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

The Value of Injectable Platelet Rich Fibrin With Volume Stable Collagen Matrix in Treatment of Multiple Gingival Recession; a Randomized Clinical Trial.

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Gingival Diseases; Traumatic Injury
• Intervention / Treatment: Procedure: CAF+CM; Procedure: I-PRF

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • Baghdad, Iraq, 10047
    • University of Baghdad / College of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Between the baseline preoperative measurement and follow-up at 3 months and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Between the baseline preoperative measurement and follow-up at 3 months and 6 months
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).	Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Reduction in the Recession Width (RW)	Recession Width (RW) is measured in millimeter (mm) at the Cement-Enamel Junction (CEJ) using UNC-15 probe.	Between the baseline preoperative measurement and follow-up at 3 months and 6 months
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.	Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Reduction Clinical Attachment Level (CAL)	Clinical Attachment Level (CAL) is measured in millimeter (mm) from the CEJ to the apical extend of the probe.	Between the baseline preoperative measurement and follow-up at 3 months and 6 months
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.	Between the baseline preoperative measurement and follow-up at 3 months and 6 months
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.	Between the baseline preoperative measurement and follow-up at 3 months and 6 months

Collaborators and Investigators

• Sponsor: University of Baghdad
• Investigators: Principal Investigator: Basima Gh Ali, MSc, university of Baghdad, college of dentistry; Study Director: Thair AL Hassan, PHD, university of Baghdad, college of dentistry

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2022
• Primary Completion (Anticipated): March 30, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: April 24, 2022
• First Submitted That Met QC Criteria: May 20, 2022
• First Posted (Actual): May 24, 2022

Study Record Updates

• Last Update Posted (Actual): May 24, 2022
• Last Update Submitted That Met QC Criteria: May 20, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Gingival Recession; Collagen Matrix; Plasma rich proten
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontal Atrophy; Wounds and Injuries; Gingival Recession; Gingival Diseases
• Other Study ID Numbers: 519622

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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