Computer Guided Versus Freehand Dental Implant Surgery

Dental Implant Clinical Trial

— dental implant  

Official title:

Computer Guided Versus Freehand Dental Implant Surgery: Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06204692
• Other study ID #: RECO6U/29-2022
• Secondary ID: October6U
• Status: Completed
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: September 28, 2023

Study information

• Verified date: January 2024
• Source: October 6 University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 28, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Implant

Intervention

Procedure:
• dental implant
consisted of 6 patients where computer guided dental implant placement

Locations

Country	Name	City	State
Egypt	nermine Ramadan Mahmoud	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
October 6 University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	marginal bone loss	Cone Beam Computed Tomography	6 months postoperative
Secondary	post-surgical pain and swelling	Visual Analog Scale (10 represent maximum pain , 0 represent no pain)	7 days prior to implant placement