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

NCT04848207 | Unknown DMC

• 1 other identifier: PRO 6-2-2
• Study Type: interventional
• Target: 92
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Passivity; Prosthetic Complications

Outcome Measures

Primary Outcomes (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 Single screw test (measuring unit : binary - yes/No)

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

• 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)

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

• 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)

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

Secondary Outcomes (2)

• Prosthetic complications including screw loosening and prosthesis fracture

  At 3, 6 months after delivery of final prosthesis

• Treatment time

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

Study Arms (2)

Digital impression technique

OTHER

\- 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.

Device: Digital impression technique

Open tray impression technique

OTHER

* 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.

Other: Open tray impression technique

Interventions

Digital impression technique DEVICE

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.

Digital impression technique

Open tray impression technique OTHER

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.

Open tray impression technique

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cairo University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc faculty of Dentistry, Cairo university (2019)

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 19, 2021
• Study Start: June 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share