Computer Guided Versus Freehand Dental Implant Surgery

Not Applicable

Completed

• Conditions: Dental Implant
• Interventions: Procedure: dental implant

• Registration Number: NCT06204692
• Lead Sponsor: October 6 University

Brief Summary

This study's goal is to evaluate the efficacy of traditional rehabilitation with freehand implant implantation of partly or totally edentulous patients utilizing flapless or mini-flap procedures vs. 3D implant design software and specialized surgical templates.

Detailed Description

Patients with at least 7 mm of height and 4 mm of breadth in their bones, who needed at least two implants to be restored with a single prosthesis, were recruited one after the other. Patients were randomly assigned to two groups in a parallel group trial design. : Group I: consisted of 6 patients where computer guided dental implant placement and Group II: included six people who had dental implants placed manually. A temporary prosthesis was inserted into the implants right away, and four to six months later, a permanent prosthesis took its place.

Implant failures, marginal bone loss, number of therapy sessions, length of treatment, post-surgical pain and swelling, use of painkillers, surgical time, time needed to resolve problems, and patient satisfaction were among the outcome variables evaluated by a blinded, independent assessor. Patients were tracked for a full year.

Study Timeline

• Study Start: 2022-06-01
• Primary Completion: 2023-06-30
• Study Completion: 2023-09-28
• Study First Submitted: 2023-12-26
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-10
• Last Update Submitted: 2024-01-10
• Study First Posted: 2024-01-12
• Last Update Posted: 2024-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• totally edentulous in one or both arches,
• with at least 7 mm of height and 4 mm of breadth in their bones as assessed by preoperative CBCT scans.
• patients between the ages of 35 and 65 who could give informed permission,
• Implants next to each other required to be positioned at least 3 mm apart from each other and 1.5 mm apart from the tooth.

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Exclusion Criteria

• Patients who have received radiation therapy to the head and neck region within the year prior to implantation,
• those who are receiving intravenous amino bisphosphonates,
• those who have untreated periodontitis,
• those with uncontrolled diabetes,
• pregnant women, or nursing mothers are among the general contraindications to implant surgery.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Computer Guided Dental Implant Surgery.	dental implant	Computer Guided Dental Implant Surgery

Primary Outcome Measures

Name	Time	Method
marginal bone loss	6 months postoperative	Cone Beam Computed Tomography

Secondary Outcome Measures

Name	Time	Method
post-surgical pain and swelling	7 days prior to implant placement	Visual Analog Scale (10 represent maximum pain , 0 represent no pain)

Trial Locations

Locations (1)

nermine Ramadan Mahmoud; 🇪🇬 Cairo, Egypt