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Gingival RecessionNCT05916742

Biofunctionalization of a Volume-stable Collagen Matrix (VCMX) for the Treatment of Single Gingival Recession

A study testing CAF, i-PRF and VCMX in people with Gingival Recession, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The treatment of single gingival recessions comprises different well-established techniques, and the association between coronally advanced flap (CAF) and the subepithelial connective tissue graft is considered the gold standard. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Gingival Recession
What is being tested?
CAF, i-PRF and VCMX
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteBrazil
Study dates
15 Apr 2022to 18 Dec 2023
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Presence of RT1 (Cairo et al., 2011) buccal single gingival recession (GR) on vital upper or lower canines and premolars with intact root surface (visible CEJ).
  • Presence of dentin hypersensitivity (HD) and/or esthetic concerns related to GR.
  • Adults > 18 years old.
  • Systemically health.
  • No signs of active periodontal disease.
  • Full-mouth plaque and bleeding score ≤ 20%.
  • Written informed consent given.

Who cannot join

  • Smoking.
  • Contraindication for periodontal surgery.
  • Pregnancy.
  • Presence of orthodontic braces.
  • Medications known to interfere with periodontal healing.
  • Use of anticoagulants.

Trial locations and contacts

1 site in 1 country.

Brazil1 site, 1 recruiting

  • São Paulo State University

    São José dos Campos, São Paulo, 12245-000

    Mauro Santamaria, PhD, 1239479000, mauro.santamaria@unesp.br

    Amanda Rossato, MS, amanda.rossato@unesp.br

    Recruiting

Other trials in Brazil

About this study

Official title: Functionalization of a Volume-stable Collagen Matrix (VCMX) Using Injectable Platelet Rich Fibrin (i-PRF) for the Treatment of Single Gingival Recession

The treatment of single gingival recessions comprises different well-established techniques, and the association between coronally advanced flap (CAF) and the subepithelial connective tissue graft is considered the gold standard. However, despite the excellent clinical results obtained, the use of subepithelial connective tissue graft is related to an increased risk of trans and postoperative bleeding, a longer duration of the surgical procedure and greater postoperative pain and morbidity. To overcome these limitations and increase patient acceptance, new biomaterials have been developed as possible alternatives to the use of connective tissue graft. Recently, tissue engineering has been investigating collagen matrices as carriers of biologically active substances. In vitro and in vivo studies have shown that the biofunctionalization of these matrices using injectable platelet rich-fibrin (i-PRF) can optimize the healing process of soft tissues using own's patient regenerative components. However, although it has promising potential, clinical studies evaluating the performance of functionalized collagen matrices are still scarce in the literature. Thus, the present study aims to evaluate the clinical, esthetic, patient-centered, immuno and microbiological results of the use of the biofunctionalized volume stable collagen matrix (VCMX) for the treatment of single gingival recessions RT1. For such purpose, a randomized controlled clinical trial of superiority, parallel and blind will be carried out. Seventy-five patients with RT1 single gingival recession will be selected, who will be randomly allocated to one of the following groups: CAF+VCMX+i-PRF (n = 25), coronally advanced flap associated with VCMX functionalized with i-PRF; CAF+VCMX (n=25), coronally advanced flap associated with VCMX; and CAF group (n = 25), coronally advanced flap alone (CAF). The groups will be compared regarding clinical, esthetic and patient-centered outcomes at the baseline, three and six months after the surgical procedure. The microbiological evaluation will be performed at baseline, three and six months after surgery and the concentration of inflammatory markers and growth factors will be assessed before the procedure and 3, 7, 14, 30 and 60 days after treatment.

Being tested
CAF, i-PRF, VCMX, Sodium dipyrone, Chlorhexidine rinse
Keywords
Platelet-rich fibrin, Gingival Recession
Medical subject headings
Gingival Recession

What participants receive

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

  • CAFProcedure or surgery

    Also called Periodontal plastic surgery

    Periodontal surgical technique to treat gingival recessions

  • i-PRFProcedure or surgery

    Also called injectable platelet rich-fibrin

    Blood-derived biomaterial. Two sterile plastic tubes (Process for PRF, Nice, France) with a volume of 10 ml will be used to generate fluid blood concentrate. After blood collection, the tubes will be centrifuged using a Duo centrifuge (Process for PRF, Nice, France) (fixed angle rotor with a radius of 110 mm) following the protocol proposed by Choukroun et al. (2018) (600 rpm; 8 min).

