Extended Platelet- Rich Fibrin Membrane Combined With Vestibular Incision Subperiosteal Tunnel Access Technique to Treat Localized Gingival Recession

NCT07079293 | Completed

• 1 other identifier: A0801024OM
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be performed to clinically evaluate and compare the effectiveness of extended platelet-rich fibrin (e-PRF) membrane versus de-epithelized free gingival graft (DFGG) in combination with vestibular incision subperiosteal tunnel access (VISTA) in the treatment of localized Cairo gingival recession type 1 (RT1) defects. The primary outcome of the present study will be the percentage of root coverage assessed after 6 months of surgical therapy whereas the secondary outcomes include the differences of gingival thickness, keratinized tissue width and dental hypersensitivity after 3 and 6 months.

Conditions

Gingival Recession, Localized

Keywords

CTG; alb prf; extended prf; e prf; G.REC; VISTA; RT1; CAIRO

Outcome Measures

Primary Outcomes (1)

• Root coverage percentage (RC%)

  Root coverage percentage (%)

  6 months

Secondary Outcomes (3)

• Gingival thickness (GT)

  6 months

• Width of keratinized gingiva (WKG):

  6 months

• Sensitivity visual analogue scale (Sens VAS)

  6 months

Study Arms (2)

Group I (control group): Connective Tissue Graft to treat patient had RT1 Gingival Recession

EXPERIMENTAL

15 patients will be treated with free gingival graft harvested from the hard palate then de-epithelized outside the oral cavity to be used in conjunction with VISTA technique for treatment of type 1 recession (RT1).

Procedure: Harvesting of Free Gingival Graft and preparation of CTG; Procedure: VISTA technique

Group 2 (study group): Alb prf membrane to treat patient had RT1 Gingival Recession

EXPERIMENTAL

15 patients will be treated with extended platelet-rich fibrin (e-PRF) (Alb prf) membrane to be used in conjunction with VISTA technique for treatment of type 1 recession (RT1).

Other: Preparation of Extended PRF; Procedure: VISTA technique

Interventions

Preparation of Extended PRF OTHER

Whole blood (10 mL) will be centrifuged at 700 g for 8 minutes. The upper layer (yellow layer) shows the liquid plasma layer. The most upper layer of platelet- poor plasma (PPP) will be collected in a syringe. then PPP will be heated in a heat block device at 75°C for 10 minutes and thereafter cooled to room temperature for approximately 2 minutes. An injectable albumin gel will then be prepared. Then the liquid platelet-rich layer (liquid-PRF) including the buffy coat layer with accumulated platelets and leukocytes, will be collected in a separate syringe. The albumin gel and native liquid PRF will then be thoroughly mixed by utilizing a female-female luer lock connector. Now injectable e-PRF in final form is ready to be used .

Group 2 (study group): Alb prf membrane to treat patient had RT1 Gingival Recession

Harvesting of Free Gingival Graft and preparation of CTG PROCEDURE

The region distal from the canines, commencing at least 2 mm from the gingival margin with a width of 5-8 mm and a desirable length to cover the entire recipient site is an ideal site for harvesting a FGG from the hard palate for root coverage. Harvesting of FGG is performed as follows: The graft is prepared by outlining with two parallel longitudinal incisions that are interconnected with vertical incisions. Graft deliberation is initiated along the paramarginal incision in a split-thickness fashion with a goal of removing an FGG of 1.5-2-mm thickness without touching the periosteum. The harvested free gingival graft will be de-epithelialized to obtain an DFGG. The donor site wound will be covered by gel foam which will be sutured in place and then healing will occur by secondary intention .

Group I (control group): Connective Tissue Graft to treat patient had RT1 Gingival Recession

VISTA technique PROCEDURE

Following Zadeh's (2011) protocol, under local anesthesia, a vestibular access incision is made depending on the treatment site (midline frenum for maxillary anterior, frenal area between canine and lateral incisor for maxillary posterior, and similar for mandibular regions). The incision passes through the periosteum to create a subperiosteal tunnel exposing the facial bone and root dehiscence. In the test group, the extended platelet-rich fibrin (e-PRF) membrane is inserted into the tunnel and secured to the flap with horizontal sutures; in the control group, a de-epithelialized free gingival graft (DFGG) is used similarly. Each tooth's facial enamel is briefly acid-etched, washed, and dried to attach vicryl sutures fixed with flowable composite resin to prevent apical relapse during healing. Finally, the access incision is closed and sutured with vicryl sutures

Group 2 (study group): Alb prf membrane to treat patient had RT1 Gingival Recession; Group I (control group): Connective Tissue Graft to treat patient had RT1 Gingival Recession

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Cairo recession type 1 (RT1): Gingival recession with no loss of interproximal attachment. Interproximal CEJ is clinically not detectable at both mesial and distal aspects of the tooth (15).
• No systemic diseases.
• Non-smokers.
• Good oral hygiene and no bleeding on probing.
• No history of previous mucogingival surgeries.

You may not qualify if:

• \. Detected interproximal alveolar bone loss.
• \. Pregnancy and lactating females
• \. Heavy smokers.
• \. Immunocompromised patients.
• \. Fixed prosthesis in the site that will be treated.
• \. Teeth with cervical caries, non-carious lesions or cervical fillings.
• \. Bad oral hygiene.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Dentistry, Mansoura University.

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2025
• First Posted: July 23, 2025
• Study Start: April 1, 2024
• Primary Completion: May 20, 2025
• Study Completion: June 20, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-07

Locations

EG (1)