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PassivityNCT04848207

Effect of Open Tray Versus Digital Impressions on the Passivity and Prosthetic Complications of Full Arch Screw-retained Prosthesis

A study testing Digital impression technique and Open tray impression technique in people with Passivity and Prosthetic Complications, run by Cairo 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 The sponsor has not verified this record for over two years, so it may be out of date.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 importance of this trial lies in testing if intraoral digital impressions will increase the accuracy of impressions of full arch implant cases over conventional impression techniques thus improving the passivity of full arch screw retained prosthesis and decreasing the prosthetic complications in turn. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Passivity, Prosthetic Complications
What is being tested?
Digital impression technique and Open tray impression technique
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
No sites listed yet
Study dates
Jun 2021to Dec 2022
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

  • Completely edentulous patients with sufficient inter-arch space to receive fixed prosthesis (Crown height space 9-15 mm per arch)
  • Completely edentulous patients with 4 implants in mandible and/ or 6 implants in maxilla
  • sufficient bone volume for implant placement without graft a confirmed by CBCT
  • adequate zone of keratinized mucosa ( > 2mm width)
  • All genders
  • Acceptable oral hygiene
  • Cooperative patients
  • Controlled systemic diseases ( Diabetes, hypertension)

Who cannot join

  • Completely edentulous patients with sufficient inter-arch space to receive fixed prosthesis (Crown height space 9-15 mm per arch)
  • Completely edentulous patients with 4 implants in mandible and/ or 6 implants in maxilla
  • sufficient bone volume for implant placement without graft a confirmed by CBCT
  • adequate zone of keratinized mucosa ( > 2mm width)
  • All genders
  • Acceptable oral hygiene
  • Cooperative patients
  • Controlled systemic diseases ( Diabetes, hypertension)

About this study

Official title: Effect of Open Tray Versus Digital Impressions on the Passivity and Prosthetic Complications of Full Arch Screw-retained Prosthesis - A Randomized Control Trial Study

The importance of this trial lies in testing if intraoral digital impressions will increase the accuracy of impressions of full arch implant cases over conventional impression techniques thus improving the passivity of full arch screw retained prosthesis and decreasing the prosthetic complications in turn.

Read the detailed description

In this study intraoral digital impressions will be used for scanning full arch implant cases to minimize the variables in the conventional technique, finally the study will investigate if the intraoral digital impressions will increase the accuracy of impressions of full arch implant cases thus improving the passivity and decreasing prosthetic complications of screw retained prosthesis for a long-term success compared to open tray impression technique.

Primary outcome will be evaluation of the passivity of PMMA (Polymethyl methacrylate ) try-in , while secondary outcomes will be detecting prosthetic complications (screw loosening , prosthesis fracture) and treatment time for both groups.

Eligibility criteria:

Inclusion criteria:

  • Completely edentulous patients with sufficient inter-arch space to receive fixed prosthesis (Crown height space 9-15 mm per arch)
  • Completely edentulous patients with 4 implants in mandible and/ or 6 implants in maxilla
  • sufficient bone volume for implant placement without graft a confirmed by CBCT
  • adequate zone of keratinized mucosa ( > 2mm width)
  • All genders
  • Acceptable oral hygiene
  • Cooperative patients
  • Controlled systemic diseases ( Diabetes, hypertension)

Exclusion criteria:

  • Completely edentulous patients with insufficient inter-arch space to receive fixed prosthesis ( Crown height space lesser than 9mm per arch)
  • Insufficient bone volume for implant placement
  • Completely edentulous patients with in-adequate zone of keratinized mucosa (< 2mm).
  • Un cooperative patients
  • Poor oral hygiene
  • Uncontrolled diabetic patients( Diabetes, hypertension)

Interventions:

Completely edentulous patients that have received dental implants and ready to start prosthetic steps of full arch screw retained prosthesis will be recruited and randomly divided into two groups.

Group 1 ( control group):

