Computer Guided Versus Freehand Dental Implant Surgery

NCT ID: NCT06204692

Last Updated: 2024-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2023-09-28

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.

Conditions

Dental Implant

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Computer Guided Dental Implant Surgery.

Computer Guided Dental Implant Surgery

Group Type: OTHER

dental implant

Intervention Type: PROCEDURE

consisted of 6 patients where computer guided dental implant placement

Interventions

dental implant

consisted of 6 patients where computer guided dental implant placement

Intervention Type: PROCEDURE

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

October 6 University

OTHER

Sponsor Role: lead

Responsible Party

Nermine Ramadan Mahmoud

Associated Professor, faculty of Dentistry, October 6 University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

nermine Ramadan Mahmoud

Cairo, , Egypt

Countries

Egypt

Other Identifiers

October6U

Identifier Type: OTHER

Identifier Source: secondary_id

RECO6U/29-2022

Identifier Type: -

Identifier Source: org_study_id