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Clinical Trials/NCT06204692
NCT06204692
Completed
Not Applicable

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

October 6 University1 site in 1 country12 target enrollmentJune 1, 2022
ConditionsDental Implant

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dental Implant
Sponsor
October 6 University
Enrollment
12
Locations
1
Primary Endpoint
marginal bone loss
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2022
End Date
September 28, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nermine Ramadan Mahmoud

Associated Professor, faculty of Dentistry, October 6 University

October 6 University

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.

Outcomes

Primary Outcomes

marginal bone loss

Time Frame: 6 months postoperative

Cone Beam Computed Tomography

Secondary Outcomes

  • post-surgical pain and swelling(7 days prior to implant placement)

Study Sites (1)

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