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Accuracy of Fully Guided Versus Half Guided Implant

Not Applicable
Completed
Conditions
Complete Edentulism
Registration Number
NCT06542562
Lead Sponsor
October University for Modern Sciences and Arts
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

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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
16
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Rate of Angle Deviation in Implant Placement: Fully Guided vs. Half-Guided Approachesat 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

MSA University

🇪🇬

Giza, Egypt

MSA University
🇪🇬Giza, Egypt

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