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Gingival RecessionNCT07736833

Efficacy of Liquid Phase Concentrated Growth Factors as an Adjunct to EDTA in the Treatment of Recession Type 1 Defect With Free Gingival Graft

A study testing Free gingival graft (FGG) with EDTA and LPCGF root surface application and Free gingival graft (FGG) with EDTA root surface biomodification in people with Gingival Recession, run by Tanta 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

The present study was designed to investigate the clinical efficacy of liquid-phase concentrated growth factors (LPCGF) as an adjunct to ethylenediaminetetraacetic acid (EDTA) for root surface biomodification prior to free gingival grafting for the management of Cairo type 1 gingival recession defects. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Gingival Recession
What is being tested?
Free gingival graft (FGG) with EDTA and LPCGF root surface application and Free gingival graft (FGG) with EDTA root surface biomodification
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteEgypt
Study dates
21 Feb 2024to 20 May 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 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Adults aged 18 to 50 years old.
  • Patients with good systemic health with no contraindication for periodontal surgery.
  • No history of systemic or local medications within the previous six months that could affect periodontal tissue health or wound healing.
  • Recession depth ≥ 3 mm, measured from the cementoenamel junction (CEJ) to the gingival margin and/ or width of attached gingiva < 3 mm.
  • Presence of identifiable cementoenamel junction (CEJ).
  • Absence of interproximal attachment loss (i.e., intact interdental bone and soft tissue, confirmed radiographically).
  • Ability to maintain adequate oral hygiene, as demonstrated during recall visits.

Who cannot join

  • Restoration or caries in the site to be treated or non-vital tooth.
  • Previous mucogingival surgery at the defect.
  • Active infectious diseases (hepatitis, HIV, etc.).
  • Smokers and pregnant patients.
  • Teeth that are tilted rotated or have any non-alterable occlusal abnormalities.
  • Sites with tooth mobility.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • faculty of dentistry, Tanta university

    Tanta, Gharbia Governorate, 31773

Other trials in Egypt

About this study

The present study was designed to investigate the clinical efficacy of liquid-phase concentrated growth factors (LPCGF) as an adjunct to ethylenediaminetetraacetic acid (EDTA) for root surface biomodification prior to free gingival grafting for the management of Cairo type 1 gingival recession defects.

Read the detailed description

Gingival recession is defined by the American Academy of Periodontology, as the exposure of the root surface caused by an apical displacement of the gingival margin relative to the cementoenamel junction. While it seldom leads to tooth loss, gingival recession can contribute to several clinical issues, including root caries, cervical abrasion, dentinal hypersensitivity, and aesthetic concerns .

The etiology of gingival recession is not yet fully understood. Nevertheless, a variety of predisposing factors have been identified, including mechanical trauma, plaque accumulation, periodontal phenotype, tooth malposition, high frenum attachment, and orthodontic treatment. Clinical evidence suggests that gingival recession commonly develops in the presence of multiple interacting risk factors rather than as a result of a single causative factor.

Several classification systems for gingival recessions have been proposed in the literature, with the aim of creating specific categories related to diagnosis, prognosis, and treatment plan. The main classifications were the following: Sullivan \& Atkins (1968) ; Mlinek et al (1973) ; Miller (1985) ; Smith (1997) , Mahajan (2010) ; Cairo (2011) ; Kumar (2013) , Cortellini and Bissada (2018) 3and Chambrone and Avila-Ortiz (2021) .

Even though Miller's classification is still very popular, inherent drawbacks associated with the Miller's system have started to emerge, suggesting either a modification or replacement of the Miller's classification system with some of the more recent and updated classification systems.

Cairo et al., introduced a classification system of gingival recession using the level of interdental clinical attachment as an identification criterion. This system identified three recession types namely: recession type 1 (RT1) included defects without loss of interproximal attachment while recession type 2 (RT2) showed interproximal attachment loss .In recession type 3 (RT3), the interproximal attachment loss was more than the buccal site and may be associated with an interproximal intrabony defect .

Modern periodontal plastic surgery comprises a multitude of procedures to treat and prevent periodontal recessions. According to the suggestions of Miller and Harris , surgical coverage of periodontal recessions should achieve the goal to reestablish a complete root coverage with a sufficient width of keratinized gingiva (≥2 mm), an aesthetically acceptable result and a physiologic form of the gingiva.

Pedicle soft-tissue graft procedures used in the treatment of recession defects may basically be classified into advanced flap procedures (coronally repositioned flap, semilunar coronally repositioned flap), rotational flap procedures (laterally sliding flap, double papilla flap, oblique rotated flap), regenerative procedures (with barrier membrane or with the application of enamel matrix proteins) and free soft-tissue graft procedures.

The free gingival graft (FGG) is a well-established surgical technique that can be performed as either a single-stage or two-stage procedure for root coverage. Although subepithelial connective tissue grafts have demonstrated high effectiveness in treating Miller Class I and Class II gingival recessions, FGG remains advantageous in areas with insufficient attached gingiva and shallow vestibular depth. Its strengths lie in its simplicity, ability to treat multiple teeth simultaneously, ease of tissue management, and applicability in cases with limited adjacent keratinized gingiva. Furthermore, FGG offers some degree of root coverage through creeping attachment.

Attempts have been directed toward improving the success and predictability of FGG procedures. It has been shown that pathological alterations of exposed root surfaces may interfere with the establishment of new connective tissue attachment. Consequently, considerable attention has been given to root surface conditioning techniques aimed at creating a biologically favorable environment for cell adhesion, removing the smear layer, and enhancing the biocompatibility of the treated root surface. Various agents have been suggested including citric acid, tetracycline HCI,ethylenediaminetetraacetic acid (EDTA), phosphoric acid, enamel matrix proteins , and growth factors including, platelet-rich plasma, injectable Platelet- rich fibrin (I-PRF) and liquid phase of concentrated growth factors.

