Accuracy Evaluation of Implant Impressions: A Prospective Study

NCT06393582 | Not Yet Recruiting

• 1 other identifier: REC-23-05-12-02
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aims of this clinical study are: 1) to compare the accuracy of conventional versus digital impression techniques for implant impressions; 2) to assess the passive fit of the prosthesis constructed from the most accurate impression. Thirty edentulous patients who received 4 - 6 implant and indicated for implant-supported fixed prosthesis will be invited. Full-arch conventional and digital impressions will be made for each patient. Accuracy evaluation will be made and the prosthesis will be constructed from the most accurate impression. Passive fit of the zirconia implant-supported prostheses will be verified at the try-in stage clinically and radiographically.

Conditions

Edentulous Jaw; Dental Implants; Edentulous Mouth

Outcome Measures

Primary Outcomes (3)

• Accuracy of conventional versus digital impression techniques for implant impressions

  Following the best-fit algorithm, the accuracy will be measured in terms of 3D comparison to evaluate the 3D deviations between the digital files (STL files from IOS and digitized conventional working casts) limited to the area of scan bodies.

  6 months

• The passive fit of the prosthesis constructed from the most accurate impression

  Clinical assessment of the prosthesis at the try-in stage using one screw test.

  6 months

• The passive fit of the prosthesis

  Radiographic assessment of the prosthesis by periapical radiograph

  6 months

Study Arms (1)

Accuracy of full-arch implant impressions

EXPERIMENTAL

Conventional and digital impressions will be made for each patient to compare the accuracy.

Procedure: Accuracy of full-arch implant impressions; Procedure: Accuracy of full-arch implant impressions using intraoral scanners

Interventions

Accuracy of full-arch implant impressions PROCEDURE

Conventional impressions for full-arch implant impressions will be digitized and used as a reference for comparison.

Accuracy of full-arch implant impressions

Accuracy of full-arch implant impressions using intraoral scanners PROCEDURE

Digital scanners impressions for full-arch implant impressions will be compared to the reference (conventional) impressions

Accuracy of full-arch implant impressions

Eligibility Criteria

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

You may qualify if:

• Edentulous patients who received implant surgery and indicated for implant-supported fixed prosthesis.
• Patients rehabilitated with fixed full-arch interim prostheses with 4 - 6 implants

You may not qualify if:

• Patients with severe systemic diseases, dementia, or muscle tremors will be excluded from the study.

Sponsors & Collaborators

• University of Sharjah: lead

Related Publications (8)

• Lee H, So JS, Hochstedler JL, Ercoli C. The accuracy of implant impressions: a systematic review. J Prosthet Dent. 2008 Oct;100(4):285-91. doi: 10.1016/S0022-3913(08)60208-5.

  PMID: 18922257 BACKGROUND

• Sorrentino R, Gherlone EF, Calesini G, Zarone F. Effect of implant angulation, connection length, and impression material on the dimensional accuracy of implant impressions: an in vitro comparative study. Clin Implant Dent Relat Res. 2010 May;12 Suppl 1:e63-76. doi: 10.1111/j.1708-8208.2009.00167.x. Epub 2009 May 8.

  PMID: 19438937 BACKGROUND

• Vigolo P, Millstein PL. Evaluation of master cast techniques for multiple abutment implant prostheses. Int J Oral Maxillofac Implants. 1993;8(4):439-46.

  PMID: 8270314 BACKGROUND

• Al Quran FA, Rashdan BA, Zomar AA, Weiner S. Passive fit and accuracy of three dental implant impression techniques. Quintessence Int. 2012 Feb;43(2):119-25.

  PMID: 22257873 BACKGROUND

• Akalin ZF, Ozkan YK, Ekerim A. Effects of implant angulation, impression material, and variation in arch curvature width on implant transfer model accuracy. Int J Oral Maxillofac Implants. 2013 Jan-Feb;28(1):149-57. doi: 10.11607/jomi.2070.

  PMID: 23377060 BACKGROUND

• Papaspyridakos P, Hirayama H, Chen CJ, Ho CH, Chronopoulos V, Weber HP. Full-arch implant fixed prostheses: a comparative study on the effect of connection type and impression technique on accuracy of fit. Clin Oral Implants Res. 2016 Sep;27(9):1099-105. doi: 10.1111/clr.12695. Epub 2015 Sep 16.

  PMID: 26374268 BACKGROUND

• Lee SJ, Gallucci GO. Digital vs. conventional implant impressions: efficiency outcomes. Clin Oral Implants Res. 2013 Jan;24(1):111-5. doi: 10.1111/j.1600-0501.2012.02430.x. Epub 2012 Feb 22.

  PMID: 22353208 BACKGROUND

• Alikhasi M, Siadat H, Nasirpour A, Hasanzade M. Three-Dimensional Accuracy of Digital Impression versus Conventional Method: Effect of Implant Angulation and Connection Type. Int J Dent. 2018 Jun 4;2018:3761750. doi: 10.1155/2018/3761750. eCollection 2018.

  PMID: 29971107 BACKGROUND

MeSH Terms

Conditions

Jaw, Edentulous; Mouth, Edentulous

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Tooth Diseases

Study Officials

• Ahmed Aziz, PhD

  University of Sharjah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Aziz, PhD

CONTACT

+971 65057312; a.aziz@sharjah.ac.ae

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: One group of patients will receive both conventional and digital impressions

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: May 1, 2024
• Study Start: May 1, 2024
• Primary Completion: August 2, 2024
• Study Completion: September 1, 2024
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share