Back to resultsThe Effect of (L-PRF) Membrane in The Treatment of Gingival Recession
Primary Purpose
Localized Gingival Recession
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Leukocyte Platelet rich fibrin membrane
Sponsored by
About this trial
This is an interventional treatment trial for Localized Gingival Recession
Eligibility Criteria
Inclusion Criteria:
- Systemically free patients (American Society of Anesthesiologists I; ASA I).
- Age range (20 -40) years.
- Good compliance with the plaque control instructions following initial therapy.
- Patients diagnosed with Miller class I or II in anterior and premolar teeth
- Availability for follow up and maintenance program.
Exclusion Criteria:
- Patient suffering from periodontitis
- Presence of smoking habit.
- Presence of occlusion interference.
- Pregnant and lactating females.
- Vulnerable group of patients (handicapped, mentally retarded and prisoners).
Sites / Locations
- Faculty of Dentistry Ain Shams University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Leukocyte Platelet Rich Fibrin
connective tissue
Arm Description
Leukocyte Platelet Rich Fibrin will be used
connective tissue will be used
Outcomes
Primary Outcome Measures
recession treatment
2-Esthetic outcome evaluation was done using Root coverage esthetic score (RES) system ( Cairo et al. 2009) the RES include the following parameters
• Level of the gingival margin (GM):(minimum) Zero points = failure of root coverage (gingival margin apical or equal to the baseline recession); 3 points = partial root coverage;(maximum) 6 points = CRC.
Secondary Outcome Measures
soft tissue thickness (Volumetric assessment)
Preoperatively a cast was made and scanned. At 9 months after surgical procedure the same procedure was done to determine the soft tissue thickness after the surgery. The difference between the tissue thickness before and after was used to determine the efficacy of the different surgical grafting materials used.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04224935
Brief Title
The Effect of (L-PRF) Membrane in The Treatment of Gingival Recession
Official Title
The Effect of Leukocyte Platelet Rich Fibrin(L-PRF) Membrane in The Treatment of Localized Gingival Recession (Randomized Controlled Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
January 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams 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
evaluation of the use of L-PRF membrane with coronally repositioned flap in treatment of localized gingival recession (Class I & II) in comparison with the use of connective tissue graft
Detailed Description
Twenty patients, who are candidates for gingival recession coverage, will participate in this prospective clinical trial.
Group 1(10 patients) :
Coronally repositioned flap will be done and L PRF membrane will be placed into the tissues
Group 2 (Control group)(10 patients) :
Coronally repositioned flap will be done with sub epithelial connective tissue Parameters
Clinical evaluation of percentage of root coverage and keratinized tissue width
Esthetic outcome evaluation Will be done using the root coverage esthetic score (Cairo et al. 2009) that include
Both evaluations will be done at 3, 6 and 9 months
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Localized Gingival Recession
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Leukocyte Platelet Rich Fibrin
Arm Type
Active Comparator
Arm Description
Leukocyte Platelet Rich Fibrin will be used
Arm Title
connective tissue
Arm Type
Active Comparator
Arm Description
connective tissue will be used
Intervention Type
Procedure
Intervention Name(s)
Leukocyte Platelet rich fibrin membrane
Other Intervention Name(s)
sub epithelial connective tissue
Intervention Description
the use of Leukocyte Platelet rich fibrin as grafting materials for treatment of recession
Primary Outcome Measure Information:
Title
recession treatment
Description
2-Esthetic outcome evaluation was done using Root coverage esthetic score (RES) system ( Cairo et al. 2009) the RES include the following parameters
• Level of the gingival margin (GM):(minimum) Zero points = failure of root coverage (gingival margin apical or equal to the baseline recession); 3 points = partial root coverage;(maximum) 6 points = CRC.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
soft tissue thickness (Volumetric assessment)
Description
Preoperatively a cast was made and scanned. At 9 months after surgical procedure the same procedure was done to determine the soft tissue thickness after the surgery. The difference between the tissue thickness before and after was used to determine the efficacy of the different surgical grafting materials used.
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Systemically free patients (American Society of Anesthesiologists I; ASA I).
Age range (20 -40) years.
Good compliance with the plaque control instructions following initial therapy.
Patients diagnosed with Miller class I or II in anterior and premolar teeth
Availability for follow up and maintenance program.
Exclusion Criteria:
Patient suffering from periodontitis
Presence of smoking habit.
Presence of occlusion interference.
Pregnant and lactating females.
Vulnerable group of patients (handicapped, mentally retarded and prisoners).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ahmed abdel aziz, co professor
Organizational Affiliation
faculty of dentistry ain shams university
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Dentistry Ain Shams University
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of (L-PRF) Membrane in The Treatment of Gingival Recession
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