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Evaluation of Marginal Bone Loss Using Computer Guided Ridge Splitting Technique With Simultaneous Implant Placement.

Primary Purpose

Marginal Bone Loss, Computer Guided, Ridge Splitting

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Computer guided alveolar ridge splitting technique
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Marginal Bone Loss

Eligibility Criteria

18 Years - 58 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with thin maxillary ridge of 3 to 5 mm thickness of crestal alveolar bone (horizontal deficiency).
  • Patients with free medical history and adequate proper oral hygiene.
  • Patients of adequate alveolar bone height.
  • Both genders males and females will be included.

Exclusion Criteria:

  • General contraindications to implant surgery.
  • Subjected to irradiation in the head and neck area less than 1 year before implantation.
  • Untreated periodontitis.
  • Poor oral hygiene and motivation.
  • Uncontrolled diabetes.
  • Pregnant or nursing.
  • Substance abuse.
  • Psychiatric problems or unrealistic expectations.
  • Severe bruxism or clenching.
  • Immunosuppressed or immunocompromised.
  • Treated or under treatment with intravenous amino-bisphosphonates.
  • Lack of opposite occluding dentition/prosthesis in the area intended for implant placement.
  • Active infection or severe inflammation in the area intended for implant placement.
  • Need of bone augmentation procedures at implant placement.
  • Unable to open mouth sufficiently to accommodate the surgical tooling.
  • any 'complex case' if implants had to be placed in the aesthetic zone defined as second to second maxillary premolars.
  • Patients participating in other studies, if the present protocol could not be properly followed.
  • Requiring only single implant-supported crowns.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Computer guided alveolar ridge splitting technique

    Arm Description

    Computer guided alveolar ridge splitting using piezo electric device and a 3D printed surgical guide. An L shaped splitting pattern with one crestal and one distal cut will be performed.

    Outcomes

    Primary Outcome Measures

    the amount of marginal bone loss
    the amount of marginal bone loss of thin narrow ridge after 6 months of splitting bone taking the implant as guide measured in mm determined on cone beam CT (panoramic and cross-sectional views).

    Secondary Outcome Measures

    Full Information

    First Posted
    June 9, 2019
    Last Updated
    October 18, 2019
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03989193
    Brief Title
    Evaluation of Marginal Bone Loss Using Computer Guided Ridge Splitting Technique With Simultaneous Implant Placement.
    Official Title
    Evaluation of Marginal Bone Loss Using Computer Guided Ridge Splitting With Simultaneous Implant Placement Versus Conventional Technique (a Randomized Clinical Trial)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 1, 2019 (Anticipated)
    Primary Completion Date
    April 1, 2020 (Anticipated)
    Study Completion Date
    July 31, 2020 (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
    Yes

