NCT06542562

Brief Summary

six implants will be placed in edentulous maxilla to rehabilitate patients with implant prosthesis.The primary outcome measure will be the accuracy of implant placement, which will be evaluated using cone-beam computed tomography (CBCT) scans

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2024

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

August 1, 2024

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2025

Completed
Last Updated

August 1, 2025

Status Verified

July 1, 2024

Enrollment Period

8 months

First QC Date

August 5, 2024

Last Update Submit

July 29, 2025

Conditions

Keywords

implants

Outcome Measures

Primary Outcomes (1)

  • Rate of Angle Deviation in Implant Placement: Fully Guided vs. Half-Guided Approaches

    Post-surgery, 16 patients will be scanned using the same CBCT machine and exposure settings. Preoperative and postoperative CBCT scans will be imported into the In2Guide™ software, where an overlay of the preoperative plane onto the postoperative scan allowed for precise evaluation of implant positioning. Implant deviations will be measured in three directions: angular deviation, deviation at the coronal platform (entry deviation), and deviation at the apical portion (Figure 2). The software generated coordinates for the necessary calculations, with coronal and apical deviations reported in millimeters and angular deviation in degrees.

    at the day of implant placement

Study Arms (2)

Group 1 will undergo fully guided dental implant surgery

EXPERIMENTAL

Group 1 will undergo fully guided dental implant surgery

Procedure: guided implant placement

Group 2 will undergo half guided dental implant surgery

EXPERIMENTAL

Group 2 will undergo half guided dental implant surgery. Where the implant will be placed after removal of the guide

Procedure: guided implant placement

Interventions

The key difference is that in Group 1, the guide is only used for the drilling sequence, while in Group 2 the guide is used for both the drilling and the actual implant placement.

Group 1 will undergo fully guided dental implant surgeryGroup 2 will undergo half guided dental implant surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 years or older
  • Complete edentulism
  • Adequate bone volume to accommodate six standard implant fixtures (3.7 mm diameter and 10 mm length)
  • All patients underwent a panoramic X-ray and an oral examination
  • Written consent provided prior to participation

You may not qualify if:

  • Patients with partial edentulism
  • Insufficient bone volume for a 3.7 mm diameter and 10 mm length implant fixture
  • Local or systemic conditions that could impede dental implant surgery
  • Patients who smoke more than five cigarettes per day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MSA University

Giza, Egypt

Location

Related Publications (1)

  • Alqutaibi AY, Al-Gabri RS, Ibrahim WI, Elawady D. Trueness of fully guided versus partially guided implant placement in edentulous maxillary rehabilitation: a split-mouth randomized clinical trial. BMC Oral Health. 2025 Oct 27;25(1):1680. doi: 10.1186/s12903-025-07073-0.

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
SPONSOR

Study Record Dates

First Submitted

August 5, 2024

First Posted

August 7, 2024

Study Start

August 1, 2024

Primary Completion

March 24, 2025

Study Completion

April 24, 2025

Last Updated

August 1, 2025

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations