Dynamic Guided Implant Surgery VS Static Guided Surgery.

May 20, 2024 updated by: Jordi Marquès Guasch, Universitat Internacional de Catalunya

Dynamic Guided Implant Surgery VS Static Guided Surgery. A Pilot Randomized Clinical Trial.

This study aims to evaluate if dynamic-guided surgery is an accurate system for placing dental implants.

Researchers will assess the dental implant accuracy of the dynamic guided system compared to the static pilot guide.

Participants will:

  • Receive implant treatment that will be placed by a dynamic or static pilot drill guided system.
  • Receive post-operative radiological exam for comparative (on the same appointment).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Sant Cugat Del Vallès, Barcelona, Spain, 08195
        • Recruiting
        • Universitat Internacional de Catalunya
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18 years or older,
  • ASA type 1 or 2,
  • Full mouth plaque scores up to 25% (O'LEARY TJ. The plaque control record 1972;43:38), -Partially edentulous with at least one missing tooth
  • Having a bone crest of at least 10mm in length and 6mm in width.

Exclusion Criteria:

  • medical conditions contraindicating surgery,
  • untreated periodontal disease or caries
  • the need for bone augmentation
  • acute local infections
  • history of head/neck radiation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test group or Dynamic guided group
in this arm, the position and angulation of the implant in the patient's mouth will be guided by a dynamic guided system.
Device: Dental implant placement
Dental implant placement guided by Navident® (ClaroNav Inc., Toronto, Canada)
Other Names:
  • dynamic guided implant placement
Active Comparator: Control group or Static guided group
In this arm, the position and angulation of the implant in the patient's mouth will be guided by a stereolitographic pilot drill guide.
Procedure: Static guided implant placement
Dental implant placement guided by a stereolithographic pilot drill guide.
Other Names:
  • control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant placement accuracy at the implant platform level
Time Frame: The data for the assessment is collected during the same appointment as the implant placement and requires an additional 20 minutes.
Implant placement accuracy compared with the implant planning. Expressed in mm.
The data for the assessment is collected during the same appointment as the implant placement and requires an additional 20 minutes.
Implant placement accuracy at the implant apex level
Time Frame: The data for the assessment is collected during the same appointment as the implant placement and requires an additional 20 minutes.
Implant placement accuracy compared with the implant planning. Expressed in mm.
The data for the assessment is collected during the same appointment as the implant placement and requires an additional 20 minutes.
Implant placement accuracy at an angular evel
Time Frame: The data for the assessment is collected during the same appointment as the implant placement and requires an additional 20 minutes.
Implant placement accuracy compared with the implant planning. Expressed in degrees.
The data for the assessment is collected during the same appointment as the implant placement and requires an additional 20 minutes.
Implant placement accuracy at the vertical plane.
Time Frame: The data for the assessment is collected during the same appointment as the implant placement and requires an additional 20 minutes.
Implant placement accuracy compared with the implant planning. Expressed in mm.
The data for the assessment is collected during the same appointment as the implant placement and requires an additional 20 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitat Internacional de Catalunya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 30, 2024

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

May 13, 2024

First Submitted That Met QC Criteria

May 13, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2024

Last Update Submitted That Met QC Criteria

May 20, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIR-ECL-2018-09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Plan to publish the IPD.

IPD Sharing Time Frame

when the data is available during the publication process

IPD Sharing Supporting Information Type

  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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