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

Not Applicable

• Conditions: Gingival Diseases; Traumatic Injury
• Interventions: Procedure: CAF+CM; Procedure: I-PRF

• Registration Number: NCT05389059
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-24
• Study Start: 2022-04-25
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-20
• Last Update Submitted: 2022-05-20
• Study First Posted: 2022-05-24
• Last Update Posted: 2022-05-24
• Primary Completion: 2023-03-30
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control arm	CAF+CM	Patients with Gingival recessions are type 1 recession RT1 (cairo et al,2011) which correspond to Miller I\&II gingival recession.
Experimental arm	I-PRF	Patients with Gingival recessions are type 1 recession RT1 (cairo et al,2011) which correspond to Miller I\&II gingival recession.
Experimental arm	CAF+CM	Patients with Gingival recessions are type 1 recession RT1 (cairo et al,2011) which correspond to Miller I\&II gingival recession.

Primary Outcome Measures

Name	Time	Method
Reduction in gingival recession depth on the buccal sides of type one gingival recessionRT1	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

Name	Time	Method
Improvement in Gingival Thickness (GT)	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.
Reduction in the Recession Width (RW)	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.
Reduction in Probing Pocket Depth (PPD)	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.
Reduction Clinical Attachment Level (CAL)	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.
Improvement in the Keratinized Tissue Height (KTH)	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).
Measuring Plaque-Index (PI)	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.
Measuring Bleeding On Probing (BOP)	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.

Trial Locations

Locations (1)

University of Baghdad / College of Dentistry; 🇮🇶 Baghdad, Iraq