    5. Study Description

    Brief Summary
    This clinical report describes a technique for ridge splitting, and gradual expansion in the maxilla with simultaneous implant placement with in the split ridge, with the preservation of the thin buccal plate of bone for proper blood supply.
    Detailed Description
    All the procedures will perform under local anesthesia (mepivacain with levonordefrin). Horizontal Atrophic maxillary sectors will use for the development of the treatment sequence. All the patients will prepare initially with study models that permitted surgical and prosthetic planning as well as the non-strict surgical guide for intraoperative use. After application of conventional local anesthesia techniques, a full thickness incision 3 line pyramidal flap will be expose the defect ridge. The incision will extend to the next tooth or at least 5 mm more posterior from the end of the osteotomy indicated, securing direct observation of the alveolar crest. With a direct view of the alveolar crest, if the ridge presented a width close to 1.5 mm, the ARST was performed immediately; if it presented less than 1.5 mm, then it was worn down with a diamond bur (low speed motor at 1800 rpm) to reduce the height, obtaining an improved alveolar crest width up to approximately 1.5 mm. With this condition the bone splitting technique could be performed using the piezoelectric system (Piezotome2¨, Satelec Action, France), calibrating the device on the D1 setting and using profuse saline irrigation. The preparation sequence was begun with the CS3 insert until a total depth of 10 mm was achieved across the entire extension of the ridge. The procedure continued with the CS1 insert and finally the CS2 insert. The CS% insert was used in two patients with the possibility of widening the osteotomy segment; this sequence always achieved a complete extension in depth of application. In the study group the vertical bone cuts through the cortical layer. At the distal end of the horizontal split: a vertical cut was made with the high-speed bur within the vicinity of the buccal plate of bone; for the start of the separation. With a full vertical depth of 13 mm. Final design of the splitting cut was (L-SHAPE) SPLIT The control group the vertical bone cuts through the cortical layer. At the distal and mesial end of the horizontal split: a vertical cut was made with the high-speed bur within the vicinity of the buccal plate of bone; for the start of the separation. With a full vertical depth of 13 mm corresponding and joining the previous vertical cut. Using the expander to do the implants bed.-Preparation of the implant bed in the mesial end of the horizontal split using the spreading kit.-The final size spreader in the first implant osteotomy site with the first spreader in the second implant bed 3 mm apart. Dental implant placement. Placing the first implant in place while the separation kept preserved .placing the last spreader in the second implant osteotomy site. Bone deficiency is addressed by filling with osteoplastic material; a bio resorbing barrier membrane is arranged. CBCT assessment For the calculation of marginal bone loss(MBL), the implant will use as a reference by adjusting the cross-sectional long axis in the center of the implant and bisecting it (showing the buccolingual and mesiodistal dimensions). On the cross-sectional view, a line will draw just parallel to the implant, starting at the crest of the labial plate of bone and ending at the apical level of the implant; height will recorded in millimeters. The same process was repeated from the palatal direction. The panoramic view (longitudinal cut) will utilized to calculate the mesial and distal bone heights in millimeters.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Marginal Bone Loss, Computer Guided, Ridge Splitting

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    12 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Computer guided alveolar ridge splitting technique
    Arm Type
    Experimental
    Arm Description
    Computer guided alveolar ridge splitting using piezo electric device and a 3D printed surgical guide. An L shaped splitting pattern with one crestal and one distal cut will be performed.
    Intervention Type
    Device
    Intervention Name(s)
    Computer guided alveolar ridge splitting technique
    Intervention Description
    The bone splitting technique could be performed using the piezoelectric system, calibrating the device on D1 setting and using profuse saline irrigation. The preparation sequence begins with CS3 insert until a total depth of 10mm was achieved across the entire extension of the ridge. The procedure continued with the CS1 insert and finally the CS2 insert. The vertical bone cuts through the cortical layer: At the distal end of the horizontal split, a vertical cut will made with the high-speed bur within the vicinity of the buccal plate to start the separation, with a full vertical depth of 13 mm. Final design of the splitting cut was L-shaped split. At the distal and the mesial end of the horizontal split, a vertical cut was made with the high-speed bur for a full vertical depth of 13mm.
    Primary Outcome Measure Information:
    Title
    the amount of marginal bone loss
    Description
    the amount of marginal bone loss of thin narrow ridge after 6 months of splitting bone taking the implant as guide measured in mm determined on cone beam CT (panoramic and cross-sectional views).
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    58 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with thin maxillary ridge of 3 to 5 mm thickness of crestal alveolar bone (horizontal deficiency). Patients with free medical history and adequate proper oral hygiene. Patients of adequate alveolar bone height. Both genders males and females will be included. Exclusion Criteria: General contraindications to implant surgery. Subjected to irradiation in the head and neck area less than 1 year before implantation. Untreated periodontitis. Poor oral hygiene and motivation. Uncontrolled diabetes. Pregnant or nursing. Substance abuse. Psychiatric problems or unrealistic expectations. Severe bruxism or clenching. Immunosuppressed or immunocompromised. Treated or under treatment with intravenous amino-bisphosphonates. Lack of opposite occluding dentition/prosthesis in the area intended for implant placement. Active infection or severe inflammation in the area intended for implant placement. Need of bone augmentation procedures at implant placement. Unable to open mouth sufficiently to accommodate the surgical tooling. any 'complex case' if implants had to be placed in the aesthetic zone defined as second to second maxillary premolars. Patients participating in other studies, if the present protocol could not be properly followed. Requiring only single implant-supported crowns.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Basel Omer, MSc
    Phone
    +201091181748
    Email
    baselhamzah@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ragia Mounir, PhD
    Phone
    +2010066993

    12. IPD Sharing Statement

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