Accuracy of Fully Guided Versus Half Guided Implant

Accuracy of Fully Guided Versus Half Guided Implant Placement in Patients With Edentulous Maxilla: A Split-mouth Randomized Clinical Trial

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

Study Overview

• Status: Completed
• Conditions: Complete Edentulism
• Intervention / Treatment: Procedure: guided implant placement

Detailed Description

Study Design:

This will be a Split mouth randomized controlled trial (RCT) study. 16 patients missing teeth in the maxillary (upper) jaw and eligible for dental implant treatment will be recruited.

Interventions will be randomly assigned to the right or the left side of the arch :

Group 1 will undergo fully guided dental implant surgery. Group 2 will undergo partially guided dental implant surgery.

Study Duration:

The total duration of the study is estimated to be 5 months. Recruitment and enrollment of patients: 1 months Dental implant surgery : 3 months Data analysis and manuscript preparation: 1 months

The key steps are:

Recruit 16 eligible patients missing teeth in the maxillary jaw. Randomly assign right or left side of the maxillary arch of patients to either the fully guided or partially guided implant surgery group.

Perform CBCT (cone-beam computed tomography) scans before and after the implant surgery for both groups.

Assess the accuracy of implant placement in both groups using the CBCT data. Conduct statistical analysis to determine if there are any statistically significant differences in implant placement accuracy between the two groups.

Interpret the results and develop recommendations on the optimal guided surgery technique for rehabilitating the edentulous maxilla using dental implants.

The study aims to provide scientific evidence to guide clinicians in selecting the most appropriate guided surgery approach for maxillary implant rehabilitation

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • MSA University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 will undergo fully guided dental implant surgery	Procedure: guided implant placement; 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.
Experimental: Group 2 will undergo half guided dental implant surgery; Group 2 will undergo half guided dental implant surgery. Where the implant will be placed after removal of the guide	Procedure: guided implant placement; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: October University for Modern Sciences and Arts

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Actual): March 24, 2025
• Study Completion (Actual): April 24, 2025

Study Registration Dates

• First Submitted: August 5, 2024
• First Submitted That Met QC Criteria: August 5, 2024
• First Posted (Actual): August 7, 2024

Study Record Updates

• Last Update Posted (Actual): August 1, 2025
• Last Update Submitted That Met QC Criteria: July 29, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: implants
• Other Study ID Numbers: UMSA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No