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Injectable Platelet Rich Fibrin With Collagen Matrix in Treatment of Multiple Gingival Recession.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05389059
Recruitment Status : Enrolling by invitation
First Posted : May 24, 2022
Last Update Posted : May 24, 2022
Sponsor:
Information provided by (Responsible Party):
Basima Ghaffoori Ali, University of Baghdad

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.

Condition or disease Intervention/treatment Phase
Gingival Diseases Traumatic Injury Procedure: CAF+CM Procedure: I-PRF Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Value of Injectable Platelet Rich Fibrin With Volume Stable Collagen Matrix in Treatment of Multiple Gingival Recession; a Randomized Clinical Trial.
Actual Study Start Date : April 25, 2022
Estimated Primary Completion Date : March 30, 2023
Estimated Study Completion Date : September 1, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arm Intervention/treatment
Control arm
Patients with Gingival recessions are type 1 recession RT1 (cairo et al,2011) which correspond to Miller I&II gingival recession.
Procedure: CAF+CM
Periodontal surgery including CAF+CM application

Experimental arm
Patients with Gingival recessions are type 1 recession RT1 (cairo et al,2011) which correspond to Miller I&II gingival recession.
Procedure: CAF+CM
Periodontal surgery including CAF+CM application

Procedure: I-PRF
Periodontal surgery including CAF+CM application with i-PRF




Primary Outcome Measures :
  1. Reduction in gingival recession depth on the buccal sides of type one gingival recessionRT1 [ Time Frame: Between the baseline preoperative measurement and follow-up at 3 months and 6 months ]
    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 :
  1. Improvement in Gingival Thickness (GT) [ Time Frame: Between the baseline preoperative measurement and follow-up at 3 months and 6 months ]
    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.

  2. Improvement in the Keratinized Tissue Height (KTH) [ Time Frame: Between the baseline preoperative measurement and follow-up at 3 months and 6 months ]
    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).

  3. Reduction in the Recession Width (RW) [ Time Frame: Between the baseline preoperative measurement and follow-up at 3 months and 6 months ]
    Recession Width (RW) is measured in millimeter (mm) at the Cement-Enamel Junction (CEJ) using UNC-15 probe.

  4. Reduction in Probing Pocket Depth (PPD) [ Time Frame: Between the baseline preoperative measurement and follow-up at 3 months and 6 months ]
    Probing Pocket Depth (PPD) is measured in millimeter (mm) from the gingival margin to the apical extend of the probe.

  5. Reduction Clinical Attachment Level (CAL) [ Time Frame: Between the baseline preoperative measurement and follow-up at 3 months and 6 months ]
    Clinical Attachment Level (CAL) is measured in millimeter (mm) from the CEJ to the apical extend of the probe.

  6. Measuring Plaque-Index (PI) [ Time Frame: Between the baseline preoperative measurement and follow-up at 3 months and 6 months ]
    Plaque-Index (PI) is measured as a percentage of the presence of Plaque on four surfaces of the teeth using a manual periodontal probe.

  7. Measuring Bleeding On Probing (BOP) [ Time Frame: Between the baseline preoperative measurement and follow-up at 3 months and 6 months ]
    Bleeding On Probing (BOP) is measured as a percentage of sites with bleeding on probing using a manual periodontal probe.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05389059


Locations
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Iraq
University of Baghdad / College of Dentistry
Baghdad, Iraq, 10047
Sponsors and Collaborators
University of Baghdad
Investigators
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Principal Investigator: Basima Gh Ali, MSc University of Baghdad / College of Dentistry
Study Director: Thair AL Hassan, PHD University of Baghdad / College of Dentistry
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Responsible Party: Basima Ghaffoori Ali, PHD student, University of Baghdad
ClinicalTrials.gov Identifier: NCT05389059    
Other Study ID Numbers: 519622
First Posted: May 24, 2022    Key Record Dates
Last Update Posted: May 24, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Basima Ghaffoori Ali, University of Baghdad:
Gingival Recession
Collagen Matrix
Plasma rich proten
Additional relevant MeSH terms:
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Gingival Recession
Gingival Diseases
Wounds and Injuries
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy