NCT06177782

Brief Summary

The clinical performance of a novel scan body Tooth Modified Scan Body (TMSB) in the degree of trueness of IOS impression for full arch cases. I

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 10, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2023

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 11, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 20, 2023

Completed
Last Updated

December 20, 2023

Status Verified

December 1, 2023

Enrollment Period

9 months

First QC Date

December 11, 2023

Last Update Submit

December 11, 2023

Conditions

Keywords

Jaw relationScan body

Outcome Measures

Primary Outcomes (1)

  • Degree of trueness

    Digital files will be obtained: either conventional scan or TMSB scan. All the STL files will be imported to dental CAD software , and scan bodies will be converted to implant multi-unit ti-base replicas using a digital library. Then, updated STL files will be imported to inspection software for trueness assessments.

    Immediately postoperative

Study Arms (2)

Tooth Modified Scan Bodies

ACTIVE COMPARATOR

The intraoral scanner (IOS) impression will be recorded using modified scan bodies. The IOS device will be calibrated right before the impression. The scan strategy will be consistent for all the procedures following the manufacturer guidelines.

Device: Tooth modified scan bodies

Conventional Scan Bodies

PLACEBO COMPARATOR

The intraoral scanner (IOS) impression will be recorded using conventional implant scan bodies secured at the multiunit abutment level.

Device: Conventional scan bodies

Interventions

Tooth modified scan bodies are used during scanning for full arch implant cases.

Tooth Modified Scan Bodies

Conventional scan bodies will be used for scanning the full arch implant cases.

Conventional Scan Bodies

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Participants who had received 4-6 implants in 1 edentulous arch.
  • Participants with 1-piece implant-supported complete-arch fixed dental prostheses.
  • Systemically free.
  • Primary implant stability exceed 72 the day of the definitive impression.

You may not qualify if:

  • Smoker's.
  • Non co-operative patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Abbassia, 11566, Egypt

Location

Related Publications (1)

  • Eldabe AK, Adel-Khattab D, Botros KH. Trueness of tooth modified scan bodies as a novel technique for edentulous full arch implant supported dental prosthesis: an in vivo prospective comparative study. BMC Oral Health. 2025 Jan 6;25(1):29. doi: 10.1186/s12903-024-05172-y.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 11, 2023

First Posted

December 20, 2023

Study Start

January 10, 2023

Primary Completion

October 18, 2023

Study Completion

November 20, 2023

Last Updated

December 20, 2023

Record last verified: 2023-12

Locations