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
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Condition or disease | Intervention/treatment | Phase |
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Gingival Recession | Procedure: CAF Procedure: i-PRF Device: VCMX Drug: Sodium dipyrone Drug: Chlorhexidine rinse Drug: Amoxicillin 500mg | Not Applicable |
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 |
Arm | Intervention/treatment |
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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.
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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:
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:
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 |
- 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.
- 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.
- Dentine hypersensitivity [ Time Frame: 6 months ]Evaluation of root sensitivity with the air blow test and measurement with a visual analog scale (VAS).
- 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).
- Patient-centred esthetic evaluation [ Time Frame: 6 months ]Esthetic evaluation performed by the patient through a visual analog scale (VAS).
- 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.
- 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.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.
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
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 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Platelet-rich fibrin Gingival Recession |
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 |