NCT06281002

Brief Summary

The goal of this clinical trial study is to evaluate the accuracy of the full digital workflow for four-implant, screw-retained mandibular hybrid prostheses in patients with completely edentulous mandible.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

6 months

First QC Date

February 20, 2024

Last Update Submit

March 3, 2024

Conditions

DentureComplete Edentulism

Keywords

Intraoral scanningDigital implant modelsEdentulous mandibleScrew retained prosthesisGeometric scanning aids

Outcome Measures

Primary Outcomes (1)

  • Trueness of full arch digital scans when additional geometric scanning aids are coupled with the scan bodies.

    The optical impressions will be obtained by an intraoral scanner while the scan abutments are coupled with 3D geometric scanning aids and seated in positions. special digital software will be used to compare the trueness of virtual implant positions in the obtained digital scan STL files to the digitized reference positions in the patients' digitized conventional stone model

    2 months

Secondary Outcomes (1)

  • Trueness of the generated 3D-printed digital implant models.

    2 months

Study Arms (2)

conventional physical impressions

ACTIVE COMPARATOR

Nine physical open tray impressions will be poured into a hard dental stone to obtain nine definitive implant casts with conventional implant analogs. The impressions will be scanned to provide a gold standard reference STL files.

Device: conventional impression stone casts digitization

optical impressions with additional geometric scanning aids coupled with the scan bodies

EXPERIMENTAL

Nine optical impressions will be obtained while additional geometric scanning aids are coupled with the scan bodies to get nine CAD/CAM 3D-printed polymer casts with digital implant analogs.

Device: digital scanning with coupled scanning aiding deviceDevice: Digital Implant Model assessment of accuracy

Interventions

conventional impression stone casts digitizationDEVICE

Nine conventional physical open tray impressions will be poured into a hard dental stone to obtain nine definitive implant casts with conventional implant analogs to act as a reference comparator. Impressions will be digitized to reference STL files.

conventional physical impressions
digital scanning with coupled scanning aiding deviceDEVICE

Nine optical impressions will be obtained while additional geometric scanning aids are coupled with the scan bodies to get nine CAD/CAM 3D-printed polymer casts with digital implant analogs.

optical impressions with additional geometric scanning aids coupled with the scan bodies
Digital Implant Model assessment of accuracyDEVICE

The nine STL files of optical scanning will serve as reference data for comparison with the digitized DIMs to evaluate the accuracy of representation of the actual position of implants in the software.

optical impressions with additional geometric scanning aids coupled with the scan bodies

Eligibility Criteria

Age45 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients having a completely edentulous lower arch that could be restored by fixed screw-retained implant hybrid dentures.
  • Patients having a substantial bone height and width at prospective implant sites to install four standard-size inter-foraminal implants.
  • Sufficient crown height space according to criteria of all-on-4.
  • good oral hygiene and motivation

You may not qualify if:

  • Patients with bad oral hygiene.
  • Patients with limited mouth opening.
  • Vulnerable groups.
  • Uncooperative patients.
  • Patients receiving or undergoing radiotherapy or chemotherapy.
  • Patients with systemic diseases affecting bone metabolism.
  • Smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical general dentist at MOH, Master degree candidate in oral and maxillofacial prosthodontics

Study Record Dates

First Submitted

February 20, 2024

First Posted

February 28, 2024

Study Start

April 1, 2024

Primary Completion

October 1, 2024

Study Completion

December 1, 2024

Last Updated

March 6, 2024

Record last verified: 2024-03