Comparison Of Implant Position Achieved With Fully Guided Versus Partially Guided Implant Placement

July 19, 2024 updated by: Krishnadevaraya College of Dental Sciences & Hospital

Comparative Evaluation Of Accuracy Of Implant Position Achieved With Static Computer Assisted Fully Guided Implant Placement (sCAIP) And Conventional Cast Based Partially Guided Implant Placement (cPGIP)

Globally implant therapy is currently accepted as a predictable, viable and successful option to replace missing teeth. Ample studies have shown excellent survival and clinical success rates of dental implants for various indications.The correct three-dimensional (3D) positioning of an implant is considered a prerequisite for an optimal outcome.Computer assisted implant surgery maybe beneficial in patients with limited bone and proximity to anatomic structures.Therefore, the aim of this randomized controlled clinical trial is to investigate the accuracy of implant position achieved with static CAIP(Computer Assisted Implant Placement) and to compare this with the accuracy of conventional cast based partially guided implant placement(cPGIP).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Globally implant therapy is currently accepted as a predictable, viable and successful option to replace missing teeth.As a result, the focus in contemporary implant dentistry has shifted towards the optimization of treatment concepts with aesthetics and function as an important outcome parameter.In this respect, implant installation should be prosthetically -driven, at the same time taking into account anatomical limitations as well as restrictions in terms of bone availability. Apart from aesthetics, a correct implant position may reduce biological and technical complications, favourable esthetic and prosthetic outcome, long term stability of peri-implant tissues, optimal occlusal contacts and implant loading. One possible tool that may facilitate a more accurate implant positioning is guided implant surgery.Virtual implant planning facilitates desired inter implant distance and depth. A top down planning wherein digital images of the edentulous area and mock wax up of the prosthesis is superimposed, allows precise implant placement planning. This digital planning can be converted into a surgical/virtual guide via a 3D printer or a milling machine.Fully guided surgery is based on a surgical guide which will assist the clinician in every step of the surgery starting from the first drill to the implant placement through the use of guiding sleeves in the guide. A partially-guided protocol differs only in the final step: after guided preparation of the osteotomy, the guide is removed and the implant is installed free-handedly.Therefore, the aim of this randomized controlled clinical trial is to investigate the accuracy of implant position achieved with static CAIP(Computer Assisted Implant Placement) and to compare this with the accuracy of conventional cast based partially guided implant placement(cPGIP).

Study Type

Interventional

Enrollment (Estimated)

20

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 Contact

Study Contact Backup

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:

  • Patients in need of replacement of missing teeth.
  • Mouth opening at least 30 mm.
  • Age>18 years.
  • Limited vertical or horizontal dimension of the alveolar ridge.
  • Unfavorable bone morphology necessitating correct implant position.
  • When minimally invasive (e.g. flapless) surgery is intended.
  • When immediate implant restoration is planned.

Exclusion Criteria:

  • Heavy smokers (more than 10 cigarettes per day)
  • Uncontrolled diabetes
  • Metabolic bone disorders
  • History of radiotherapy of the head and neck
  • Recent chemotherapy
  • Use of drugs influencing bone or soft tissue healing (e.g., high doses of antiresorptive medication, steroids or anti-inflammatory drugs)
  • Pregnant and/or lactating women

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Implant placement by static computer assisted implant placement(fully guided).
The Digital Imaging and Communications in Medicine (DICOM) file from the CBCT examination and the Standard Tessellation Language (STL) file from the surface scan will be imported and merged in planning software .The virtual implant planning for all patients will be performed in 3shape software.Surgical guide with embedded sleeve will be designed and 3D printed using computer-aided design/computer-aided manufacturing (CAD/CAM) technology.Fit and stability of static CAD\CAM surgical guide for test group will be verified through window areas of guide on top of the teeth.A flapless implant placement protocol will be performed for all implants.
Procedure: guided implant surgery
Surgical guide is fabricated and fitted onto the patient's arch and implant is placed with guide in place.
Experimental: Implant placement by conventional cast based partially guided implant placement(partially guided).
A conventional acrylic stent with radiopaque marker (barium sulphate) will be fabricated which will serve as radiographic template.A CBCT (cone beam computed tomography) examination will be performed with the patient wearing radiographic template.The DICOM file will be then imported in planning software. Virtual implant planning will be performed in 3 shape software.A surgical stent will be produced in a conventional laboratory manner. A flapless implant placement protocol will be performed.
Procedure: guided implant surgery
Surgical guide is fabricated and fitted onto the patient's arch and implant is placed with guide in place.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of implant position
Time Frame: 2 weeks
3D deviation of planned implant position to final implant position
2 weeks

Collaborators and Investigators

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

Sponsor

Krishnadevaraya College of Dental Sciences & Hospital

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)

July 1, 2024

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

July 19, 2024

First Submitted That Met QC Criteria

July 19, 2024

First Posted (Actual)

July 25, 2024

Study Record Updates

Last Update Posted (Actual)

July 25, 2024

Last Update Submitted That Met QC Criteria

July 19, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 02_D012_00047

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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