Evaluation of Sticky Bone With or Without EDTA for Treatment of Gingival Recession
Primary Purpose
Gingival Recession
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Sticky bone and EDTA
Sticky bone
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession focused on measuring i-PRF, EDTA
Eligibility Criteria
Inclusion Criteria:
- Miller I/II isolated maxillary recession defects.
- No abrasion, caries, or cervical restorations and presence of identifiable cementoenamel junction (CEJ).
- No occlusal interferences.
- Full-mouth plaque index (PI) and gingival index (GI) scores of < 1.
- Non-smokers.
Exclusion Criteria:
- Pregnant patients
- Presence of systemic disease or taking medication that interfere with periodontium
Sites / Locations
- Faculty of Dentistry, Kafrelsheikh UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
sticky bone and EDTA
Sticky bone
Arm Description
treatment of gingival recession using sticky bone after root surface biomodification with EDTA
treatment of gingival recession using sticky bone
Outcomes
Primary Outcome Measures
clinical evaluation of root coverage
the percentage of root coverage will be calculated in millimeter
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04980066
Brief Title
Evaluation of Sticky Bone With or Without EDTA for Treatment of Gingival Recession
Official Title
Evaluation of Sticky Bone With or Without EDTA Root Surface Biomodification for Treatment of Gingival Recession: Randomized Controlled Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 3, 2021 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kafrelsheikh University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Gingival recession is a common clinical finding in periodontal disease which is frequently associated with esthetic concerns, root hypersensitivity, and root caries. Many surgical therapeutic approaches have been developed to predictably obtain root coverage of gingival recession defects. Injectable PRF (I-PRF) is the liquid form of PRF. I-PRF is a bioactive agent obtained by low-speed centrifugation, and it has the capacity to stimulate tissue regeneration. At high concentrations, PRF may stimulate the secretion of several growth factors and trigger fibroblast migration. I-PRF is generally used in regenerative treatments, with good outcomes. Ethylenediaminetetraaceti acid (EDTA) is a chelating agent that could enhance the attachment of connective tissue to the root surface by exposing collagen and, as a consequence, enhance root coverage. EDTA works at neutral pH, and this property has been reported to preserve adjacent tissue vitality. The present study will be carried out to evaluate the effect of sticky bone with or without EDTA root surface biomodification for treatment of gingival recession.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
i-PRF, EDTA
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
sticky bone and EDTA
Arm Type
Experimental
Arm Description
treatment of gingival recession using sticky bone after root surface biomodification with EDTA
Arm Title
Sticky bone
Arm Type
Active Comparator
Arm Description
treatment of gingival recession using sticky bone
Intervention Type
Procedure
Intervention Name(s)
Sticky bone and EDTA
Intervention Description
treatment using Sticky bone after EDTA root surface biomodification
Intervention Type
Procedure
Intervention Name(s)
Sticky bone
Intervention Description
treatment using Sticky bone
Primary Outcome Measure Information:
Title
clinical evaluation of root coverage
Description
the percentage of root coverage will be calculated in millimeter
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Miller I/II isolated maxillary recession defects.
No abrasion, caries, or cervical restorations and presence of identifiable cementoenamel junction (CEJ).
No occlusal interferences.
Full-mouth plaque index (PI) and gingival index (GI) scores of < 1.
Non-smokers.
Exclusion Criteria:
Pregnant patients
Presence of systemic disease or taking medication that interfere with periodontium
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dalia R Issa, PhD
Phone
01007753636
Ext
002
Email
dalia_rasheed@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dalia R Issa, PhD
Organizational Affiliation
Kafrelsheikh University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry, Kafrelsheikh University
City
Kafr El-sheikh
ZIP/Postal Code
33511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dalia R Issa, PhD
Phone
01007753636
Ext
002
Email
dalia_rasheed@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Sticky Bone With or Without EDTA for Treatment of Gingival Recession
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