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Edentulous JawNCT03992300

Comparison of Full-arch Implant-supported Frameworks From an Intraoral Scanning or From a Conventional Impression

A study testing Clinical adjustment in people with Edentulous Jaw, run by Universitat Internacional de Catalunya at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Purpose: To determine if adjustment of full-arch zirconia frameworks processed on a model obtained with an intraoral scanner and an auxiliary device is not inferior to that of identical frameworks obtained from an elastomeric impression. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Edentulous Jaw
What is being tested?
Clinical adjustment
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteSpain
Study dates
28 May 2019to 30 Sep 2019
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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • ·Patients with four or more implants already osseo-integrated ready to rehabilitate with a full-arch implant-supported framework of 10 or more units. ·Upper or lower jaw.

Who cannot join

  • Implants not suitable for multiunit abutments.
  • More than six implants.
  • Peri-implantitis present in any implant.
  • Need of a removable prosthesis.
  • Patients unable to understand the purpose of the study.
  • Patients with a restorative space higher than 15 milimiters.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Clinica Universitaria d'Odontologia

    Sant Cugat Del Vallés, Barcelona, 08195

Other trials in Spain

About this study

Official title: Comparison of Accuracy and Timing Parameter of Digital and Conventional Impression Techniques on Fully Edentulous Jaws: an in Vivo Study

Purpose: To determine if adjustment of full-arch zirconia frameworks processed on a model obtained with an intraoral scanner and an auxiliary device is not inferior to that of identical frameworks obtained from an elastomeric impression.

Materials and methods: Eight consecutive patients ready for a full-arch rehabilitation on already osseointegrated implants were selected. Two sets of impressions were taken, one open tray with polyether and splinted impression copings and a second one with an intraoral scanner. A verification plaster jig was used for the elastomeric impression and a prefabricated auxiliary device was used to adjust the optical intraoral impressions. Two full-zirconia frameworks with the same design were processed and tested on the patient by two independent calibrated operators. Accuracy of both frameworks was measured by calibrated blinded operators, who determined tactile adjustment, Sheffield test, radiographic adjustment, and screwing torque. Overall perception of adjustment was used to determine the better framework to be delivered to the patient.

Hº: Frameworks obtained from an impression taken with an intraoral scanner are not inferior in accuracy to those obtained from a conventional elastomeric impression

Read the detailed description

Eight consecutive patients ready for a full-arch rehabilitation on previously osseointegrated implants, and who had received an immediately loaded prosthesis, were selected. All implants had multiunit abutments placed on top. Cases from 4 to 6 implants were accepted, either upper or lower arches. Three sets of impressions were taken to each patient:

Conventional impression:

Open tray impression copings were screwed on top of all implants in the arch using a torque wrench set at 10 N/cm. Impression copings were splinted by means of Triad Gel clear resin, with an at least 3mm diameter in the resin connectors. Once the resin was photo-polymerized a cut was done in the centre of each connection with a 0.3 mm bur, to eliminate possible stress in the structure, and then it was splinted again with a drop of Triad Gel in each cut. A polyether impression was taken by means of a perforated plastic tray, and a master model was fabricated following the manufacturer's instructions. A plaster verification jig was fabricated on the model. After one week the patient came to the dental clinic where vertical dimension of occlusion was determined and the plaster key was screwed in the patient mouth to check passivity. In case the key had been fractured, a new impression would have been taken, and if not, final prosthesis could be processed.

Optical impression:

An impression of the antagonist and an impression of the edentulous arch with the healing abutments in place were taken by means of an optical scanner following the manufacturers protocol. The position of the implants was marked in the working standard tessellation language (STL) model, and the software cut a circle on top of those areas. The files were copied, and two datasets were obtained.

Scan-bodies were placed on top of each multiunit abutment, the first STL dataset was open and a second impression was taken, so that the scan-bodies were positioned on the working file.

Scan-bodies were then removed from the patient mouth, and temporary copings were placed on top of each multiunit abutment. A MedicalFit device was selected, and holes were drilled in the position of the implants until it fitted on top of all the cylinders. Cylinders were then splinted to MedicalFit device by means of Triad Gel clear. The device was then removed from the patient mouth and scan implant replicas were placed at the bottom of the metal cylinders. Finally, the device with the scan implant replicas was scanned with an intraoral optical scanner.

The following set of pictures were taken: Rest position, maximum smile (with the scan bodies placed in the mouth), front with retractors (with the scan bodies), and 45º with retractors (also with the scan bodies in place).

All pictures and STL datasets were sent to the dental technician to produce a temporary structure. The STL dataset from the scanning of Medicalfit device used was adjusted to the original STL dataset of the device in the library, and then superimposed to the dataset of the scan-bodies received from us, to allow repositioning of the scan-bodies and to correct possible discrepancies during the intraoral scanning process.

