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Using Superimposition of Intra-Oral Scan and CBCT in Single Implant Restorations in Aesthetic Zone.

F

Faculty of Dental Medicine for Girls

Status

Invitation-only

Conditions

Patient Satisfaction
Dental Implant

Treatments

Other: superimposition of DICOM file from CBCT and STL file of Intraoral scanner

Study type

Interventional

Funder types

Other

Identifiers

NCT05053958
P-CR-21-06

Details and patient eligibility

About

This study will be performed to evaluate patients'satisfaction and aesthetic outcomes of single implant restorations in aesthetic zone by using superimposition of intra-oral scan and CBCT.

Full description

The accurate transfer of an ideal implant position from virtual planning to the actual implant site is essential for protecting vital structures as well as optimizing esthetic and functional outcomes.With the introduction of 3D imaging and implant planning software, preoperative design for a "prosthesis-driven" implant position becomes a reality.

The initial stage is digital image acquisition, which can be from extra-oral means such as cone beam computed tomography (CBCT) and laboratory scanners, or intraoral means such as intraoral scanners.

Image fusion or superimposition of the STL data obtained from the optical scanning, with the DICOM data obtained from the CBCT, is performed by matching the common reference points prior to implant planning.

The superimposed images enable virtual implant planning, while taking the surrounding anatomic structures and future prosthetic needs into consideration.

To conduct the present study, the following will be used:

  1. DICOM file of CBCT for examination of single implant in aesthetic zone.
  2. STL file of optical scanning for examination of single implant in aesthetic zone.
  3. An implant planning software.
  4. One type of dental implant.

Enrollment

14 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. At least 1 tooth having missed within 3-4 months or to be extracted in anterior zone, and the remaining teeth are adequate to support the surgical template.
  2. Sufficient bone tissue to insert an implant without any need for augmentation (the residual bone height ≥ 10 mm, the buccolingual width ≥ 7 mm, and the labial bone plate is complete without bone dehiscence and fenestration).
  3. Good treatment compliance.

Exclusion criteria

  1. Presence of uncontrolled systemic diseases, infection, or inflammation around the implant sites.
  2. Pregnancy or lactation.
  3. Poor oral hygiene habits.
  4. Psychiatric problems, alcohol, tobacco (>10 cigarettes per day) or drug abuse.
  5. Severe bruxism or clenching.
  6. Not able to complete the follow-up.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

14 participants in 2 patient groups

Implant planning without using superimposition of intraoral scan and CBCT.
No Intervention group
Description:
Patients will receive a pre-operative CBCT examination. Implants will be inserted using freehand drilling protocol. The implants will be placed using flapless technique with the reference of neighboring teeth and 3D radiographic information.
Implant planning using superimposition of intraoral scan and CBCT.
Active Comparator group
Description:
Patients will receive a pre-operative CBCT examination and optical scan of the oral tissues by intra-oral scanner. Digital Imaging and Communications in Medicine (DICOM) file from the CBCT examination and the Standard Tessellation Language (STL) file from the optical scan will be imported and merged in implant planning software. The virtual implant planning will be performed. The surgical guide and prosthesis are designed according to the virtual plan.
Treatment:
Other: superimposition of DICOM file from CBCT and STL file of Intraoral scanner

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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