Digital Versus Conventional Full-arch Implant Impression in Maxillary Screw- Retained Implant Prosthesis
Condition: Jaw, Edentulous
MeSH terms: Jaw, Edentulous; Mouth, Edentulous
Study type: Interventional

Summary: 
      28 participants with edentulous maxillary arches were randomly selected and enrolled in two
      equal groups; Group I conventional impression group (CIG) and Group II Digital impression
      group (DIG). All patients were rehabilitated with maxillary screw-retained implant prosthesis
      retained by 6 implants. Prosthodontic complications and peri-implant MBL were registered at
      6,12, and 24 months (m). Data was collected and statistically analyzed.
    

Detailed description: 
      Treatment sequence Pretreatment examination For all participants, diagnosis and treatment
      planning were performed. They were assessed clinically through oral examination by inspection
      and palpation, and radiographically using preoperative panoramic radiograph and cone beam
      computed tomography CBCT to evaluate bone morphology, bone height, bone density, and vertical
      as well as horizontal bone resorption.

      New maxillary complete dentures were fabricated for all participants to serve as
      temporization and to perform prosthetically driven computer guided implant placement.
      Preoperative CBCT scan (i-CAT Visions; Imaging Sciences International, Hatfield, PA, USA) was
      performed for all participants using the newly fabricated dentures with extra oral ready-made
      radiopaque markers. The markers were placed in relation to the maxillary dentures
      laterals/canines position, first premolars position, and first molars position. The
      superimposition of these markers on the maxilla determines the potential implants sites.
      Implant planning was performed and a stereolithographic surgical guide was fabricated with 6
      sleeves on these preplanned implants sites.

      Surgical procedures Computer-guided surgery was performed; each participant of both groups
      received six axially placed implants (Neobiotech, South korea) in the preplanned implant
      positions in maxilla. The final insertion torque for implants was 40 N cm. Post-operative
      instructions were given for patients. Chlorhexidine mouth wash 0.2% was prescribed for two
      weeks.

      Prosthetic procedures Patients of both groups were recalled after a healing period of soft
      and hard tissues of four months for second stage surgery. Transmucosal titanium abutments
      were screwed in after uncovering of the six implants. For the fabrication of the definitive
      prosthesis, two different approaches were implemented: conventional pick up versus digital
      impressions.

      For group I patients (CIG), a conventional open tray full- arch implant impression was
      implemented to fabricate the definitive maxillary screw retained prosthesis. Six long
      impression transfers were screwed over the fixtures. Using a periapical radiographs the
      seating of the open-tray long impression copings was confirmed. Splinting of impression
      copings was performed using special resin (Duralay; Reliance Dental, Alsip, IL, USA)
      (Fig----). Conventional border molding of the custom open trays (Fig----) was performed, then
      light body vinyl polysiloxane (Imprint 3, 3M ESPE, St. Paul, MN, USA) was injected around the
      impression transfer (Fig---). The tray was then filled with a heavy body vinyl polysiloxane
      ((Imprint 3, 3M ESPE, St. Paul, MN, USA) and a conventional pick up impression was made.
      Implant analogues were then attached to the impression copings and stone models were pored to
      replicate the exact implant positions in the cast.

      For group II patients (DIG), a digital full arch implant impression was utilized to fabricate
      the definitive maxillary screw retained prosthesis. A digital IOS (i-500®, Medit, Seoul,
      South Korea) and scan bodies (Neobiotech, South korea) replacing the traditional impression
      copings were used to capture accurately the implant fixtures. Splinting of the scan bodies
      was performed using the same technique employed for the impression transfers. The same
      experienced investigator performed the scanning of the splinted scan bodies applying the
      scanning stitching strategy 20.

      Keeping the IOS light source parallel to the occlusal plane, scanning of the implants started
      from the distal left implant and then the IOS was moved toward the anterior right implant ,
      and then moved back to the distal implant of the left quadrant, while tilting it palatally;
      followed by crossing the occlusal plan toward the buccal side.

      The same scanning pathway was repeated from the starting scan point for each half. Inspection
      of the image and filling of the missing regions were performed by fast passages of the camera
      over the related areas.

      Identical scanning of the other half was performed using consistent scanning procedures, from
      anterior left implant to the right distal implant of the contralateral quadrant. The software
      merges the two halves by applying a stitching algorithm which uses the shared area between
      the two anterior implants. Scanning of the soft tissues was then performed, and matching of
      the soft tissues and scan bodies of related components scans was achieved.

      The "A.I. Scan Body Matching" feature was used in which the library data is aligned
      automatically with the scan data, minimizing the need to scan difficult-to-reach areas.
      Arranging and replacing that scan body data with the library data was completed to reproduce
      the position and angle of the implanted fixtures accurately.

      Scanning of the opposing mandibular arch was accomplished using the same scanning procedures,
      followed by scanning of the buccal surface of the patients teeth in maximum intercuspation
      with the maxillary temporary denture.

      The 3D scans created were then exported in STL format, uploaded and post processing
      accomplished. Accuracy of detail and correct occlusal relationship were evaluated for the
      virtual images and virtual models were created with dental implants in position.

      Virtual digital creation of framework and prosthesis were performed using the CAD software
      (Exocad software, Darmstad, Germany) For both groups, milling of the definitive frameworks
      from titanium was performed in accordance with sending the rapid prototype model to the
      laboratory for the fabrication of the definitive prosthesis. The frameworks were seated and
      screwed to the implants fixtures and passive fit was ensured using Sheffield test. In none of
      the two groups the frameworks needed splitting and reassembling.

      The prosthesis, set up for the esthetic trial placement, constituted by a framework and a
      suprastructure of esthetic material, has been refined in esthetics, function and in relation
      to soft tissues. After the esthetic and functional evaluation, the restoration is finalized,
      over the mesostructure the esthetic material has been added for the rebuilding of teeth with
      composite (NACERA HYBRID, DOCERAM Medical Ceramics GmbH, Dortmund, Germany) and soft tissues.

      For both groups, the definitive prosthesis was cemented to the titanium mesostructured with a
      dual cure cement (Rely X Unicem, 3M, St. Paul, MN, USA), then positioning and screwing of the
      prosthesis onto the dental implants was accomplished and passive fit was ensured using the
      Sheffield test.
    

Intervention name(s): Maxillary screw-retained prosthesis
Intervention type(s): Device
Intervention description(s): Maxillary screw-retained prosthesis with conventional full-arch impression with conventional or digital impression
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: edentulous; implant; Screw retained; Digital impression