EDTA is a chelating agent that combines to calcium molecules from root surfaces removing them from the tooth surface . which appears to promote early cell and tissue colonization by providing a more biocompatible surface for cell and tissue attachment. Being independent on a low pH, therefore no any toxicological side effects. This eliminates the necrotizing effect on the surrounding periodontal tissues. The recommended concentration of EDTA should be somewhere between15 to 24% in order to obtain an acceptable smear removing and collagen exposing effect.

Biologic constructs, especially growth factors, have gained significant interest for their ability to enhance the proliferation and adhesion of cultured periodontal ligament (PDL) cells on periodontally affected root surfaces. These agents show considerable promise in clinical periodontics, offering both biological efficacy and potential economic benefits.

The two most important families of growth factors can be classified as: bone-derived growth factors, namely the bone morphogenic protein (BMPs) family, and the autologous blood-derived growth factors which are released upon platelet activation. Accordingly, autologous blood-derived growth factor e.g., Platelet rich plasma (PRP), platelet rich fibrin (PRF) and concentrated growth factors (CGF) could be used in the treatment of gingival recessions to accelerate wound healing and repair.

However, the early generations of platelets concentrate have not been used as a root surface conditioner due to lack of the liquid phase. In recent years, major developments and advancements have been made with the aim of developing a liquid formulation of PRF (injectable platelet-rich fibrin, (I-PRF). Furthermore, modifications to centrifugation tubes have further allowed for a working liquid-phase concentrated growth factors (LPCGF) that may be used as a periodontal root surface conditioner.

In vitro study, was conducted to assess the effectiveness of EDTA and/or LPCGF on periodontally diseased root surfaces through their effects on PDL cells and revealed that the combination of LPCGF, which contains abundant chemotactic factors, with EDTA could induce greater recruitment of PDL cells than EDTA alone, accelerating the periodontal healing process. Moreover, they showed that, the application of LPCGF alone did not remove the smear layer, and its effect was poorer than that of combined LPCGF and EDTA application. Therefore, the combined treatment for root surface treatment/root surface biological modification is more effective due to slow sustained release of growth factors from LPCG which promote cell growth for a long period of time.

Therefore, our clinical study was conducted to determine whether LPCGF has a valuable role in improving wound healing and recession coverage after free gingiva graft surgery for the management of Cairo type 1 gingival recession defects.

Being tested
Free gingival graft (FGG) with EDTA and LPCGF root surface application, Free gingival graft (FGG) with EDTA root surface biomodification
Keywords
FGG with EDTA and LPCGF root biomodification
Medical subject headings
Gingival Recession

What participants receive

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

  • Free gingival graft (FGG) with EDTA and LPCGF root surface applicationProcedure or surgery

    Free gingival graft (FGG) with EDTA and LPCGF root surface biomodification

  • Free gingival graft (FGG) with EDTA root surface biomodificationProcedure or surgery

    Free gingival graft (FGG) with EDTA root surface biomodification

Study groups in NCT07736833
Study groupRoleWhat they receive
Group I: Free gingival graft (FGG) with EDTA root surface biomodificationActive comparatorGroup I: Free gingival graft (FGG) with EDTA root surface biomodification
Receives: Procedure: Free gingival graft (FGG) with EDTA root surface biomodification
Group II: Free gingival graft (FGG) with EDTA and LPCGF root surfaceExperimentalGroup II: Free gingival graft (FGG) with EDTA and LPCGF root surface
Receives: Procedure: Free gingival graft (FGG) with EDTA and LPCGF root surface application

What is being measured

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

  1. Width of attached gingiva (AG)

    calculated by subtracting probing pocket depth from the width of keratinized gingiva measured from the free gingival margin to the mucogingival junction, as determined by the roll technique

    Measured: Baseline, 1 month, 3 months, and 6 months

  2. Gingival thickness (GT)

    Measured: baseline, 1 month, 3 months, and 6 months

Secondary outcomes (5)
  1. Probing pocket depth (PPD)

    Measured in millimeters using a UNC-15 periodontal probe according to standard clinical criteria.

    Measured: baseline and 6 months postoperative

  2. Recession width (RW)

    measured horizontally at the level of the CEJ

    Measured: Baseline, 1 month, 3 months, and 6 months.

  3. Recession depth (RD)

    measured as the distance from the cementoenamel junction (CEJ) to the most apical point of the gingival margin

    Measured: baseline, 1 month, 3 months, and 6 months

  4. Clinical attachment level (CAL)

    Measured: base line and 6 months postoperative

  5. Percentage of root coverage (RC)

    RC=(RD_"baseline" ⓜ-RD_6" months" )/(RD_"baseline" )×100

    Measured: 6 months postoperative

Timeline

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

  1. First posted30 Jul 2026
  2. Study start21 Feb 2024
  3. Primary completion21 Feb 2025
  4. Study completion20 May 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
Model description
The 20 sites will be classified randomly by the sealed envelope technique into the two treatment groups, 10 sites in each group.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07736833
Sponsor's protocol ID
FGG with EDTA and LPCGF
Status last verified
Jul 2026
First submitted
26 Jul 2026
Last updated
30 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Free gingival graft (FGG) with EDTA and LPCGF root surface application and Free gingival graft (FGG) with EDTA root surface biomodification in people with Gingival Recession, run by Tanta 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 7 inclusion and 6 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 30 Jul 2026. 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?

Width of attached gingiva (AG) (time frame: Baseline, 1 month, 3 months, and 6 months). The study lists 2 primary outcomes in all. 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 30 Jul 2026.

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