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

NCT ID: NCT06519383

Last Updated: 2024-07-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2025-08-31

Brief Summary

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).

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).

Conditions

Implant Placement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

guided implant surgery

Intervention Type: PROCEDURE

Surgical guide is fabricated and fitted onto the patient's arch and implant is placed with guide in place.

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.

Group Type: EXPERIMENTAL

guided implant surgery

Intervention Type: PROCEDURE

Surgical guide is fabricated and fitted onto the patient's arch and implant is placed with guide in place.

Interventions

guided implant surgery

Surgical guide is fabricated and fitted onto the patient's arch and implant is placed with guide in place.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Krishnadevaraya College of Dental Sciences & Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Dr. Prabhuji MLV, MDS

Role: CONTACT

prabhujimlv@gmail.com

9448057407 ext. 91

Dr. Supriya K Hombal, MDS

Role: CONTACT

supriyahombal@gmail.com

9113088652 ext. 91

Other Identifiers

02_D012_00047

Identifier Type: -

Identifier Source: org_study_id