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Periodontal Osseous Wall Piezosplitting and EDTA Root Surface Etching

Primary Purpose

Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
bone swaging
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. good compliance with plaque control instructions following initial therapy
  2. teeth involved were all vital with no mobility ;
  3. each subject contributed a single predominately 2 or 3-wall intrabony interproximal defect around premolar or molar teeth without furcation involvement;

Exclusion Criteria:

  1. no systemic diseases which could influence the outcome of therapy;
  2. absence of periodontal treatment during the previous year.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    bone swaging alone

    bone swaging plus EDTA

    Arm Description

    xenograft alone

    bone swaging with EDTA

    Outcomes

    Primary Outcome Measures

    Radiographic evaluation
    removing the defect as seen in radiograph defect filling with bone swaging with edta and bone substitute

    Secondary Outcome Measures

    Clinical pocket depth
    By periodontal prob to measure the clinical parameter

    Full Information

    First Posted
    August 1, 2018
    Last Updated
    February 13, 2023
    Sponsor
    Al-Azhar University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03670979
    Brief Title
    Periodontal Osseous Wall Piezosplitting and EDTA Root Surface Etching
    Official Title
    A Novel Approach of Periodontal Osseous Wall Piezosplitting and EDTA Root Surface Etching in Management of Localized Intrabony Defects With Wide Angulation. Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    January 5, 2016 (Actual)
    Primary Completion Date
    January 5, 2017 (Actual)
    Study Completion Date
    January 5, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Al-Azhar 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 study was designed to investigate the use of minimally invasive Piezo knife to harvest vascularized interceptal bone pedicle in treating intrabony defects.
    Detailed Description
    Sixteen non-smoking patients with severe chronic periodontitis participated in this prospective, randomized clinical study. Patients were randomly assigned into one of a 2 groups (8 patients each): bone substitute grafting of the intrabony defect, control group (Gr1), intrabony defect osseous wall swaging (OWS) combined xenograft (Gr2). In both groups root surfaces where treated with a neutral 24% EDTA gel and saline irrigation. Clinical and radiographic measurements were reassessed at 6 months after surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    16 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    bone swaging alone
    Arm Type
    Experimental
    Arm Description
    xenograft alone
    Arm Title
    bone swaging plus EDTA
    Arm Type
    Experimental
    Arm Description
    bone swaging with EDTA
    Intervention Type
    Procedure
    Intervention Name(s)
    bone swaging
    Intervention Description
    osseous wall pedicle was placed to treat the infrabony defect by autogrnous bone
    Primary Outcome Measure Information:
    Title
    Radiographic evaluation
    Description
    removing the defect as seen in radiograph defect filling with bone swaging with edta and bone substitute
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Clinical pocket depth
    Description
    By periodontal prob to measure the clinical parameter
    Time Frame
    3month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: good compliance with plaque control instructions following initial therapy teeth involved were all vital with no mobility ; each subject contributed a single predominately 2 or 3-wall intrabony interproximal defect around premolar or molar teeth without furcation involvement; Exclusion Criteria: no systemic diseases which could influence the outcome of therapy; absence of periodontal treatment during the previous year.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    ahmed y gamal, professor
    Organizational Affiliation
    Ain Shams University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    institutional review board, egypt

    Learn more about this trial

    Periodontal Osseous Wall Piezosplitting and EDTA Root Surface Etching

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