NCT07014527

Brief Summary

custom made subperiosteal implants will be designed using the patients' CT data and will be inserted with the help of a surgical guide and loaded by a screw retained full arch prosthesis. accuracy will be assessed

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2025

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 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 11, 2025

Completed
Last Updated

June 11, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

May 25, 2025

Last Update Submit

June 7, 2025

Conditions

Edentulous Alveolar Ridge AtrophyATROPHYC EDENTULOUS JAWEdentulous MaxillaEdentulous Alveolar Ridge In Mandible

Outcome Measures

Primary Outcomes (1)

  • Accuracy

    accuracy of the position of patient specific subperiosteal implants by superimposition of immediately postoperative CT over the preoperative plan and taking linear measurements (in millimeters)

    immediately postoperative

Study Arms (1)

Computer guided custom made subperiosteal implant treatment

EXPERIMENTAL

Patients will receive a patient specific custom made subperiosteal implant and the accuracy will be assessed

Procedure: Patient specific subperiosteal implants

Interventions

Patient specific subperiosteal implantsPROCEDURE

Patient specific subperiosteal implants

Computer guided custom made subperiosteal implant treatment

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adults patients with severely atrophic alveolar ridges in both maxilla and mandible.

You may not qualify if:

  • Alveolar bone dimensions that can allow for root form implant placement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry, Cairo University

Cairo, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

May 25, 2025

First Posted

June 11, 2025

Study Start

January 1, 2025

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

June 11, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

Data will be available upon reasonable request from the authors

Locations

EG(1)