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Demineralized Dentin Graft With Hydrochloric Acid Versus Nitric Acid in Alveolar Ridge Preservation (DDG)

Primary Purpose

Alveolar Bone Loss

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Alveolar ridge preservation after extraction
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

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Non-restorable teeth
  • medically healthy
  • able to provide informed consent and attend follow-up period

Exclusion Criteria:

  • pregnant
  • smokers or alcoholic
  • severe bone loss

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    autogenous dentin graft treated with nitric acid

    autogenous dentin graft treated with hydrochloric acid

    Arm Description

    Outcomes

    Primary Outcome Measures

    Radiographic bone changes
    width and height losses (quantitative in mm)

    Secondary Outcome Measures

    histological analysis
    Histologic observations (qualitative) and histomorphometric measurements (quantitative in %)
    soft tissue healing
    rate of wound epitheliallization

    Full Information

    First Posted
    May 14, 2020
    Last Updated
    July 13, 2020
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04393714
    Brief Title
    Demineralized Dentin Graft With Hydrochloric Acid Versus Nitric Acid in Alveolar Ridge Preservation
    Acronym
    DDG
    Official Title
    Demineralized Dentin Graft With Hydrochloric Acid Versus Nitric Acid in Alveolar Ridge Preservation. Randomised Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2020 (Anticipated)
    Primary Completion Date
    August 31, 2021 (Anticipated)
    Study Completion Date
    October 31, 2021 (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
    The reduction in alveolar bone dimensions is an inevitable outcome after tooth extraction due to the healing events that results in bone modeling/remodeling. Alveolar ridge preservation is a successful approach that aids in reducing these changes greatly. Various techniques have been employed to achieve that outcome utilizing bone grafts and/or membrane. Dentin graft is a promising type that can overcome many of the limitations facing mainstream grafts. Autogenous source serve the advantage of providing graft with no cross-infection risk or immunogenicity. Moreover, the unique structure of dentin makes it suitable for osteoinduction and osteoconduction that yields favorite bone regeneration outcomes. Demineralization of dentin is essential to release trapped growth factors, expose collagen fibrils and enhance the grafts degradability and replacement by native tissues. Many acids have been investigated for the use in chairside preparation of the dentin graft and hence, clinicians are faced with different choices but little evidence regarding the acid which yield s better outcomes.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Split-mouth prospective randomized clinical trial with 1:1 assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    8 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    autogenous dentin graft treated with nitric acid
    Arm Type
    Experimental
    Arm Title
    autogenous dentin graft treated with hydrochloric acid
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    Alveolar ridge preservation after extraction
    Intervention Description
    atraumatic extraction followed by graft material insertion
    Primary Outcome Measure Information:
    Title
    Radiographic bone changes
    Description
    width and height losses (quantitative in mm)
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    histological analysis
    Description
    Histologic observations (qualitative) and histomorphometric measurements (quantitative in %)
    Time Frame
    6 months
    Title
    soft tissue healing
    Description
    rate of wound epitheliallization
    Time Frame
    Biweekly for 6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Non-restorable teeth medically healthy able to provide informed consent and attend follow-up period Exclusion Criteria: pregnant smokers or alcoholic severe bone loss

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Demineralized Dentin Graft With Hydrochloric Acid Versus Nitric Acid in Alveolar Ridge Preservation

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