent. 2023 Jun;129(6):855-862. doi: 10.1016/j.prosdent.2021.09.001. Epub 2021 Oct 13.
Gomez-Polo M, Donmez MB, Cakmak G, Yilmaz B, Revilla-Leon M. Influence of implant scan body design (height, diameter, geometry, material, and retention system) on intraoral scanning accuracy: A systematic review. J Prosthodont. 2023 Dec;32(S2):165-180. doi: 10.1111/jopr.13774. Epub 2023 Oct 18.
Revilla-Leon M, Smith Z, Methani MM, Zandinejad A, Ozcan M. Influence of scan body design on accuracy of the implant position as transferred to a virtual definitive implant cast. J Prosthet Dent. 2021 Jun;125(6):918-923. doi: 10.1016/j.prosdent.2020.03.019. Epub 2020 May 31.
Papaspyridakos P, Bedrossian A, Kudara Y, Ntovas P, Bokhary A, Chochlidakis K. Reverse scan body: A complete digital workflow for prosthesis prototype fabrication. J Prosthodont. 2023 Jun;32(5):452-457. doi: 10.1111/jopr.13664. Epub 2023 Mar 3.
Giglio GD, Giglio AB, Tarnow DP. A Paradigm Shift Using Scan Bodies to Record the Position of a Complete Arch of Implants in a Digital Workflow. Int J Periodontics Restorative Dent. 2024;44(1):115-126. doi: 10.11607/prd.6733.
Other Identifiers
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47/17.07.2025
Identifier Type: -
Identifier Source: org_study_id