  • VCMXDevice

    Also called Volume-stable collagen matrix, Geistlich Fibro-Gide

    Porcine derived collagen matrix.

  • Sodium dipyroneDrug

    Also called Drug prescription

    All participants will be instructed to take 500 mg sodium dipyrone just in case of pain.

  • Chlorhexidine rinseDrug

    Also called Drug prescription

    All participants will be instructed to perform 0.12% chlorhexidine rinse after the surgical procedures.

  • Amoxicillin 500mgDrug

    Also called Drug prescription

    Participants enrolled in the CAF+VCMX and CAF+VCMX will be instructed to take amoxicillin 500mg (8 hours/8 hours, during 7 days) after the surgical procedures.

Study groups in NCT05916742
Study groupRoleWhat they receive
CAF+VCMX+i-PRFExperimentalThe surgical procedure for root coverage will be the trapezoidal-type of coronally advanced flap previously described (de Sanctis \& Zucchelli 2007). Thus, it will start with two divergent releasing incisions lateral to the gingival recession defect. These releasing incisions will then be united by a sulcular incision, and the flap will be raised beyond the mucogingival junction. Subsequently, a VCMX functionalized with injectable platelet rich-fibrin (I-PRF) will be placed at the cemento-enamel junction (CEJ) level and stabilized in the adjacent interdental connective beds by interrupted sutures. Then, sling sutures will be placed to stabilize the flap margin 2 mm coronal to CEJ, followed by interrupted sutures to close the releasing incisions.
Receives: Procedure: CAF; Procedure: i-PRF; Device: VCMX; Drug: Sodium dipyrone; Drug: Chlorhexidine rinse; Drug: Amoxicillin 500mg
CAF+VCMXExperimentalThe surgical procedure for root coverage will be the trapezoidal-type of coronally advanced flap previously described (de Sanctis \& Zucchelli 2007). Thus, it will start with two divergent releasing incisions lateral to the gingival recession defect. These releasing incisions will then be united by a sulcular incision, and the flap will be raised beyond the mucogingival junction. Subsequently, a VCMX will be placed at the cemento-enamel junction (CEJ) level and stabilized in the adjacent interdental connective beds by interrupted sutures. Then, sling sutures will be placed to stabilize the flap margin 2 mm coronal to CEJ, followed by interrupted sutures to close the releasing incisions.
Receives: Procedure: CAF; Device: VCMX; Drug: Sodium dipyrone; Drug: Chlorhexidine rinse; Drug: Amoxicillin 500mg
CAFActive comparatorThe surgical procedure for root coverage will be the trapezoidal-type of coronally advanced flap previously described (de Sanctis \& Zucchelli 2007). Thus, it will start with two divergent releasing incisions lateral to the gingival recession defect. These releasing incisions will then be united by a sulcular incision, and the flap will be raised beyond the mucogingival junction. Then, sling sutures will be placed to stabilize the flap margin 2 mm coronal to CEJ, followed by interrupted sutures to close the releasing incisions.
Receives: Procedure: CAF; Drug: Sodium dipyrone; Drug: Chlorhexidine rinse; Drug: Amoxicillin 500mg

What is being measured

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

  1. Gingival recession reduction (RecRed)

    Final depth of gingival recession in millimeters minus gingival margin initial position in millimeters measured through a periodontal probe.

    Measured: 6 months

Secondary outcomes (6)

  1. Root coverage esthetic score

    The Root Coverage Esthetic Scale (RES; Cairo et al., 2009) will be performed by two blinded and independent examiners at the 6-month post-operative assessment. This score evaluates five variables: level of the gingival margin, marginal tissue contour, soft tissue texture, mucogingival junction alignment, and gingival color.

    Measured: 6 months

  2. Dentine hypersensitivity

    Evaluation of root sensitivity with the air blow test and measurement with a visual analog scale (VAS).

    Measured: 6 months

  3. Patient recovery

    Evaluation of postsurgery sequelae, pain, and discomfort, oral function and interference with daily activities through postoperative diary previously described (Tonetti et al. 2018).

