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Dental Impression TechniqueNCT06592066

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

A study testing Digital Impression by using Intraoral Scanning of Scan Bodies, Digital Impression by using Intraoral Scanning of Scan Bodies with Prefabricated Landmarks and Splinted Open Top Tay Conventional Impression Technique in people with Dental Impression Technique, run by Ain Shams University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 70 years
Conditions the study is for
Dental Impression Technique
What is being tested?
Digital Impression by using Intraoral Scanning of Scan Bodies, Digital Impression by using Intraoral Scanning of Scan Bodies with Prefabricated Landmarks and Splinted Open Top Tay Conventional Impression Technique
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
No sites listed yet
Study dates
Sep 2024to Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet.

Kirollos S. Shanoudy, PHD candidate contact

01280180780

KirollosShanoudy@dent.asu.edu.eg

About this study

Official title: Accuracy of Digital Intraoral Scanning With and Without Prefabricated Landmarks Versus Conventional Impression Technique for Mandibular Implant Supported Full-Arch Prosthesis

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.

Read the detailed description

Implant-supported full arch dental prostheses are crucial and reliable alternatives for individuals with missing teeth in their jaws. The initial phase in the production of implant-supported prostheses involves the impression-taking process. Inaccurate impressions can result in a misfit between the prosthesis and implant abutment, potentially causing both mechanical and biological complications that can adversely affect the long-term viability of the implants. Therefore, the precision of impressions is of utmost importance, particularly for prostheses supported by multiple implants.

The conventional approach to obtaining impressions for multiple implants involves the use of an open-tray technique, widely adopted in dental practice. In this method, impression copings are connected to prevent rotational movements, making it a preferable choice compared to the non-splinting technique. Nevertheless, this procedure is complex, less efficient, and demands considerable clinical expertise. It is advised for use by experienced dentists, as those lacking experience have shown a notably higher rate of unsuccessful outcomes when employing the splinting technique.6 Additionally, various factors, such as patients' pharyngeal reflex and the potential deformation of impression materials, can influence the accuracy of implant impressions in the conventional workflow.

With the advancement of computer-aided design/computer-aided manufacturing (CAD/CAM) and digital technologies, the intraoral scanner (IOS) has gained popularity for capturing implant positions. In clinical practice, IOSs are valued for their comfort, efficiency, and practicality. However, it's important to note that IOSs cannot completely replace traditional methods. When it comes to implant-supported fixed dental prostheses, intraoral scanners can effectively be used for single- and three-unit implant scanning.

In a study from 2020, Revell et al. recommended specific scanners, such as Primescan, for complete-arch implant impressions due to their low deviation values at the implant platform level. Nevertheless, the accuracy of older models of intraoral scanners may not be reliable when scanning edentulous spaces with long inter-implant distances or fully edentulous jaws, particularly in the hands of inexperienced operators.

Previous research has introduced custom-designed scan bodies featuring an extensional structure to achieve dependable digital full-arch implant impressions. Typically, these platforms necessitate the use of custom-made scan bodies or a secondary scan to obtain mucosal information. In this context, this study is conducted to present newly designed prefabricated landmarks between the scan bodies to offer a solution for digital scanning of a mandibular full-arch implant. Therefore, the aim of this study is to evaluate and compare the accuracy of digital intraoral scanning with or without prefabricated landmarks to conventional impression techniques in mandibular full-arch implant cases.

The null hypothesis posits that there would be no significant difference in accuracy between digital intraoral scanning with or without prefabricated landmarks between scan bodies and conventional impression techniques.

Being tested
Digital Impression by using Intraoral Scanning of Scan Bodies, Digital Impression by using Intraoral Scanning of Scan Bodies with Prefabricated Landmarks, Splinted Open Top Tay Conventional Impression Technique

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Digital Impression by using Intraoral Scanning of Scan BodiesDevice

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

  • Digital Impression by using Intraoral Scanning of Scan Bodies with Prefabricated LandmarksDevice

    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.

  • Splinted Open Top Tay Conventional Impression TechniqueDevice

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

Study groups in NCT06592066
Study groupRoleWhat they receive
Splinted Conventional Impression TechniqueActive comparatorSplinted open tray conventional impression technique will be used for the mandibular full-arch implants, utilizing medium body impression material.
Receives: Device: Splinted Open Top Tay Conventional Impression Technique
Digital impression technique with scan bodiesExperimentalDigital impression technique will be employed for mandibular full-arch implants, using intraoral scanning with scan bodies to capture the implant positions.
Receives: Device: Digital Impression by using Intraoral Scanning of Scan Bodies
Digital impression technique with scan bodies with Prefabricated LandmarksExperimentalDigital impression technique will be employed for mandibular full-arch implants, using intraoral scanning with scan bodies with prefabricated landmarks to capture the implant positions.
Receives: Device: Digital Impression by using Intraoral Scanning of Scan Bodies with Prefabricated Landmarks

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study startSep 2024 (estimated)
  3. Primary completionSep 2025 (estimated)
  4. Study completionOct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06592066
Sponsor's protocol ID
FDASU-Rec ID022403
Status last verified
Sep 2024
First submitted
9 Sep 2024
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 23311617
  • 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.

    PubMed 12886205
  • 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.

    PubMed 23062125
  • 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.

    PubMed 25032763
  • 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.

    PubMed 25682892
  • 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.

    PubMed 27284582
  • 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.

    PubMed 31608509
  • 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.

    PubMed 34556111
  • 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.

    PubMed 33832761
  • 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.

    PubMed 30521661
  • 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.

    PubMed 33640093
  • 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.

    PubMed 34025959
  • 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.

    PubMed 32115221
  • 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.

    PubMed 32181919
  • 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.

    PubMed 34876122

Questions about this trial

What is this clinical trial studying?

A study testing Digital Impression by using Intraoral Scanning of Scan Bodies, Digital Impression by using Intraoral Scanning of Scan Bodies with Prefabricated Landmarks and Splinted Open Top Tay Conventional Impression Technique in people with Dental Impression Technique, run by Ain Shams University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kirollos S. Shanoudy, PHD candidate (01280180780, KirollosShanoudy@dent.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The accuracy of digital intraoral scanning of full-arch mandibular implants. (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06592066, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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