Back to resultsInjectable Platelet Rich Fibrin With Collagen Matrix in Treatment of Multiple Gingival Recession.
Primary Purpose
Gingival Diseases, Traumatic Injury
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
CAF+CM
I-PRF
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Diseases focused on measuring Gingival Recession, Collagen Matrix, Plasma rich proten
Eligibility Criteria
Inclusion Criteria:
- Presence of at least two localized gingival recessions on either sides of the maxilla and/or mandible excluding molar region.
- The cemento-enamel junction (CEJ) is visible in the teeth for root coverage procedures.
- All recessions are type 1recession RT1 (cairo et al,2011) which correspond to Miller I&II gingival recession
- All patients must demonstrate adequate plaque control with a fullmouth plaque score less than 20% and with .
- All patients at least 18 years of age and of both genders.
Exclusion Criteria:
- Smoker Patients .
- Patients with diabetes.
- Patients with a history of malignancy, radiotherapy, or chemotherapy for malignancy.
- pregnant or nursing women.
- Patients taking medications or having treatments with an effect on mucosal healing in general (e.g. steroids, large doses of antiinflammatory drugs).
- Patients with a disease affecting connective tissue metabolism.
- Patients allergic to collagen.
Sites / Locations
- University of Baghdad / College of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Control arm
Experimental arm
Arm Description
Patients with Gingival recessions are type 1 recession RT1 (cairo et al,2011) which correspond to Miller I&II gingival recession.
Patients with Gingival recessions are type 1 recession RT1 (cairo et al,2011) which correspond to Miller I&II gingival recession.
Outcomes
Primary Outcome Measures
Reduction in gingival recession depth on the buccal sides of type one gingival recessionRT1
The primary outcome of the study is the reduction in gingival recession depth on the buccal sides of RT1 gingival recession, between the baseline preoperative measurement and follow-up at 3 months and 6 months. The Recession Depth (RD) is Measured in millimeter (mm) from CEJ (Cemento-Enamel-Junction) to the gingival margin using UNC-15 probe.
Secondary Outcome Measures
Improvement in Gingival Thickness (GT)
Gingival Thickness (GT) is determined at 1.5 mm apical to the gingival margin using a caliper (endodontic reamer#20) rounded to the nearest 0.1mm.
Improvement in the Keratinized Tissue Height (KTH)
Keratinized Tissue Height (KTH) is measured in millimeters (mm) taken at the mid buccal aspect of the involved teeth from the gingival margin to the muco-gingival junction, by a manual periodontal probe (UNC-15 probe,Hu-Friedy,Chicago,USA).
Reduction in the Recession Width (RW)
Recession Width (RW) is measured in millimeter (mm) at the Cement-Enamel Junction (CEJ) using UNC-15 probe.
Reduction in Probing Pocket Depth (PPD)
Probing Pocket Depth (PPD) is measured in millimeter (mm) from the gingival margin to the apical extend of the probe.
Reduction Clinical Attachment Level (CAL)
Clinical Attachment Level (CAL) is measured in millimeter (mm) from the CEJ to the apical extend of the probe.
Measuring Plaque-Index (PI)
Plaque-Index (PI) is measured as a percentage of the presence of Plaque on four surfaces of the teeth using a manual periodontal probe.
Measuring Bleeding On Probing (BOP)
Bleeding On Probing (BOP) is measured as a percentage of sites with bleeding on probing using a manual periodontal probe.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05389059
Brief Title
Injectable Platelet Rich Fibrin With Collagen Matrix in Treatment of Multiple Gingival Recession.
Official Title
The Value of Injectable Platelet Rich Fibrin With Volume Stable Collagen Matrix in Treatment of Multiple Gingival Recession; a Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 25, 2022 (Actual)
Primary Completion Date
March 30, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Baghdad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
This study is proposing the use of i-PRF clot as a scaffold for the XCM in order to obtain a novel biomaterial, incorporating active growth factors and collagen matrix in a single framework, based on the potential effect of i-PRF to enhance fibroblast activity and angiogenesis stimulation for treatment of multiple gingival recession.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Diseases, Traumatic Injury
Keywords
Gingival Recession, Collagen Matrix, Plasma rich proten
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control arm
Arm Type
Other
Arm Description
Patients with Gingival recessions are type 1 recession RT1 (cairo et al,2011) which correspond to Miller I&II gingival recession.
