Digital Intraoral Scanning With and Without Prefabricated Landmarks Versus Conventional Impression Technique

NCT06592066 | Not Yet Recruiting

• 1 other identifier: FDASU-Rec ID022403
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this clinical trial is to evaluate the accuracy of digital implant impressions with or without prefabricated landmarks between scan bodies compared to conventional impression technique in mandibular full-arch implant cases.

Conditions

Dental Impression Technique

Outcome Measures

Primary Outcomes (1)

• The accuracy of digital intraoral scanning of full-arch mandibular implants.

  Improving digital intraoral scanning of mandibular full-arch implant cases will facilitate the impression procedure, omit the drawback of conventional impression, improve the passive fit, and address the biomechanical considerations of the final-full arch prosthesis.

  Baseline

Study Arms (3)

Splinted Conventional Impression Technique

ACTIVE COMPARATOR

Splinted open tray conventional impression technique will be used for the mandibular full-arch implants, utilizing medium body impression material.

Device: Splinted Open Top Tay Conventional Impression Technique

Digital impression technique with scan bodies

EXPERIMENTAL

Digital impression technique will be employed for mandibular full-arch implants, using intraoral scanning with scan bodies to capture the implant positions.

Device: Digital Impression by using Intraoral Scanning of Scan Bodies

Digital impression technique with scan bodies with Prefabricated Landmarks

EXPERIMENTAL

Digital impression technique will be employed for mandibular full-arch implants, using intraoral scanning with scan bodies with prefabricated landmarks to capture the implant positions.

Device: Digital Impression by using Intraoral Scanning of Scan Bodies with Prefabricated Landmarks

Interventions

Digital Impression by using Intraoral Scanning of Scan Bodies DEVICE

intraoral scanning will be used to capture the positions of full-arch mandibular implants with the aid of scan bodies.

Digital impression technique with scan bodies

Digital Impression by using Intraoral Scanning of Scan Bodies with Prefabricated Landmarks DEVICE

intraoral scanning will be used to capture the positions of full-arch mandibular implants with the aid of scan bodies with prefabricated landmarks in place.

Digital impression technique with scan bodies with Prefabricated Landmarks

Splinted Open Top Tay Conventional Impression Technique DEVICE

Splinted open-top tray conventional impression technique will be preformed by using medium body silicone impression material.

Splinted Conventional Impression Technique

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with completely edentulous mandible, non-smokers, 50-70 years in age, have Good oral hygiene and motivation.

You may not qualify if:

• patients with major systemic diseases that may affect osseointegration as uncontrolled diabetes mellitus, the need for extensive bone grafting in planned implant site, pregnancy, patients under bisphosphonate treatment, and limited mouth-opening for executing the guided implant surgery.

Sponsors & Collaborators

• Ain Shams University: lead

Related Publications (18)

• Papaspyridakos P, Mokti M, Chen CJ, Benic GI, Gallucci GO, Chronopoulos V. Implant and prosthodontic survival rates with implant fixed complete dental prostheses in the edentulous mandible after at least 5 years: a systematic review. Clin Implant Dent Relat Res. 2014 Oct;16(5):705-17. doi: 10.1111/cid.12036. Epub 2013 Jan 11.

  PMID: 23311617 BACKGROUND

• Goodacre CJ, Bernal G, Rungcharassaeng K, Kan JY. Clinical complications with implants and implant prostheses. J Prosthet Dent. 2003 Aug;90(2):121-32. doi: 10.1016/S0022-3913(03)00212-9.

  PMID: 12886205 BACKGROUND

• Pjetursson BE, Thoma D, Jung R, Zwahlen M, Zembic A. A systematic review of the survival and complication rates of implant-supported fixed dental prostheses (FDPs) after a mean observation period of at least 5 years. Clin Oral Implants Res. 2012 Oct;23 Suppl 6:22-38. doi: 10.1111/j.1600-0501.2012.02546.x.

  PMID: 23062125 BACKGROUND

• Papaspyridakos P, Chen CJ, Gallucci GO, Doukoudakis A, Weber HP, Chronopoulos V. Accuracy of implant impressions for partially and completely edentulous patients: a systematic review. Int J Oral Maxillofac Implants. 2014 Jul-Aug;29(4):836-45. doi: 10.11607/jomi.3625.

  PMID: 25032763 BACKGROUND

• Papaspyridakos P, Gallucci GO, Chen CJ, Hanssen S, Naert I, Vandenberghe B. Digital versus conventional implant impressions for edentulous patients: accuracy outcomes. Clin Oral Implants Res. 2016 Apr;27(4):465-72. doi: 10.1111/clr.12567. Epub 2015 Feb 13.

  PMID: 25682892 BACKGROUND

• Perez-Davidi M, Levit M, Walter O, Eilat Y, Rosenfeld P. Clinical accuracy outcomes of splinted and nonsplinted implant impression methods in dental residency settings. Quintessence Int. 2016;47(10):843-852. doi: 10.3290/j.qi.a36323.

  PMID: 27284582 BACKGROUND

• Miyoshi K, Tanaka S, Yokoyama S, Sanda M, Baba K. Effects of different types of intraoral scanners and scanning ranges on the precision of digital implant impressions in edentulous maxilla: An in vitro study. Clin Oral Implants Res. 2020 Jan;31(1):74-83. doi: 10.1111/clr.13548. Epub 2019 Oct 28.