A temporary polymethylmethacrylate (PMMA) framework was delivered by the dental lab and tried in the patient mouth. Corrections were done to adjust occlusion, gingival contour and esthetic parameters where needed. Once esthetic parameters and occlusal scheme were considered correct, a new intraoral scanning was taken with the temporary framework in place. In case changes were done in the gingival contour, scanning of the gingival aspect of the PMMA framework was also done. The PMMA temporary was then left in the patient mouth.

Three pictures were taken with the PMMA framework placed in the mouth: Front full face at rest, front full-face smiling, front full face with separators and full face smiling at 45º.

Clinical adjustment assessment:

After one week two sets of the final prosthesis in full-zirconia were sent from the dental lab, one processed with conventional models and the second fully digital. Both sets were tested in the patient mouth by two calibrated blinded independent operators.

Misfit should be ideally measured in terms smaller than 10 microns, but clinical adjustment is difficult to assess using conventional or quantitative methods. In this research adjustment was assessed following four criteria: passivity in the insertion of the screws, tactile sensation, radiographs and screwing torque:

  1. A Visual Analogue Scale (VAS) was used to assess the perception of passivity in the insertion of the prosthodontic screws. A ten centimeters line will be shown to the observer. One side of the line represents "perfect passivity", and the other "no passive at all". The observer will mark his passivity perception on the line between the two endpoints. The distance between "no passivity at all" and the mark will defines the passivity perception.
  2. Examination of the marginal fit with an exploratory probe (#23/3 explorer) under 3,8x magnification. Three possible scores were possible: 0 (no gap perceived when probing), 1 (perception of the gap without entering it) and 2 (the tip of the explorer clearly entered the gap).
  3. Periapical radiographs were taken with a positioning system to evaluate possible gaps. Five possible scores were possible from 1 to 5, being 1 no gap and increasing 0.15 mm each score until reaching 0.60 mm in score 5.
  4. Digital photographs were taken with a 105 mm macro lens. The pictures were calibrated with the known height of the framework and the gap was measured. Four possible scores were possible, being 1 no gap and increasing 0.25 mm each score until reaching 0.75 mm in score 5.
  5. Screwing torque on each abutment was measured with the app software from Ichiropro motor (BienAir, Bienne, Switzerland). All screws were hand screwed and then all but the most distal right were unscrewed. Torque was set at 15 N/cm and speed at 5 rpm. The most right distal screw was tightened first, and then the rest of the screws were tightened starting at the most mesial left, following to the most distal left, and from that to the next neighbor implant until all screws were tightened. The torque-time signature was studied in every screw to determine if the torque started to grow just at the end of the tightening or throughout the process. Three scores were possible: 1 for linear value with a fast increase at end of the tightening, 2 for soft continuous growth with a steeper increase at the end, 3 for steep increase at the beginning of tightening.

Once the assessment of the two frameworks was completed, the framework with better adjustment will be placed in the patient, after assessing the presence of correct occlusion, phonetics and esthetic parameters. The second set will be packed and delivered to the patient as a possible replacement in case of problems in the future.

Conditions
Edentulous Jaw
Being tested
Clinical adjustment
Medical subject headings
Jaw, Edentulous

What participants receive

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

  • Clinical adjustmentDevice

    Accuracy of the framework is checked in the patient mouth by tactile perception, screwing torque, Sheffield test and radiography.

Study groups in NCT03992300
Study groupRoleWhat they receive
Intraoral scanningExperimentalAn intraoral scanning is taken. An auxiliary device is used to achieve better accuracy. A zirconia framework is produced
Receives: Device: Clinical adjustment
Conventional scanningActive comparatorA conventional elastomeric impression is taken and a zirconia framework is produced
Receives: Device: Clinical adjustment

What is being measured

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

  1. Accuracy of the framework

    Overall perception of adjustment of the two frameworks

    Measured: one day

Secondary outcomes (4)
  1. Perception of the passivity

    A Visual Analogue Scale (VAS) will be used to assess the perception of passivity in the insertion of the prosthodontic screws. A ten centimeters line will be shown to the observer. One side of the line represents "perfect passivity", and the other "no passivity at all". The observer will mark his passivity perception on the line between the two endpoints. The distance between "no passivity at all" and the mark will define the passivity perception.

    Measured: 1 day

  2. Optical adjustment

    Examination of the marginal fit with an exploratory probe (#23/3 explorer) under 3,8x magnification. Three possible scores were possible: 0 (no gap perceived when probing), 1 (perception of the gap without entering it) and 2 (the tip of the explorer clearly entered the gap).

    Measured: 1 day

  3. Radiographic adjustment

    Periapical radiographs will be taken with a positioning system to evaluate possible gaps. Five possible scores will be possible from 1 to 5, being 1 no gap and increasing 0.15mm each score until reaching 0.60mm in score 5.

    Measured: 1 day

  4. Screwing torque

    Screwing torque in each abutment will be measured by means of Ichiropro® motor. The torque/angle signature will be registered and three possible scores will be possible: 1 for linear value with a fast increase at end of the tightening, 2 for soft continuous growth with a steeper increase at the end, 3 for steep increase at the beginning of tightening.