Arm Title
Experimental arm
Arm Type
Other
Arm Description
Patients with Gingival recessions are type 1 recession RT1 (cairo et al,2011) which correspond to Miller I&II gingival recession.
Intervention Type
Procedure
Intervention Name(s)
CAF+CM
Intervention Description
Periodontal surgery including CAF+CM application
Intervention Type
Procedure
Intervention Name(s)
I-PRF
Intervention Description
Periodontal surgery including CAF+CM application with i-PRF
Primary Outcome Measure Information:
Title
Reduction in gingival recession depth on the buccal sides of type one gingival recessionRT1
Description
The primary outcome of the study is the reduction in gingival recession depth on the buccal sides of RT1 gingival recession, between the baseline preoperative measurement and follow-up at 3 months and 6 months. The Recession Depth (RD) is Measured in millimeter (mm) from CEJ (Cemento-Enamel-Junction) to the gingival margin using UNC-15 probe.
Time Frame
Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Secondary Outcome Measure Information:
Title
Improvement in Gingival Thickness (GT)
Description
Gingival Thickness (GT) is determined at 1.5 mm apical to the gingival margin using a caliper (endodontic reamer#20) rounded to the nearest 0.1mm.
Time Frame
Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Title
Improvement in the Keratinized Tissue Height (KTH)
Description
Keratinized Tissue Height (KTH) is measured in millimeters (mm) taken at the mid buccal aspect of the involved teeth from the gingival margin to the muco-gingival junction, by a manual periodontal probe (UNC-15 probe,Hu-Friedy,Chicago,USA).
Time Frame
Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Title
Reduction in the Recession Width (RW)
Description
Recession Width (RW) is measured in millimeter (mm) at the Cement-Enamel Junction (CEJ) using UNC-15 probe.
Time Frame
Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Title
Reduction in Probing Pocket Depth (PPD)
Description
Probing Pocket Depth (PPD) is measured in millimeter (mm) from the gingival margin to the apical extend of the probe.
Time Frame
Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Title
Reduction Clinical Attachment Level (CAL)
Description
Clinical Attachment Level (CAL) is measured in millimeter (mm) from the CEJ to the apical extend of the probe.
Time Frame
Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Title
Measuring Plaque-Index (PI)
Description
Plaque-Index (PI) is measured as a percentage of the presence of Plaque on four surfaces of the teeth using a manual periodontal probe.
Time Frame
Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Title
Measuring Bleeding On Probing (BOP)
Description
Bleeding On Probing (BOP) is measured as a percentage of sites with bleeding on probing using a manual periodontal probe.
Time Frame
Between the baseline preoperative measurement and follow-up at 3 months and 6 months
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:
Presence of at least two localized gingival recessions on either sides of the maxilla and/or mandible excluding molar region.
The cemento-enamel junction (CEJ) is visible in the teeth for root coverage procedures.
All recessions are type 1recession RT1 (cairo et al,2011) which correspond to Miller I&II gingival recession
All patients must demonstrate adequate plaque control with a fullmouth plaque score less than 20% and with .
All patients at least 18 years of age and of both genders.
Exclusion Criteria:
Smoker Patients .
Patients with diabetes.
Patients with a history of malignancy, radiotherapy, or chemotherapy for malignancy.
pregnant or nursing women.
Patients taking medications or having treatments with an effect on mucosal healing in general (e.g. steroids, large doses of antiinflammatory drugs).
Patients with a disease affecting connective tissue metabolism.
Patients allergic to collagen.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Basima Gh Ali, MSc
Organizational Affiliation
University of Baghdad
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thair AL Hassan, PHD
Organizational Affiliation
University of Baghdad
Official's Role
Study Director
Facility Information:
Facility Name
University of Baghdad / College of Dentistry
City
Baghdad
ZIP/Postal Code
10047
Country
Iraq
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Injectable Platelet Rich Fibrin With Collagen Matrix in Treatment of Multiple Gingival Recession.
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