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OpenTrials
Completed

NCT Number: NCT06204692

Computer Guided Versus Freehand Dental Implant Surgery

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.

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Key information

Conditions

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

nermine Ramadan Mahmoud

Cairo, 12566, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dental implant

Procedure

consisted of 6 patients where computer guided dental implant placement

Primary outcomes

  1. marginal bone loss

    Time frame: 6 months postoperative

    Cone Beam Computed Tomography

Secondary outcomes

  1. post-surgical pain and swelling

    Time frame: 7 days prior to implant placement

    Visual Analog Scale (10 represent maximum pain , 0 represent no pain)

Sponsors and collaborators

Lead sponsor

October 6 University

Other

Registry information

Official study title

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

Acronym: dental implant

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 12, 2024
Registry last updated
Jan 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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