    Measured: 14 days

  4. Patient-centred esthetic evaluation

    Esthetic evaluation performed by the patient through a visual analog scale (VAS).

    Measured: 6 months

  5. Immunological evaluation

    Gingival crevicular fluid will be collected in order to evaluate the levels of nine inflammatory markers: IL1β, IL4, IL5, IL6, IL9, IL10, IL17A, Interferon gamma-induced protein 10 kDa (IP10), macrophage inflammatory protein 1α (MIP1α), monocyte chemotactic protein 1α (MCP-1α), and tumor necrosis factor α (TNFα). The following growth factors will be evaluated: EGF, TGF, PDGF, FGF, and VEGF. In addition, MMP-1, MMP-2 from TIMP-1, and TIMP-2 will also be evaluated.

    Measured: Baseline, 3, 7, 14, 30, and 60 days after surgery

  6. Microbiological evaluation

    The collection of the subgingival biofilm will be performed in order to quantificate microorganisms such as Porphyromonas gingivalis, Tannerella forsythia, Prevotella intermedia, Fusobacterium nucleatum e Streptococcus sanguinis.

    Measured: Baseline, 45 days, and 6 months after the procedure.

Timeline

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

  1. First posted23 Jun 2023
  2. Study start15 Apr 2022
  3. Primary completion1 Dec 2023 (estimated)
  4. Study completion18 Dec 2023 (estimated)

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
Parallel assignment
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05916742
Sponsor's protocol ID
VCMX+iPRF
Status last verified
Jun 2023
First submitted
14 Jun 2023
Last updated
23 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Tonetti MS, Cortellini P, Pellegrini G, Nieri M, Bonaccini D, Allegri M, Bouchard P, Cairo F, Conforti G, Fourmousis I, Graziani F, Guerrero A, Halben J, Malet J, Rasperini G, Topoll H, Wachtel H, Wallkamm B, Zabalegui I, Zuhr O. Xenogenic collagen matrix or autologous connective tissue graft as adjunct to coronally advanced flaps for coverage of multiple adjacent gingival recession: Randomized trial assessing non-inferiority in root coverage and superiority in oral health-related quality of life. J Clin Periodontol. 2018 Jan;45(1):78-88. doi: 10.1111/jcpe.12834. Epub 2017 Nov 21.

    PubMed 29087001

  • Cairo F, Rotundo R, Miller PD, Pini Prato GP. Root coverage esthetic score: a system to evaluate the esthetic outcome of the treatment of gingival recession through evaluation of clinical cases. J Periodontol. 2009 Apr;80(4):705-10. doi: 10.1902/jop.2009.080565.

    PubMed 19335093

  • de Sanctis M, Zucchelli G. Coronally advanced flap: a modified surgical approach for isolated recession-type defects: three-year results. J Clin Periodontol. 2007 Mar;34(3):262-8. doi: 10.1111/j.1600-051X.2006.01039.x.

    PubMed 17309597

  • Choukroun J, Ghanaati S. Reduction of relative centrifugation force within injectable platelet-rich-fibrin (PRF) concentrates advances patients' own inflammatory cells, platelets and growth factors: the first introduction to the low speed centrifugation concept. Eur J Trauma Emerg Surg. 2018 Feb;44(1):87-95. doi: 10.1007/s00068-017-0767-9. Epub 2017 Mar 10.

    PubMed 28283682

  • Santamaria MP, Rossato A, Miguel MMV, Bonafe ACF, Mathias-Santamaria IF, Nunes MP. Treatment of single gingival recessions using iPRF-biofunctionalized collagen matrix: A randomized clinical trial. J Periodontol. 2026 Jun 4. doi: 10.1002/jper.70152. Online ahead of print.

    PubMed 42237671

Questions about this trial

What is this clinical trial studying?

A study testing CAF, i-PRF and VCMX in people with Gingival Recession, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.

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: status not confirmed, as of the sponsor's last update on 23 Jun 2023. 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 Brazil. 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?

Results are not available in the source record.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gingival recession reduction (RecRed) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05916742, which also lists 5 linked publications.

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 Jun 2023.

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