    Measured: 1 day

Timeline

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

  1. First posted20 Jun 2019
  2. Study start28 May 2019
  3. Primary completion30 Sep 2019
  4. Study completion30 Sep 2019

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
Device feasibility
Allocation
Non-randomised
Intervention model
Crossover
Model description
Two frameworks with the same design obtained from two different models (intraoral scanning and conventional impression) are processed and tested in every patient
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03992300
Sponsor's protocol ID
REST-ECT-2017-03
Status last verified
Jun 2019
First submitted
17 Jun 2019
Last updated
16 Dec 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We plan to publish the data in a paper

Publications

  • 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.

    PubMed 18922257
  • al-Turki LE, Chai J, Lautenschlager EP, Hutten MC. Changes in prosthetic screw stability because of misfit of implant-supported prostheses. Int J Prosthodont. 2002 Jan-Feb;15(1):38-42.

    PubMed 11887597
  • Jansen VK, Conrads G, Richter EJ. Microbial leakage and marginal fit of the implant-abutment interface. Int J Oral Maxillofac Implants. 1997 Jul-Aug;12(4):527-40.

    PubMed 9274082
  • Millington ND, Leung T. Inaccurate fit of implant superstructures. Part 1: Stresses generated on the superstructure relative to the size of fit discrepancy. Int J Prosthodont. 1995 Nov-Dec;8(6):511-6.

    PubMed 8595110
  • Sahin S, Cehreli MC. The significance of passive framework fit in implant prosthodontics: current status. Implant Dent. 2001;10(2):85-92. doi: 10.1097/00008505-200104000-00003.

    PubMed 11450418
  • Abduo J, Bennani V, Waddell N, Lyons K, Swain M. Assessing the fit of implant fixed prostheses: a critical review. Int J Oral Maxillofac Implants. 2010 May-Jun;25(3):506-15.

    PubMed 20556249
  • Katsoulis J, Takeichi T, Sol Gaviria A, Peter L, Katsoulis K. Misfit of implant prostheses and its impact on clinical outcomes. Definition, assessment and a systematic review of the literature. Eur J Oral Implantol. 2017;10 Suppl 1:121-138.

    PubMed 28944373
  • Assif D, Marshak B, Schmidt A. Accuracy of implant impression techniques. Int J Oral Maxillofac Implants. 1996 Mar-Apr;11(2):216-22.

    PubMed 8666454
  • Al-Meraikhi H, Yilmaz B, McGlumphy E, Brantley W, Johnston WM. In vitro fit of CAD-CAM complete arch screw-retained titanium and zirconia implant prostheses fabricated on 4 implants. J Prosthet Dent. 2018 Mar;119(3):409-416. doi: 10.1016/j.prosdent.2017.04.023. Epub 2017 Jul 15.

    PubMed 28720339
  • Jemt T. Failures and complications in 391 consecutively inserted fixed prostheses supported by Branemark implants in edentulous jaws: a study of treatment from the time of prosthesis placement to the first annual checkup. Int J Oral Maxillofac Implants. 1991 Fall;6(3):270-6.

    PubMed 1813395
  • Klineberg IJ, Murray GM. Design of superstructures for osseointegrated fixtures. Swed Dent J Suppl. 1985;28:63-9. No abstract available.

    PubMed 3904064
  • Gibbs SB, Versluis A, Tantbirojn D, Ahuja S. Comparison of polymerization shrinkage of pattern resins. J Prosthet Dent. 2014 Aug;112(2):293-8. doi: 10.1016/j.prosdent.2014.02.006. Epub 2014 Apr 14.

    PubMed 24726587
  • Papaspyridakos P, Lal K. Computer-assisted design/computer-assisted manufacturing zirconia implant fixed complete prostheses: clinical results and technical complications up to 4 years of function. Clin Oral Implants Res. 2013 Jun;24(6):659-65. doi: 10.1111/j.1600-0501.2012.02447.x. Epub 2012 Mar 13.

    PubMed 22413889
  • Kan JY, Rungcharassaeng K, Bohsali K, Goodacre CJ, Lang BR. Clinical methods for evaluating implant framework fit. J Prosthet Dent. 1999 Jan;81(1):7-13. doi: 10.1016/s0022-3913(99)70229-5.

    PubMed 9878969
  • Ebadian B, Rismanchian M, Dastgheib B, Bajoghli F. Effect of different impression materials and techniques on the dimensional accuracy of implant definitive casts. Dent Res J (Isfahan). 2015 Mar-Apr;12(2):136-43.

    PubMed 25878678

Questions about this trial

What is this clinical trial studying?

A study testing Clinical adjustment in people with Edentulous Jaw, run by Universitat Internacional de Catalunya at 1 site in Spain.

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 6 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: finished, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accuracy of the framework (time frame: one day). 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 NCT03992300, which also lists 31 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 16 Dec 2019.

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