Clinical trial NCT06542562: Accuracy of Fully Guided Versus Half Guided Implant
Official title: Accuracy of Fully Guided Versus Half Guided Implant Placement in Patients With Edentulous Maxilla: A Split-mouth Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Complete Edentulism
Keywords: implants
Lead sponsor: October University for Modern Sciences and Arts
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:all patients underwent a panoramic X-ray and an oral examination. Inclusion criteria consisted of patients aged 18 years or older with complete edentulism and adequate bone volume to accommodate six standard implant fixtures measuring 3.7 mm in diameter and 10 mm in length. -

Exclusion Criteria:Conversely, patients with partial edentulism, insufficient bone volume for a 3.7 mm diameter and 10 mm length implant fixture, or any local/systemic condition that could impede dental implant surgery were excluded from the study. Additionally, patients who smoked more than five cigarettes per day were also excluded. It is important to note that all patients provided written consent prior to their participation in the study. -

Primary outcomes:
measure: evaluation of accuracy
timeFrame: day of implant placement
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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