NCT06519383

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2024

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 25, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

July 25, 2024

Status Verified

July 1, 2024

Enrollment Period

1.1 years

First QC Date

July 19, 2024

Last Update Submit

July 19, 2024

Conditions

Implant Placement

Outcome Measures

Primary Outcomes (1)

  • Accuracy of implant position

    3D deviation of planned implant position to final implant position

    2 weeks

Study Arms (2)

Implant placement by static computer assisted implant placement(fully guided).

EXPERIMENTAL

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

Implant placement by conventional cast based partially guided implant placement(partially guided).

EXPERIMENTAL

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

Interventions

guided implant surgeryPROCEDURE

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).Implant placement by static computer assisted implant placement(fully guided).

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Dr. Prabhuji MLV, MDS

CONTACT

9448057407prabhujimlv@gmail.com

Dr. Supriya K Hombal, MDS

CONTACT

9113088652supriyahombal@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2024

First Posted

July 25, 2024

Study Start

July 1, 2024

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

July 25, 2024

Record last verified: 2024-07