Clinical Evaluation of the Effect of the Scanning Pattern on Complete-arch Implant Scans

NCT05985226 | Unknown

• 1 other identifier: C.I. 22/645-E
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to analyze and compare the influence of different scanning strategies (zigzag with conventional scan body, circumferential with conventional scan body, surface blocking with conventional scan body, zigzag with low profile scan body, standard strategy with low profile scan body) on the accuracy of the records obtained for a case of fixed rehabilitation on full-arch dental implants in patients of both sexes, over 18 years of age who will be rehabilitated with fixed prostheses on full-arch implants. The main question it aims to answer is if there will be significant differences in scanning accuracy (trueness and precision) between the different groups of digital impressions compared to the reference model (conventional impression with rigid splinting) and types of scan bodies. The patient will undergo conventional impression-taking (with pastes) to obtain the reference model. Subsequently, digital records will be taken with the intra-oral scanner until completing 15 records per group, out of a total of 6 experimental groups (1.- zigzag with conventional scan body (ZZ-SBL), 2.- circumferential with conventional scan body (C-SBL), 3.- surface blocking with scan conventional body (B-SBL), 4.- zigzag with low profile scan body (ZZ-SBL), 5.- a standard strategy with low profile scan body (STD-SBL), 6.- single pass with low profile scan body ( OP-SBL) These experimental groups will be scanned directly in the patient's mouth, to later be compared with the reference model, called the "master model". Researchers will compare the six different methodologies for taking digital impressions to demonstrate which strategies are more accurate, faster, and require fewer frames.

Conditions

Dental Prosthesis, Implant-Supported

Keywords

Accuracy; intraoral scanners; digital impressions; complete arch; implant-supported dental prostheses

Outcome Measures

Primary Outcomes (1)

• Accuracy

  Micrometers (root mean square deviations)

  Up to 1 year

Secondary Outcomes (2)

• Number of photograms

  Up to 1 year

• clinical scan time

  Up to 1 year

Study Arms (1)

scanning strategies

EXPERIMENTAL

6 experimental groups will be created based on the strategy-scan body used (1.- zigzag with conventional scan body (ZZ-SBL), 2.- circumferential with conventional scan body (C-SBL), 3.- surface blocking with scan conventional body (B-SBL), 4.- zigzag with low profile scan body (ZZ-SBL), 5.- a standard strategy with low profile scan body (STD-SBL), 6.- single pass with low profile scan body ( OP-SBL) These experimental groups will be scanned directly in the patient's mouth, to later be compared with the reference model, called the "master model".

Device: intraoral scan

Interventions

intraoral scan DEVICE

All the experimental groups will be developed with an intraoral scanner, a device that emits light and collects the image projected by that light, to build a 3-dimensional digital model. It is more comfortable than conventional impressions and it is a harmless, non-intrusive, and painless procedure.

scanning strategies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient susceptible to rehabilitation with a fixed prosthesis on implants.
• Good general health (ASA I and ASA II),

You may not qualify if:

• Joint problems or limitation of opening.
• Patients who, after reading the information sheet the patient and informed consent, and clarified any doubts, do not agree to participate in the study

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

School of Dentistry, Complutense University. Pza Ramón y Cajal s/n.

Madrid, 28040, Spain

RECRUITING

Related Publications (45)

• Gomez-Polo M, Cascos R, Ortega R, Barmak AB, Kois JC, Revilla-Leon M. Influence of arch location and scanning pattern on the scanning accuracy, scanning time, and number of photograms of complete-arch intraoral digital implant scans. Clin Oral Implants Res. 2023 Jun;34(6):591-601. doi: 10.1111/clr.14069. Epub 2023 Apr 13.

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• Sallorenzo A, Gomez-Polo M. Comparative study of the accuracy of an implant intraoral scanner and that of a conventional intraoral scanner for complete-arch fixed dental prostheses. J Prosthet Dent. 2022 Nov;128(5):1009-1016. doi: 10.1016/j.prosdent.2021.01.032. Epub 2021 Apr 7.

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• Revilla-Leon M, Sicilia E, Agustin-Panadero R, Gomez-Polo M, Kois JC. Clinical evaluation of the effects of cutting off, overlapping, and rescanning procedures on intraoral scanning accuracy. J Prosthet Dent. 2023 Nov;130(5):746-754. doi: 10.1016/j.prosdent.2021.10.017. Epub 2022 Jan 6.

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• Revilla-Leon M, Gohil A, Barmak AB, Gomez-Polo M, Perez-Barquero JA, Att W, Kois JC. Influence of ambient temperature changes on intraoral scanning accuracy. J Prosthet Dent. 2023 Nov;130(5):755-760. doi: 10.1016/j.prosdent.2022.01.012. Epub 2022 Feb 21.

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• Revilla-Leon M, Quesada-Olmo N, Gomez-Polo M, Sicilia E, Farjas-Abadia M, Kois JC. Influence of rescanning mesh holes on the accuracy of an intraoral scanner: An in vivo study. J Dent. 2021 Dec;115:103851. doi: 10.1016/j.jdent.2021.103851. Epub 2021 Oct 15.

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• Revilla-Leon M, Subramanian SG, Att W, Krishnamurthy VR. Analysis of Different Illuminance of the Room Lighting Condition on the Accuracy (Trueness and Precision) of An Intraoral Scanner. J Prosthodont. 2021 Feb;30(2):157-162. doi: 10.1111/jopr.13276. Epub 2020 Nov 7.

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• Revilla-Leon M, Jiang P, Sadeghpour M, Piedra-Cascon W, Zandinejad A, Ozcan M, Krishnamurthy VR. Intraoral digital scans: Part 2-influence of ambient scanning light conditions on the mesh quality of different intraoral scanners. J Prosthet Dent. 2020 Nov;124(5):575-580. doi: 10.1016/j.prosdent.2019.06.004. Epub 2019 Dec 20.

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Study Officials

• Miguel Gómez-Polo, PhD, DDS

  Universidad Complutense de Madrid

  STUDY DIRECTOR

Central Study Contacts

Miguel Gómez-Polo, PhD, DDS

CONTACT

+34 659390001; mgomezpo@ucm.es

Miguel Gómez-Polo

CONTACT

+34 659390001; mgomezpo@ucm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: August 14, 2023
• Study Start: April 1, 2023
• Primary Completion: August 31, 2023
• Study Completion: September 1, 2023
• Last Updated: August 14, 2023

Record last verified: 2022-11

Locations

ES (1)