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Vertical Augmentation Using Onlay Versus Inlay Autogenous Graft With Simultaneous Implant Placement.

Primary Purpose

Bone Resorption

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
assigned intervention
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Resorption

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • * Patients with partially edentulous anterior maxillary ridges.

    • Patients were free from any systemic disease that interferes with bone healing.
    • Absence of local pathosis at anterior maxillary area.
    • No history of any grafting procedure at the designated edentulous ridge.

The edentulous ridge vertical dimension was less than 10 mm measured from the alveolar crest to the nasal floor (i.e.ridge had vertical inadequacy) with normal horizontal alveolar dimension or patient with Increased Inter-Arch Space.

Exclusion Criteria:

  • * Patient with fully dentulous maxilla.

    • Pregnant females.
    • Presence of bad habits (severe bruxism, clenching).
    • Systemic diseases that may interfere with bone healing.e.g. uncontrolled Diabetes.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    control

    Comparator

    Arm Description

    Crestal pyramidal flap will be done with 2 releasing incisions for adequate exposure. Buccal& palatal full reflection for adequate exposure and to avoid the interference between the onlay graft and the residual bone. Decortication of the bone bed to increase the blood supply to the onlay graft. The block graft harvested from the chin is placed crestal to the residual ridge and stabilized in place using dental implant immediately. Periosteal incisions are usually needed to allow tension free sutures. Vicryl 3/0 sutures for closer. augmentin 1g twice daily for 5 days. catflam 50g twice daily for 3 days

    Crestal incision with labial flap reflected leaving the palatal tissues without elevation. Marking of the 3 bony cuts ( 2 vertical cuts & 1 horizontal cut ) using fine fissure bur in the form of perforations along the cuts position. Drilling of pilot drill and first drill only. 3 full thickness cuts will be performed (2 vertical stop cuts will be made by using the tungsten carbide disc at the distal ends of the horizontal bony cut on the facial surface of alveolar ridge. splitting osteotomes are used and mallet to complete the splitting of the bony segment. After bony separation the rectangular bony segment (transport segment) will be mobilized occlusally and pedicled on the palatal mucoperiosteum. The autogenous block graft harvested from the chin area is placed in the space gained under the mobile bony segment. Drilling through the bony segment and the block graft. Immediate implant placement chin graft block dental implants

    Outcomes

    Primary Outcome Measures

    vertical Bone gain
    The nasal floor will be used as a fixed reference by adjusting the cross sectional long axis in the center of the area of interest and bisecting it (showing the buccolingual dimension). All the patients will wear the radiographic dentures with radiopaque material (barium sulphate mixed with acrylic powder) filling the teeth at the area of interest to ensure that the calculations were taken at the same region. On the cross sectional view of CBCT and at each proposed implant site, a line will be drawn starting from the crest of the ridge till the nasal floor. The height will be recorded preoperatively, immediately (1 week) and 6 months postoperatively.the difference between them in millimeters will be recorded.

    Secondary Outcome Measures

    crestal bone loss
    crestal bone loss around the implant will be measured in millimeter after 6 months

    Full Information

    First Posted
    February 7, 2017
    Last Updated
    February 20, 2017
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03052387
    Brief Title
    Vertical Augmentation Using Onlay Versus Inlay Autogenous Graft With Simultaneous Implant Placement.
    Official Title
    Assessment of Vertical Bone Augmentation Using Autogenous Onlay Versus Inlay Grafting Techniques With Simultaneous Implant Placement in the Anterior Maxillary Area on Patient's Esthetic Satisfaction : A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2017 (Anticipated)
    Primary Completion Date
    August 2017 (Anticipated)
    Study Completion Date
    December 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Using autogenous Chin block for vertical augmentation with simultaneous implant placement at anterior maxilla region comparing between the Onlay and Inlay grafting techniques.
    Detailed Description
    to study the vertical augmentation with simultaneous implant placement at anterior maxillary region. P: Patient requires implant at anterior maxillary ridge with vertical deficiency. I:Inlay Sandwich Technique with immediate implant placement. C:Onlay autogenous graft immediate implant placement. O:Outcome name Measuring device Measuring unit Primary outcome: Vertical bone gain CBCT Millimeter -Secondary outcome(a): Crestal bone loss CBCT Millimeter

