The Effect of (L-PRF) Membrane in The Treatment of Gingival Recession

Localized Gingival Recession Clinical Trial

Official title:

The Effect of Leukocyte Platelet Rich Fibrin(L-PRF) Membrane in The Treatment of Localized Gingival Recession (Randomized Controlled Clinical Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04224935
• Other study ID #: 453
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: January 1, 2020

Study information

• Verified date: November 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

evaluation of the use of L-PRF membrane with coronally repositioned flap in treatment of localized gingival recession (Class I & II) in comparison with the use of connective tissue graft

Description:

Twenty patients, who are candidates for gingival recession coverage, will participate in this prospective clinical trial. Group 1(10 patients) : Coronally repositioned flap will be done and L PRF membrane will be placed into the tissues Group 2 (Control group)(10 patients) : Coronally repositioned flap will be done with sub epithelial connective tissue Parameters - Clinical evaluation of percentage of root coverage and keratinized tissue width - Esthetic outcome evaluation Will be done using the root coverage esthetic score (Cairo et al. 2009) that include Both evaluations will be done at 3, 6 and 9 months

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Systemically free patients (American Society of Anesthesiologists I; ASA I).
• Age range (20 -40) years.
• Good compliance with the plaque control instructions following initial therapy.
• Patients diagnosed with Miller class I or II in anterior and premolar teeth
• Availability for follow up and maintenance program.

Exclusion Criteria:

• Patient suffering from periodontitis
• Presence of smoking habit.
• Presence of occlusion interference.
• Pregnant and lactating females.
• Vulnerable group of patients (handicapped, mentally retarded and prisoners).

Related Conditions & MeSH terms

• Gingival Recession
• Localized Gingival Recession

Intervention

Procedure:
• Leukocyte Platelet rich fibrin membrane
the use of Leukocyte Platelet rich fibrin as grafting materials for treatment of recession

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recession treatment	2-Esthetic outcome evaluation was done using Root coverage esthetic score (RES) system ( Cairo et al. 2009) the RES include the following parameters; • Level of the gingival margin (GM):(minimum) Zero points = failure of root coverage (gingival margin apical or equal to the baseline recession); 3 points = partial root coverage;(maximum) 6 points = CRC.	9 months
Secondary	soft tissue thickness (Volumetric assessment)	Preoperatively a cast was made and scanned. At 9 months after surgical procedure the same procedure was done to determine the soft tissue thickness after the surgery. The difference between the tissue thickness before and after was used to determine the efficacy of the different surgical grafting materials used.	9 months