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Gingival Recession, Localizedalb prf RECNCT07079293

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

A study testing Preparation of Extended PRF, Harvesting of Free Gingival Graft and preparation of CTG and VISTA technique in people with Gingival Recession, Localized, run by Mansoura University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gingival Recession, Localized
What is being tested?
Preparation of Extended PRF, Harvesting of Free Gingival Graft and preparation of CTG and VISTA technique
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteEgypt
Study dates
1 Apr 2024to 20 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of Dentistry, Mansoura University.

    Al Mansurah

Other trials in Egypt

About this study

Official title: Extended Platelet- Rich Fibrin Membrane Combined With Vestibular Incision Subperiosteal Tunnel Access Technique as a New Treatment Modality for Localized Gingival Recession (Clinical Comparative Study)

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.

Read the detailed description

Gingival recession (GR) has been defined as the apical shift of the gingival margin in respect to the cementoenamel junction with concomitant exposure of the root surface in the oral cavity. Several etiological factors such as tissue phenotype, gingival thickness, brushing technique, non-carious and carious cervical lesions, and periodontal predisposition were identified for this condition, which may account for its relatively high incidence in the population .

When GR affects the esthetic area and is associated with dentinal hypersensitivity, exhibits a lack of an adequate band of keratinized tissue, or is concomitant with a carious or non-carious cervical lesion, treatment is often indicated. Indeed, the efficacy of surgical treatment for correction of GR defects has been extensively demonstrated with long-term stable outcomes .

With a broad variety of gingival recession cases with different clinical presentations, it is not always possible to classify all gingival recession defects according to one classification system. Several classifications have been proposed in literature to facilitate the diagnosis of gingival recessions. One of the most commonly used Cairo et al. classification (2011) which classified gingival recession based on the assessment of CAL at both buccal and interproximal sites into recession type 1, 2 and 3. This classification provides a simplified method of categorizing gingival recession and also emphasizes the role of interproximal attachment level, one of the important site-related prognostic factors .

Recession type 1 is characterized by gingival recession with no loss of interproximal attachment. Interproximal CEJ is clinically not detectable at both mesial and distal aspects of the tooth .

Several surgical techniques, such as guided tissue regeneration (GTR), subepithelial connective tissue graft procedure (SCTG), coronally advanced flap (CAF), laterally positioned flap, double papilla technique, semilunar pedicle flap, oblique rotated flap, tunnel technique (TUN), and surgical techniques based on modifications of these protocols have been proposed for the treatment of GR defects .

The subepithelial connective tissue graft (CTG) has been advanced as the "gold standard" for recession coverage around teeth . However, the limited amount of donor tissues, technique sensitivity and post-operative patient's discomfort are all considered as disadvantages for this technique .

Nowadays, patients' esthetic expectations and perception of the use of least traumatic surgeries have led to the development of minimally invasive techniques which not only obtain root coverage but also have a color match and tissue blending with adjacent tissues of the defect site .

The introduction of non-invasive techniques such as envelope and tunnel technique (TUN) had reduced the struggles in other invasive operations and provided good vascularity due to absence of the vertical releasing incision. Homa Zadeh in 2011 introduced a conservative modification in tunnel technique; vestibular incision subperiosteal tunnel access (VISTA) which preserves the papillary integrity and enhances patients' compliance .

Platelet concentration-based therapies were first used as fibrin adhesives in wound healing. Platelet-rich plasma, an autologous platelet concentration, was developed in 1998 as an enhancement factor for periodontal wound healing. Platelet-rich fibrin (PRF) is a second-generation autologous platelet concentration obtained without using any chemical substances such as anticoagulants and thrombin .

The effectiveness of autologous platelet concentration lies on the continuous release of multiple cytokines, such as transforming growth factor-β1 (TGF-β1), vascular endothelial growth factor (VEGF), insulin growth factor (IGF), platelet- derived growth factor-AB (PDGF-AB), and interleukin-1β (IL-1β) . Since the PRF preparation protocol does not require any anti-coagulants, wound healing cascade is not inhibited by anticoagulants and clot formation occurs naturally .

PRF has several advantages including high concentration of leukocytes which not only act in immune and antibacterial responses but also promote the wound-healing process. The PRF spontaneously forms a dense fibrin network that enables slower degradation rate and therefore delayed release of growth factors to the surrounding tissue during wound healing .

Platelet-rich fibrin (PRF) has been proposed as an autologous membrane with the advantages of host accumulation of platelets and leukocytes with entrapment of growth factors. However, limitations include its faster resorption properties (approximately 2 weeks). Interestingly, recent studies have demonstrated that by heating a liquid platelet-poor plasma (PPP) layer, the resorption properties of heated albumin (albumin gel) can be extended from 2 weeks to greater than 4 months (e- PRF) .

Given the encouraging effects of e-PRF in healing and regeneration of soft tissue with long-term release of growth factors, it is hypothesized that e-PRF might improve the outcomes obtained with vestibular incision subperiosteal tunnel access (VISTA) technique. To the best of the authors' knowledge, there is no controlled clinical study using VISTA combined with e-PRF for root coverage in localized Cairo type 1 recession defects.

Being tested
Preparation of Extended PRF, Harvesting of Free Gingival Graft and preparation of CTG, VISTA technique
Keywords
CTG, alb prf, extended prf, e prf, G.REC, VISTA, RT1, CAIRO
Medical subject headings
Gingival Recession

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Preparation of Extended PRFOther

    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 .

  • Harvesting of Free Gingival Graft and preparation of CTGProcedure or surgery

    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 .

  • VISTA techniqueProcedure or surgery

    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

Study groups in NCT07079293
Study groupRoleWhat they receive
Group I (control group): Connective Tissue Graft to treat patient had RT1 Gingival RecessionExperimental15 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).
Receives: 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 RecessionExperimental15 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).
Receives: Other: Preparation of Extended PRF; Procedure: VISTA technique

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Root coverage percentage (RC%)

    Root coverage percentage (%)

    Measured: 6 months

Secondary outcomes (3)
  1. Gingival thickness (GT)

    measured using an endodontic spreader with stopper (#30) 2 mm apical to the buccal gingival margin under local anesthesia

    Measured: 6 months

  2. Width of keratinized gingiva (WKG):

    (measured at the mid buccal point from the free gingival margin to the mucogingival junction).

    Measured: 6 months

  3. Sensitivity visual analogue scale (Sens VAS)

    Dental hypersensitivity tested using the air spray and quantified by patients on a visual analogue scale (VAS) from 0-10.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2025
  2. Study start1 Apr 2024
  3. Primary completion20 May 2025
  4. Study completion20 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07079293
Sponsor's protocol ID
A0801024OM
Acronym
alb prf REC
Status last verified
Jul 2025
First submitted
13 Jul 2025
Last updated
23 Jul 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Preparation of Extended PRF, Harvesting of Free Gingival Graft and preparation of CTG and VISTA technique in people with Gingival Recession, Localized, run by Mansoura University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Root coverage percentage (RC%) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.

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