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bone Resorption

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    12 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    control
    Arm Type
    Placebo Comparator
    Arm Description
    Crestal pyramidal flap will be done with 2 releasing incisions for adequate exposure. Buccal& palatal full reflection for adequate exposure and to avoid the interference between the onlay graft and the residual bone. Decortication of the bone bed to increase the blood supply to the onlay graft. The block graft harvested from the chin is placed crestal to the residual ridge and stabilized in place using dental implant immediately. Periosteal incisions are usually needed to allow tension free sutures. Vicryl 3/0 sutures for closer. augmentin 1g twice daily for 5 days. catflam 50g twice daily for 3 days
    Arm Title
    Comparator
    Arm Type
    Active Comparator
    Arm Description
    Crestal incision with labial flap reflected leaving the palatal tissues without elevation. Marking of the 3 bony cuts ( 2 vertical cuts & 1 horizontal cut ) using fine fissure bur in the form of perforations along the cuts position. Drilling of pilot drill and first drill only. 3 full thickness cuts will be performed (2 vertical stop cuts will be made by using the tungsten carbide disc at the distal ends of the horizontal bony cut on the facial surface of alveolar ridge. splitting osteotomes are used and mallet to complete the splitting of the bony segment. After bony separation the rectangular bony segment (transport segment) will be mobilized occlusally and pedicled on the palatal mucoperiosteum. The autogenous block graft harvested from the chin area is placed in the space gained under the mobile bony segment. Drilling through the bony segment and the block graft. Immediate implant placement chin graft block dental implants
    Intervention Type
    Other
    Intervention Name(s)
    assigned intervention
    Intervention Description
    * Local anesthesia with vasoconstrictor(V.C) used for hemostasis. chin block graft Scrubbing and draping of the patient will be carried out in a standard fashion using betadine surgical scrub. The donor site is usually the chin area, its approached using local anesthesia with VC at symphysis region. Low vestibular incision exposing the symphysis area to the inferior border of the mandible. Using fissure bur to harvest the graft for the defect. Closure using vicryl 3-O sutures.
    Primary Outcome Measure Information:
    Title
    vertical Bone gain
    Description
    The nasal floor will be used as a fixed reference by adjusting the cross sectional long axis in the center of the area of interest and bisecting it (showing the buccolingual dimension). All the patients will wear the radiographic dentures with radiopaque material (barium sulphate mixed with acrylic powder) filling the teeth at the area of interest to ensure that the calculations were taken at the same region. On the cross sectional view of CBCT and at each proposed implant site, a line will be drawn starting from the crest of the ridge till the nasal floor. The height will be recorded preoperatively, immediately (1 week) and 6 months postoperatively.the difference between them in millimeters will be recorded.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    crestal bone loss
    Description
    crestal bone loss around the implant will be measured in millimeter after 6 months
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: * Patients with partially edentulous anterior maxillary ridges. Patients were free from any systemic disease that interferes with bone healing. Absence of local pathosis at anterior maxillary area. No history of any grafting procedure at the designated edentulous ridge. The edentulous ridge vertical dimension was less than 10 mm measured from the alveolar crest to the nasal floor (i.e.ridge had vertical inadequacy) with normal horizontal alveolar dimension or patient with Increased Inter-Arch Space. Exclusion Criteria: * Patient with fully dentulous maxilla. Pregnant females. Presence of bad habits (severe bruxism, clenching). Systemic diseases that may interfere with bone healing.e.g. uncontrolled Diabetes.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    assessment of vertical ridge augmentation using autogenous Onlay versus Inlay Bone Grafting techniques in the anterior maxilla.

    Learn more about this trial

    Vertical Augmentation Using Onlay Versus Inlay Autogenous Graft With Simultaneous Implant Placement.

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