Volumetric Changes of Labial Soft Tissue Contour Following Different Approaches With Immediate Implant Placement
Condition: Dental Implant Placement
Study type: Interventional

Summary: 
      Statement of the problem: Tooth extraction is followed by ridge alteration and soft tissue
      contour collapse. Different strategies were proposed to limit this collapse however, the
      ability of these techniques to mimic the original soft tissue contour and to maintain long
      term stability is unclear. Purpose : The aim of this study is to evaluate the volumetric
      difference of buccal soft tissue contour as well as the radiographic changes, following tooth
      extraction and immediate implant placement with dual zone concept versus connective tissue
      graft. Materials and Methods: Thirty patients with single maxillary anterior or premolar
      tooth indicated for extraction will participate in this study, 15 patient in each group.
      Group 1 (test group) will be treated by immediate implant placement (IIP) with particulate
      bone grafts in the dual zone (the bone zone and the tissue zone) and customized healing
      abutment. Group 2 (control group) IIP with connective tissue graft (CTG) and customized
      healing abutment. Patient allocation is random for the 2 groups. Data will be collected
      pre-surgically and at follow up periods (3,6,9&12 months and 6 months after delivery).
      Extra-oral scanning of the labial contour will be carried out to evaluate difference in
      contour gained and will be compared to the original contour and between treatment groups.
      Radiographic evaluation will be done using CBCT pre-operatively and at 12 months.
    

Detailed description: 
      After administration of local anaesthesia, the tooth will be extracted by the principle
      investigator without raising flaps, as atraumatically as possible by using periotomes without
      disturbing the papillary tissues (minimal traumatic extraction technique). After the
      extraction of the tooth, the socket will be carefully cleaned to excavate the granulation
      tissue in the marginal and apical regions. The allocation will be revealed to the principle
      investigator for the 3 implant groups after implant placement.

      Group 1: extraction will occur and then followed by immediate implant placement,using
      standard implant system protocol preparation of the osteotomy will take place. Initial drill
      will be placed palatally till final drill reached. Placement of the implant without any
      raising of the flap will be performed in the correct implant position. Primary stability of
      the implant will be measured by rotational insertion torque value, to be ≥30Ncm (37).
      Particulate bone grafts are packed in the gap between the implant and the buccal plate of
      bone and the tissue (dual zone), Followed by customized healing abutment, the temporary
      cylindrical abutment twill be screwed to the implant and then flowable composite will be
      injected at the gingival margin level to adapt to the abutment that will be sand-blasted
      previously for mechanical retention of the composite, taking the shape of the socket at the
      marginal gingiva, but will only seal the socket without extending deeper apically in the soft
      tissue. A buccal groove will be made after the polymerization of this material for easier
      application. The abutments will be removed for final configurations of the apical part
      mimicking the emergence profile of the extracted tooth and finishing with laboratory discs
      and burs. The custom healing screw will then be screwed to the implant with the correct
      torque.

      Group 2: Tooth extraction and immediate implant placement as mentioned. Connective tissue
      grafts will be harvested from the hard palate and placed at the implant sites in a
      supraperiosteal partial dissection (pouch technique) prepared at the buccal aspect without
      using vertical incisions and without flap elevation. Sutures will be used to stabilize the
      graft in its desired place, then will be covered by a customized healing abutment that will
      be done as mentioned before.
    

Intervention name(s): Connective tissue graft and customized healing abutment; Dual zone concept and customized healing abutment
Intervention type(s): Procedure; Procedure
Intervention description(s): Immediate implant placement without flap raising using standard implant system protocol preparation will take place. Connective tissue grafts from the hard palate will be placed at the implant sites in a supraperiosteal partial dissection prepared at the buccal aspect. Sutures will be used to stabilize the graft, followed by customized healing abutment. Flowable composite will be injected at the gingival margin level to adapt to the sandblasted abutment, taking the shape of the socket at the marginal gingiva. Buccal groove will be made after the polymerization of this material for easier application. The abutments will be removed for final configurations of the apical part mimicking the emergence profile of the extracted tooth and finishing with laboratory discs and burs. The custom healing screw will be screwed to the implant.; Immediate implant placement without flap raising using standard implant system protocol preparation will take place. Followed by bone grafting following dual zone concept and customized healing abutment.
Other intervention name(s): zimmer biomed dental implants and connective tissue grafts and customized healing abutments; zimmer biomed dental implants and dual zone bone grafting and customized healing abutments
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: • To compare the volumetric changes in the buccal soft tissue contour between immediate implants with CTG and customized healing abutments, and immediate implants with bone grafting in the dual zone and customized healing abutmnets
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Immediate implant placement; Connective tissue graft; dual-zone therapeutic concept; customized healing abutment; buccal soft tissue contour; volumetric analysis