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Ridge Preservation In Mandibular Molars Using Mixture Of ABB And Autogenous Particulate VS Sticky Bone

Primary Purpose

Alveolar Bone Loss, Bone Graft Failure, Alveolar Bone Resorption

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ABB And Autogenous Particulate
PRF, ABB & Autogenous Particulate
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alveolar Bone Loss

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adult patients with hopeless mandibular molars indicated for extraction and implant placement in two stages that indicate socket preservation.
  • Both sexes.
  • No intraoral soft and hard tissue pathology.
  • No systemic condition that contraindicate implant placement.

Exclusion Criteria:

  • Presence of fenestrations or dehiscence of the residual bony Walls after extraction.
  • Heavy smokers more than 20 cigarettes per day .(24)
  • Patients with systemic disease that may affect normal healing.
  • Psychiatric problems
  • Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
  • Patients that refuse to be called back for implant placement post extraction.
  • Patients that have exceeded bone resorption surrounding the tooth prior to extraction and require guided bone regeneration.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    PRF , ABB & Autogenous Particulate

    ABB And Autogenous Particulate

    Arm Description

    Platelets rich fibrin + anorganic bovine bone + autogenous particulate graft

    anorganic bovine bone +autogenous particulate graft

    Outcomes

    Primary Outcome Measures

    histomorphometrical bone quality
    histological bone quality measured from a core sample taken from the grafted site

    Secondary Outcome Measures

    marginal bone loss
    alveolar margin bone loss measured be CBCT

    Full Information

    First Posted
    June 29, 2018
    Last Updated
    July 13, 2018
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03584997
    Brief Title
    Ridge Preservation In Mandibular Molars Using Mixture Of ABB And Autogenous Particulate VS Sticky Bone
    Official Title
    Alveolar Ridge Preservation In Mandibular Molars Using Mixture Of Anorganic Bovine Bone(ABB) And Autogenous Particulate VS Mixture Of Injectable Platelets Rich Fibrin, ABB And Autogenous Particulates (Sticky Bone).
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 1, 2018 (Anticipated)
    Primary Completion Date
    December 1, 2018 (Anticipated)
    Study Completion Date
    July 1, 2019 (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
    Histological Measurement Comparing the density of the new bone formed during socket preservation technique using a Mixture of Anorganic Bovine Bone(ABB) And Autogenous Particulate vs a Mixture of Injectable Platelets Rich Fibers, ABB And Autogenous Particulates (sticky bone). radiographical measurements of the amount of bone dimensions changes in socket preservation technique in 6-month period using a Mixture Of Anorganic Bovine Bone(ABB) And Autogenous Particulate vs a Mixture Of Injectable Platelets Rich Fibers, ABB And Autogenous Particulates (sticky bone)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alveolar Bone Loss, Bone Graft Failure, Alveolar Bone Resorption

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PRF , ABB & Autogenous Particulate
    Arm Type
    Experimental
    Arm Description
    Platelets rich fibrin + anorganic bovine bone + autogenous particulate graft
    Arm Title
    ABB And Autogenous Particulate
    Arm Type
    Active Comparator
    Arm Description
    anorganic bovine bone +autogenous particulate graft
    Intervention Type
    Procedure
    Intervention Name(s)
    ABB And Autogenous Particulate
    Intervention Description
    Mixing the autogenous bone graft aquired at the time of surgery with a 50:50 ration of anorganic bovine bone and filling the socket
    Intervention Type
    Procedure
    Intervention Name(s)
    PRF, ABB & Autogenous Particulate
    Intervention Description
    adding an injectable platelets rich fibrin to a Mixture of autogenous bone graft aquired at the time of surgery with a 50:50 ration of anorganic bovine bone and filling the socket
    Primary Outcome Measure Information:
    Title
    histomorphometrical bone quality
    Description
    histological bone quality measured from a core sample taken from the grafted site
    Time Frame
    6 month
    Secondary Outcome Measure Information:
    Title
    marginal bone loss
    Description
    alveolar margin bone loss measured be CBCT
    Time Frame
    6 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Adult patients with hopeless mandibular molars indicated for extraction and implant placement in two stages that indicate socket preservation. Both sexes. No intraoral soft and hard tissue pathology. No systemic condition that contraindicate implant placement. Exclusion Criteria: Presence of fenestrations or dehiscence of the residual bony Walls after extraction. Heavy smokers more than 20 cigarettes per day .(24) Patients with systemic disease that may affect normal healing. Psychiatric problems Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site. Patients that refuse to be called back for implant placement post extraction. Patients that have exceeded bone resorption surrounding the tooth prior to extraction and require guided bone regeneration.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohammed D Darwish, Masters
    Phone
    00201206036565
    Email
    doctorelsayed87@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohammed D Darwish, Masters
    Phone
    00201206036365
    Email
    doctorelsayed87@hotmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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