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

Gingival Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05389059
• Other study ID #: 519622
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 25, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: May 2022
• Source: University of Baghdad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: September 1, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gingival Diseases
• Gingival Recession
• Traumatic Injury
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Iraq	University of Baghdad / College of Dentistry	Baghdad

Sponsors (1)

Lead Sponsor	Collaborator
University of Baghdad

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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