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

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ClinicalTrials.gov Identifier: NCT05916742
Recruitment Status : Recruiting
First Posted : June 23, 2023
Last Update Posted : June 23, 2023
Sponsor:
Information provided by (Responsible Party):
Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Gingival Recession Procedure: CAF Procedure: i-PRF Device: VCMX Drug: Sodium dipyrone Drug: Chlorhexidine rinse Drug: Amoxicillin 500mg Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Functionalization of a Volume-stable Collagen Matrix (VCMX) Using Injectable Platelet Rich Fibrin (i-PRF) for the Treatment of Single Gingival Recession
Actual Study Start Date : April 15, 2022
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : December 18, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arms and Interventions
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Arm Intervention/treatment
Experimental: CAF+VCMX+i-PRF
The 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.
 Procedure: CAF
Periodontal surgical technique to treat gingival recessions
Other Name: Periodontal plastic surgery

Procedure: i-PRF
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).
Other Name: injectable platelet rich-fibrin

Device: VCMX
Porcine derived collagen matrix.
Other Names:
  • Volume-stable collagen matrix
  • Geistlich Fibro-Gide

Drug: Sodium dipyrone
All participants will be instructed to take 500 mg sodium dipyrone just in case of pain.
Other Name: Drug prescription

Drug: Chlorhexidine rinse
All participants will be instructed to perform 0.12% chlorhexidine rinse after the surgical procedures.
Other Name: Drug prescription

Drug: Amoxicillin 500mg
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.
Other Name: Drug prescription
Experimental: CAF+VCMX
The 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.
 Procedure: CAF
Periodontal surgical technique to treat gingival recessions
Other Name: Periodontal plastic surgery

Device: VCMX
Porcine derived collagen matrix.
Other Names:
  • Volume-stable collagen matrix
  • Geistlich Fibro-Gide

Drug: Sodium dipyrone
All participants will be instructed to take 500 mg sodium dipyrone just in case of pain.
Other Name: Drug prescription

Drug: Chlorhexidine rinse
All participants will be instructed to perform 0.12% chlorhexidine rinse after the surgical procedures.
Other Name: Drug prescription

Drug: Amoxicillin 500mg
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.
Other Name: Drug prescription
Active Comparator: CAF
The 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.
 Procedure: CAF
Periodontal surgical technique to treat gingival recessions
Other Name: Periodontal plastic surgery

Drug: Sodium dipyrone
All participants will be instructed to take 500 mg sodium dipyrone just in case of pain.
Other Name: Drug prescription

Drug: Chlorhexidine rinse
All participants will be instructed to perform 0.12% chlorhexidine rinse after the surgical procedures.
Other Name: Drug prescription

Drug: Amoxicillin 500mg
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.
Other Name: Drug prescription


Outcome Measures
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Primary Outcome Measures :
  1. Gingival recession reduction (RecRed) [ Time Frame: 6 months ]
    Final depth of gingival recession in millimeters minus gingival margin initial position in millimeters measured through a periodontal probe.


Secondary Outcome Measures :
  1. Root coverage esthetic score [ Time Frame: 6 months ]
    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.

  2. Dentine hypersensitivity [ Time Frame: 6 months ]
    Evaluation of root sensitivity with the air blow test and measurement with a visual analog scale (VAS).

  3. Patient recovery [ Time Frame: 14 days ]
    Evaluation of postsurgery sequelae, pain, and discomfort, oral function and interference with daily activities through postoperative diary previously described (Tonetti et al. 2018).

  4. Patient-centred esthetic evaluation [ Time Frame: 6 months ]
    Esthetic evaluation performed by the patient through a visual analog scale (VAS).

  5. Immunological evaluation [ Time Frame: Baseline, 3, 7, 14, 30, and 60 days after surgery ]
    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.

  6. Microbiological evaluation [ Time Frame: Baseline, 45 days, and 6 months after the procedure. ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Smoking.
  • Contraindication for periodontal surgery.
  • Pregnancy.
  • Presence of orthodontic braces.
  • Medications known to interfere with periodontal healing.
  • Use of anticoagulants.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05916742


Locations
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Brazil
São Paulo State University Recruiting
São José Dos Campos, São Paulo, Brazil, 12245-000
Contact: Mauro Santamaria, PhD    1239479000    mauro.santamaria@unesp.br   
Contact: Amanda Rossato, MS       amanda.rossato@unesp.br   
Sponsors and Collaborators
Universidade Estadual Paulista Júlio de Mesquita Filho
More Information
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Publications:

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Responsible Party: Mauro Pedrine Santamaria, Associate professor, Universidade Estadual Paulista Júlio de Mesquita Filho
ClinicalTrials.gov Identifier: NCT05916742    
Other Study ID Numbers: VCMX+iPRF
First Posted: June 23, 2023    Key Record Dates
Last Update Posted: June 23, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho:
Platelet-rich fibrin
Gingival Recession
Additional relevant MeSH terms:
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Gingival Recession
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy
Dipyrone
Amoxicillin
Chlorhexidine
Anti-Bacterial Agents
Anti-Infective Agents
 Anti-Infective Agents, Local
Disinfectants
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antipyretics