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Assessment of GBR in Augmentation of Horizontally Atrophic Maxillary Ridge Using Collagen Membrane Versus Using Titanium Mesh

Primary Purpose

Horizontal Ridge Deficiency

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
titanium mesh
collagen membrane (Sausage technique)
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Horizontal Ridge Deficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Patients with horizontal atrophied maxillary ridge (thin ridge) less than 4mm.
  2. All ages and both sexes were included in this study.
  3. Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
  4. Patients with physical and psychological tolerance

Exclusion Criteria:

  1. Patients with high risk systemic diseases like uncontrolled diabetes mellitus. As uncontrolled diabetes mellitus has a negative impact on normal bone healing. 8
  2. Heavy smokers.4
  3. Alcohol or drug abuse
  4. Gingival bleeding or full mouth plaque index ≥ 25%.4
  5. Patients with physical and psychological intolerance. As psychological stress will affect the immune system and patient's fitness including healing capacity. 9
  6. Unavailability for regular follow-ups

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    titanium mesh

    collagen membrane(Sausage technique)

    Arm Description

    using non resorbable titanium mesh to fix and cover the onlay bone graft mixture to the atrophic maxillary ridge.

    using resorbable collagen membrane with the sausage technique to fix the onlay bone graft mixture to the resorbed atrophic maxillary ridge

    Outcomes

    Primary Outcome Measures

    membrane exposure
    clinical postoperative complications as flap dehiscence and membrane exposure into the oral cavity, its a binary outcome (yes/No) examined and recorded by the investigator.
    infection
    suppuration collection related to the membrane and flap, its a binary outcome (yes/No) examined and recorded by the investigator.
    inflammation
    redness and tenderness of the flap, its a binary outcome (yes/No) examined and recorded by the investigator.

    Secondary Outcome Measures

    bone width gain
    the amount of bone gained( in millimeter) after augmentation compared to the initial ridge thickness measured clinically using a caliper 2 mm below the crest of the ridge, and radiographically using the Planmeca Promax 3D CBCT unit which will be viewed on planmeca romexis software to calculate the measures needed in millimeter by the outcome assessor.
    bone quality
    histomorphometric analysis of the bone biopsy taken from the augmented bone to show the quality of the formed bone and the percentage of every type of tissue formed in the specimen taken( unit is area percentage %)

    Full Information

    First Posted
    August 13, 2018
    Last Updated
    August 15, 2018
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03635658
    Brief Title
    Assessment of GBR in Augmentation of Horizontally Atrophic Maxillary Ridge Using Collagen Membrane Versus Using Titanium Mesh
    Official Title
    Assessment of Guided Bone Regeneration in Augmentation of Horizontally Atrophic Maxillary Ridge Using Collagen Membrane Versus Using Titanium Mesh: a Randomized Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2018 (Anticipated)
    Primary Completion Date
    March 1, 2019 (Anticipated)
    Study Completion Date
    October 1, 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

    5. Study Description

    Brief Summary
    this study is aiming to Assess postoperative complications and bone quality and quantity in augmentation of horizontally atrophic maxillary ridge using a 1:1 mixture of autograft and xenograft particulate bone covered with collagen membrane with the new Sausage technique™ versus using the same mixture covered with titanium mesh.
    Detailed Description
    patients with atrophic maxillary ridge < 4 mm will be selected in this study for augmentation for future implant placement. The full thickness flap will be elevated including one extra tooth on each side of the edentulous area or if completely edentulous 5 mm on each side.. the bone bed will be prepared by cleaning any debris and Multiple decortication holes will be performed with a 2.0 mm round bur. the harvested bone from the chin is then mixed with the xenograft with ratio 1:1 and then put on the recipient site and will be covered with a collagen membrane with the Sausage technique (intervention group) and the other group the graft will be covered with titanium mesh (control group). flap is repositioned and sutured. followup for 6 months and then CBCT is done. Reopening after 6 months, core biopsy is taken by a 2 mm thickness trephine from the healed augmented bone at the site of implant placement and will be sent for histomorphometric analysis and the bone thickness (buccolingual ) dimension is measured using a caliper and from the CBCT (cone beam CT) the bone width gain will be calculates and recorded. postoperative complications( infection, wound dehiscence or membrane exposure) will be monitored and recorded.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Horizontal Ridge Deficiency

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    the participants are divided into two groups one control and the other is the intervention
    Masking
    None (Open Label)
    Masking Description
    because the two interventions used in this trial are clearly different and easily recognized by the investigator and the participants. neither the participant nor the investigator could be blinded
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    titanium mesh
    Arm Type
    Active Comparator
    Arm Description
    using non resorbable titanium mesh to fix and cover the onlay bone graft mixture to the atrophic maxillary ridge.
    Arm Title
    collagen membrane(Sausage technique)
    Arm Type
    Experimental
    Arm Description
    using resorbable collagen membrane with the sausage technique to fix the onlay bone graft mixture to the resorbed atrophic maxillary ridge
    Intervention Type
    Procedure
    Intervention Name(s)
    titanium mesh
    Intervention Description
    the non resorbable titanium mesh is used to fix the 1:1 mixture of autograft and xenograft particulate bone on the severely atrophies maxillary ridge.
    Intervention Type
    Procedure
    Intervention Name(s)
    collagen membrane (Sausage technique)
    Intervention Description
    the resorbable collagen membrane is used to fix the 1:1 mixture of autograft and xenograft particulate bone on the severely atrophies maxillary ridge.
    Primary Outcome Measure Information:
    Title
    membrane exposure
    Description
    clinical postoperative complications as flap dehiscence and membrane exposure into the oral cavity, its a binary outcome (yes/No) examined and recorded by the investigator.
    Time Frame
    within 3 weeks
    Title
    infection
    Description
    suppuration collection related to the membrane and flap, its a binary outcome (yes/No) examined and recorded by the investigator.
    Time Frame
    10 days
    Title
    inflammation
    Description
    redness and tenderness of the flap, its a binary outcome (yes/No) examined and recorded by the investigator.
    Time Frame
    10 days
    Secondary Outcome Measure Information:
    Title
    bone width gain
    Description
    the amount of bone gained( in millimeter) after augmentation compared to the initial ridge thickness measured clinically using a caliper 2 mm below the crest of the ridge, and radiographically using the Planmeca Promax 3D CBCT unit which will be viewed on planmeca romexis software to calculate the measures needed in millimeter by the outcome assessor.
    Time Frame
    at 6 months
    Title
    bone quality
    Description
    histomorphometric analysis of the bone biopsy taken from the augmented bone to show the quality of the formed bone and the percentage of every type of tissue formed in the specimen taken( unit is area percentage %)
    Time Frame
    at 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients with horizontal atrophied maxillary ridge (thin ridge) less than 4mm. All ages and both sexes were included in this study. Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome. Patients with physical and psychological tolerance Exclusion Criteria: Patients with high risk systemic diseases like uncontrolled diabetes mellitus. As uncontrolled diabetes mellitus has a negative impact on normal bone healing. 8 Heavy smokers.4 Alcohol or drug abuse Gingival bleeding or full mouth plaque index ≥ 25%.4 Patients with physical and psychological intolerance. As psychological stress will affect the immune system and patient's fitness including healing capacity. 9 Unavailability for regular follow-ups

    12. IPD Sharing Statement

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