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

About this trial
This is an interventional treatment trial for Periodontitis
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.
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
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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