  PMID: 31608509 BACKGROUND

• Nagata K, Fuchigami K, Okuhama Y, Wakamori K, Tsuruoka H, Nakashizu T, Hoshi N, Atsumi M, Kimoto K, Kawana H. Comparison of digital and silicone impressions for single-tooth implants and two- and three-unit implants for a free-end edentulous saddle. BMC Oral Health. 2021 Sep 23;21(1):464. doi: 10.1186/s12903-021-01836-1.

  PMID: 34556111 BACKGROUND

• Revell G, Simon B, Mennito A, Evans ZP, Renne W, Ludlow M, Vag J. Evaluation of complete-arch implant scanning with 5 different intraoral scanners in terms of trueness and operator experience. J Prosthet Dent. 2022 Oct;128(4):632-638. doi: 10.1016/j.prosdent.2021.01.013. Epub 2021 Apr 6.

  PMID: 33832761 BACKGROUND

• Tan MY, Yee SHX, Wong KM, Tan YH, Tan KBC. Comparison of Three-Dimensional Accuracy of Digital and Conventional Implant Impressions: Effect of Interimplant Distance in an Edentulous Arch. Int J Oral Maxillofac Implants. 2019 March/April;34(2):366-380. doi: 10.11607/jomi.6855. Epub 2018 Dec 5.

  PMID: 30521661 BACKGROUND

• Lyu M, Di P, Lin Y, Jiang X. Accuracy of impressions for multiple implants: A comparative study of digital and conventional techniques. J Prosthet Dent. 2022 Nov;128(5):1017-1023. doi: 10.1016/j.prosdent.2021.01.016. Epub 2021 Feb 25.

  PMID: 33640093 BACKGROUND

• Thanasrisuebwong P, Kulchotirat T, Anunmana C. Effects of inter-implant distance on the accuracy of intraoral scanner: An in vitro study. J Adv Prosthodont. 2021 Apr;13(2):107-116. doi: 10.4047/jap.2021.13.2.107. Epub 2021 Apr 27.

  PMID: 34025959 BACKGROUND

• Resende CCD, Barbosa TAQ, Moura GF, Tavares LDN, Rizzante FAP, George FM, Neves FDD, Mendonca G. Influence of operator experience, scanner type, and scan size on 3D scans. J Prosthet Dent. 2021 Feb;125(2):294-299. doi: 10.1016/j.prosdent.2019.12.011. Epub 2020 Feb 27.

  PMID: 32115221 BACKGROUND

• Huang R, Liu Y, Huang B, Zhang C, Chen Z, Li Z. Improved scanning accuracy with newly designed scan bodies: An in vitro study comparing digital versus conventional impression techniques for complete-arch implant rehabilitation. Clin Oral Implants Res. 2020 Jul;31(7):625-633. doi: 10.1111/clr.13598. Epub 2020 Apr 3.

  PMID: 32181919 BACKGROUND

• Huang R, Liu Y, Huang B, Zhou F, Chen Z, Li Z. Improved accuracy of digital implant impressions with newly designed scan bodies: an in vivo evaluation in beagle dogs. BMC Oral Health. 2021 Dec 7;21(1):623. doi: 10.1186/s12903-021-01986-2.

  PMID: 34876122 BACKGROUND

• Iturrate M, Eguiraun H, Solaberrieta E. Accuracy of digital impressions for implant-supported complete-arch prosthesis, using an auxiliary geometry part-An in vitro study. Clin Oral Implants Res. 2019 Dec;30(12):1250-1258. doi: 10.1111/clr.13549. Epub 2019 Oct 28.

  PMID: 31610069 BACKGROUND

• Mizumoto RM, Yilmaz B, McGlumphy EA Jr, Seidt J, Johnston WM. Accuracy of different digital scanning techniques and scan bodies for complete-arch implant-supported prostheses. J Prosthet Dent. 2020 Jan;123(1):96-104. doi: 10.1016/j.prosdent.2019.01.003. Epub 2019 Apr 27.

  PMID: 31040026 BACKGROUND

• Dohiem MM, Abdelaziz MS, Abdalla MF, Fawzy AM. Digital assessment of the accuracy of implant impression techniques in free end saddle partially edentulous patients. A controlled clinical trial. BMC Oral Health. 2022 Nov 12;22(1):486. doi: 10.1186/s12903-022-02505-7.

  PMID: 36371189 BACKGROUND

Study Officials

• Ingy A. Talaat, PHD

  Ain Shams Univeristy

  STUDY DIRECTOR

• Noha H. Nawar, PHD

  Ain Shams Univeristy

  STUDY DIRECTOR

• Omar A. El-Sadat, PHD

  Ain Shams Univeristy

  STUDY DIRECTOR

• Omnia M. Refai, PHD

  Ain Shams Univeristy

  STUDY DIRECTOR

Central Study Contacts

Kirollos S. Shanoudy, PHD candidate

CONTACT

01280180780; KirollosShanoudy@dent.asu.edu.eg

Omnia M. Refai, PHD

CONTACT

01202420046; omnia_refaie@dent.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Lecturer

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09