Completed

NCT Number: NCT06542562

Accuracy of Fully Guided Versus Half Guided Implant

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

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Key information

Conditions

Complete Edentulism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MSA University

Giza, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

guided implant placement

Procedure

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.

Primary outcomes

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

Time frame: at the day of implant placement

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.

Sponsors and collaborators

Lead sponsor

October University for Modern Sciences and Arts

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Aug 7, 2024
Registry last updated: Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed