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Autogenous Bone Mixed With Xenograft Versus Xenograft Alone Versus Absorbent Gelatin Sponge

Primary Purpose

Bone Resorption, Alveolar Bone Loss, Alveolar Bone Resorption

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mixture of Autogenous bone & Anorganic Bovine Bone (ABB)
Anorganic Bovine Bone (ABB)
Absorbable gelatin sponge
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

18 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 a 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.
  • Pregnant Females.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    Mixture of Autogenous bone & Anorganic Bovine Bone (ABB)

    Anorganic bovine bone graft (ABB)

    Absorbable gelatin Sponge

    Arm Description

    socket preservation with a mixture of autogenous bone graft acquired at the time of extraction mixed with a 50:50 ratio of Anorganic bovine bone

    filling the extraction socket with ABB graft

    Filling the socket with an absorbable gelatin sponge

    Outcomes

    Primary Outcome Measures

    Histomorphometrical bone analysis
    histological bone core analysis

    Secondary Outcome Measures

    Alveolar Bone marginal loss
    CBCT measurements of marginal bone dimensional difference

    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
    NCT03584984
    Brief Title
    Autogenous Bone Mixed With Xenograft Versus Xenograft Alone Versus Absorbent Gelatin Sponge
    Official Title
    Alveolar Ridge Preservation in Mandibular Molars Using Mixture of Autogenous Bone & Anorganic Bovine Bone (ABB) Versus Anorganic Bovine Bone Alone Versus Absorbent Gelatin Sponge
    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
    January 1, 2019 (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
    Alveolar bone atrophy post-extraction has been well documented in the past years. normal healing event results in a minimal loss of vertical height (around 1 mm), but a substantial loss of width in the buccal-lingual plane (4-6 mm). Alveolar socket preservation is thought to deal with this issue as to prevent the loss of alveolar bone dimensions post extraction in the case of delayed implant placement

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Mixture of Autogenous bone & Anorganic Bovine Bone (ABB)
    Arm Type
    Experimental
    Arm Description
    socket preservation with a mixture of autogenous bone graft acquired at the time of extraction mixed with a 50:50 ratio of Anorganic bovine bone
    Arm Title
    Anorganic bovine bone graft (ABB)
    Arm Type
    Active Comparator
    Arm Description
    filling the extraction socket with ABB graft
    Arm Title
    Absorbable gelatin Sponge
    Arm Type
    Active Comparator
    Arm Description
    Filling the socket with an absorbable gelatin sponge
    Intervention Type
    Procedure
    Intervention Name(s)
    Mixture of Autogenous bone & Anorganic Bovine Bone (ABB)
    Intervention Description
    Filling the socket with Mixing of autogenous bone graft and anorganic bovine bone in a 50:50 ratio
    Intervention Type
    Procedure
    Intervention Name(s)
    Anorganic Bovine Bone (ABB)
    Intervention Description
    Filling the socket with Anorganic bovine bone graft material only
    Intervention Type
    Procedure
    Intervention Name(s)
    Absorbable gelatin sponge
    Intervention Description
    Filling the socket with an absorbable gelatin sponge foam pack
    Primary Outcome Measure Information:
    Title
    Histomorphometrical bone analysis
    Description
    histological bone core analysis
    Time Frame
    6 month post primary surgery
    Secondary Outcome Measure Information:
    Title
    Alveolar Bone marginal loss
    Description
    CBCT measurements of marginal bone dimensional difference
    Time Frame
    6 month post primary surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 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 a 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. Pregnant Females.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dina M. Al-Esawy, Masters
    Phone
    01206036365
    Email
    dr.dina.alesawy@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dina M. Al-Esawy, Masters
    Phone
    01206036565
    Email
    dr.dina.alesawy@hotmail.com

    12. IPD Sharing Statement

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    Autogenous Bone Mixed With Xenograft Versus Xenograft Alone Versus Absorbent Gelatin Sponge

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