NCT06990360

Brief Summary

Five stryofoam mandibles were included in this study to assess the accuracy of using computer guided surgical stent in placement of dental implants. The mandibles were CBCT scanned and imported to 3diagnosys software to implant planning. 8 implants were placed in each mandible virtually, 4 anterior implants and 4 posterior implants were placed. The plan was exported as STL file to be imported to the CAD software for designing of the stent. The surgical stent is printed using Micro DGP printer and invision tec e-shell 600 clear resin was used. Stainless steel sleeves were placed in the surgical guide then placed in ethanol 99% to remove the excess monomer. The stent in placed over the mandible and sequential drilling was done until the desired osteotomies width was approached followed by the placement of the implants. Post-operative CBCT was done for the mandible including the implants to assess the accuracy, angulation and position of the placed implants

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2017

Longer than P75 for all trials

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

May 20, 2017

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 25, 2025

Completed
Last Updated

May 30, 2025

Status Verified

May 1, 2025

Enrollment Period

7.3 years

First QC Date

May 18, 2025

Last Update Submit

May 24, 2025

Conditions

Keywords

Computer-guided implant placementEdentulous mandible3D printed surgical guide

Outcome Measures

Primary Outcomes (1)

  • Mesiodistal (MD) Angle

    measures in the software in degrees

    1 year

Interventions

CBCT ScanningDIAGNOSTIC_TEST

The Styrofoam mandibles were scanned using CBCT, which was performed for each mandible pre-operatively, the raw DICOM data set obtained from the CBCT scanning were imported to a special third-party software\* for secondary reconstruction.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Five styrofoam mandibles

You may qualify if:

  • Five styrofoam mandibles

You may not qualify if:

  • no fractures or pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

future university in Egypt

Cairo, Giza Governorate, 123456, Egypt

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Post graduate student

Study Record Dates

First Submitted

May 18, 2025

First Posted

May 25, 2025

Study Start

May 20, 2017

Primary Completion

August 20, 2024

Study Completion

September 20, 2024

Last Updated

May 30, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations