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

Sponsor

University of Baghdad (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05389059

Collaborator

(none)

Enrollment

Location

Arms

16.2

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gingival Diseases Traumatic Injury	Procedure: CAF+CM Procedure: I-PRF	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Apr 25, 2022

Anticipated Primary Completion Date :

Mar 30, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.
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).
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Baghdad / College of Dentistry	Baghdad		Iraq	10047

Sponsors and Collaborators

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