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

NCT ID: NCT05916742

Last Updated: 2023-06-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-15
• Study Completion Date: 2023-12-18

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.

Conditions

Gingival Recession

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

CAF

Intervention Type: PROCEDURE

Periodontal surgical technique to treat gingival recessions

i-PRF

Intervention Type: PROCEDURE

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).

VCMX

Intervention Type: DEVICE

Porcine derived collagen matrix.

Sodium dipyrone

Intervention Type: DRUG

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

Chlorhexidine rinse

Intervention Type: DRUG

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

Amoxicillin 500mg

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

CAF

Intervention Type: PROCEDURE

Periodontal surgical technique to treat gingival recessions

VCMX

Intervention Type: DEVICE

Porcine derived collagen matrix.

Sodium dipyrone

Intervention Type: DRUG

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

Chlorhexidine rinse

Intervention Type: DRUG

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

Amoxicillin 500mg

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

CAF

Intervention Type: PROCEDURE

Periodontal surgical technique to treat gingival recessions

Sodium dipyrone

Intervention Type: DRUG

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

Chlorhexidine rinse

Intervention Type: DRUG

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

Amoxicillin 500mg

Intervention Type: DRUG

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.

Interventions

CAF

Periodontal surgical technique to treat gingival recessions

Intervention Type: 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).

Intervention Type: PROCEDURE

VCMX

Porcine derived collagen matrix.

Intervention Type: DEVICE

Sodium dipyrone

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

Intervention Type: DRUG

Chlorhexidine rinse

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Periodontal plastic surgery; injectable platelet rich-fibrin; Volume-stable collagen matrix; Geistlich Fibro-Gide; Drug prescription; Drug prescription; Drug prescription

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Estadual Paulista Júlio de Mesquita Filho

OTHER

Sponsor Role: lead

Responsible Party

Mauro Pedrine Santamaria

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

São Paulo State University

São José dos Campos, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Facility Contacts

Mauro Santamaria, PhD

Role: primary

mauro.santamaria@unesp.br

1239479000

Amanda Rossato, MS

Role: backup

amanda.rossato@unesp.br

References

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.

Reference Type: BACKGROUND

PMID: 29087001 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19335093 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17309597 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28283682 (View on PubMed)

Other Identifiers

VCMX+iPRF

Identifier Type: -

Identifier Source: org_study_id