  • Primary impression will be taken followed by customization of open special trays for each patient.
  • Transfer copings will be screwed to the multiunit abutments on the existing implants, and splinted together using pre-cured printed resin splinting framework that will be fixed to the copings using flowable composite and one step impression technique using putty and light addition silicon will be made . Implant analogs will be attached to the transfer copings and pouring of the impression will be done using dental stone.
  • Bite registration will be done followed by mounting of stone casts on the articulator.
  • Patient's stone models and bite will be scanned using desktop scanner and the trial PMMA bridge will be designed and 3D-printed as a verification jig to evaluate the accuracy of the taken impression.
  • Passivity of the trial PMMA bridge will be evaluated on patients intra-orally using single screw test, peri-apical radiographs and Screw resistance parameter (SR parameter).
  • Regarding the final prosthesis a framework will be designed on the patient's scan and milled from (PEEK blocks) , finished and polished then layered by (pink composite ) and (composite teeth) will be used.
  • Final prosthesis will be delivered to the patient and treatment time will be measured by the number of visits starting from impression taking session till delivery session.
  • Follow up of the patients will be done every at 3 and 6 months to check if there are any prosthetic complications (screw loosening or fracture). while in Group 2 ( intervention group):
  • Intra-oral scanner will be used in the study to take a digital impression for the implants.
  • 3D printed generic Scan bodies with unified shape and length replacing the traditional transfer copings will be press fitted on the trans-mucosal abutments and pickup cylinders that are screwed on the implants to capture their position and intra-oral scanning will be done.
  • With scan bodies in place, bite will be registered where, in case of completely edentulous upper and lower arches a 3D printed centric holding device will be used to fix the vertical dimension at the desired height and the intra-oral scanner will capture the bite at this position, but in case of a completely edentulous arch opposed by dentulous arch , a green stick jig will be customized anteriorly to hold vertical dimension at the desired height and intra-oral scanner will be used to record the bite bilaterally.
  • The STL file of the captured scan will be 3D-printed into a resin model with negative places replicating the analogues design in which the digital analogues will be seated.
  • The trial PMMA bridge will be designed on the implants scan then 3D- printed, to be fitted on the resin model having digital analogues in place.
  • Passivity of the trial PMMA bridge will be evaluated on patients the same way as group 1.
  • The final prosthesis a framework will be designed and milled as in group 1 then delivered to the patient outcomes:
  • Passivity of PMMA tryin: will be measured by Single screw test, Periapical radiograph, Screw resistance parameter (SR parameter) at PMMA tryin visit (2nd visit after impressions Instantly).
  • Prosthetic complications (screw loosening , prosthesis fracture) : will be measured by Clinical examination at 3, 6 months of delivery of final prosthesis.
  • Treatment time : will be measured by Number of visits at the last visit.
Being tested
Digital impression technique, Open tray impression technique

What participants receive

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

  • Digital impression techniqueDevice

    3D printed generic Scan bodies with unified shape and length replacing the traditional transfer copings will be press fitted on the trans-mucosal abutments and pickup cylinders that are screwed on the implants to capture their position and intra-oral scanning will be done.

  • Open tray impression techniqueOther

    Transfer copings will be screwed to the multiunit abutments on the existing implants, and splinted together using pre-cured printed resin splinting framework that will be fixed to the copings using flowable composite .

    A one step impression technique using putty and light addition silicon will be made, where light impression material will be injected all around transfer copings and putty silicon will be loaded in tray and then will be seated intra-orally making sure to fully expose the screws of transfer copings through the impression material.

Study groups in NCT04848207
Study groupRoleWhat they receive
Digital impression techniqueOther- 3D printed generic Scan bodies with unified shape and length replacing the traditional transfer copings will be press fitted on the trans-mucosal abutments and pickup cylinders that are screwed on the implants to capture their position and intra-oral scanning will be done.
Receives: Device: Digital impression technique
Open tray impression techniqueOther* Transfer copings will be screwed to the multiunit abutments on the existing implants, and splinted together using pre-cured printed resin splinting framework that will be fixed to the copings using flowable composite . * A one step impression technique using putty and light addition silicon will be made, where light impression material will be injected all around transfer copings and putty silicon will be loaded in tray and then will be seated intra-orally making sure to fully expose the screws of transfer copings through the impression material.
Receives: Other: Open tray impression technique

What is being measured

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

  1. Passivity of seating of PolyMethylMethAcrylate (PMMA) tryin prosthesis

    the screw retained prosthesis can be considered passive when it does not generate static loads and strains within the prosthesis or in the surrounding bone structure measured using Single screw test (measuring unit : binary - yes/No)

    Measured: 3-4 months after implants placement after final impressions for implants

  2. Passivity of seating of PolyMethylMethAcrylate (PMMA) tryin prosthesis

    the screw retained prosthesis can be considered passive when it does not generate static loads and strains within the prosthesis or in the surrounding bone structure measured using

    -Periapical radiograph ( measuring unit : binary- Yes/No)

    Measured: 3-4 months after implants placement after final impressions for implants

  3. Passivity of seating of PolyMethylMethAcrylate (PMMA) tryin prosthesis

    the screw retained prosthesis can be considered passive when it does not generate static loads and strains within the prosthesis or in the surrounding bone structure measured using

    • Screw resistance parameter (Measuring unit: Difference of rotation angles in passive and non- passive situations)

    Measured: 3-4 months after implants placement after final impressions for implants

Secondary outcomes (2)
  1. Prosthetic complications including screw loosening and prosthesis fracture

    screw loosening , prosthesis fracture will be assessed by clinical examination (measuring unit : number of times )

    Measured: At 3, 6 months after delivery of final prosthesis

  2. Treatment time

    Number of visits

    Measured: 5-6 months after implants placement ( at the last visit )

Timeline

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

  1. First posted19 Apr 2021
  2. Study startJun 2021 (estimated)
  3. Primary completionDec 2022 (estimated)
  4. Study completionDec 2022 (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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
92 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04848207
Sponsor's protocol ID
PRO 6-2-2
Status last verified
Apr 2021
First submitted
6 Apr 2021
Last updated
19 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Digital impression technique and Open tray impression technique in people with Passivity and Prosthetic Complications, run by Cairo 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 8 inclusion and 8 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 Apr 2021. 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?

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?

Passivity of seating of PolyMethylMethAcrylate (PMMA) tryin prosthesis (time frame: 3-4 months after implants placement after final impressions for implants). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 Apr 2021.

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