- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05916742
Biofunctionalization of a Volume-stable Collagen Matrix (VCMX) for the Treatment of Single Gingival Recession
June 14, 2023 updated by: Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
75
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
São Paulo
-
São José Dos Campos, São Paulo, Brazil, 12245-000
- Recruiting
- Sao Paulo State University
-
Contact:
- Mauro Santamaria, PhD
- Phone Number: 1239479000
- Email: mauro.santamaria@unesp.br
-
Contact:
- Amanda Rossato, MS
- Email: amanda.rossato@unesp.br
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
All participants will be instructed to take 500 mg sodium dipyrone just in case of pain.
Other Names:
Periodontal surgical technique to treat gingival recessions
Other Names:
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 Names:
Porcine derived collagen matrix.
Other Names:
All participants will be instructed to perform 0.12% chlorhexidine rinse after the surgical procedures.
Other Names:
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 Names:
|
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.
|
All participants will be instructed to take 500 mg sodium dipyrone just in case of pain.
Other Names:
Periodontal surgical technique to treat gingival recessions
Other Names:
Porcine derived collagen matrix.
Other Names:
All participants will be instructed to perform 0.12% chlorhexidine rinse after the surgical procedures.
Other Names:
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 Names:
|
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.
|
All participants will be instructed to take 500 mg sodium dipyrone just in case of pain.
Other Names:
Periodontal surgical technique to treat gingival recessions
Other Names:
All participants will be instructed to perform 0.12% chlorhexidine rinse after the surgical procedures.
Other Names:
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dentine hypersensitivity
Time Frame: 6 months
|
Evaluation of root sensitivity with the air blow test and measurement with a visual analog scale (VAS).
|
6 months
|
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).
|
14 days
|
Patient-centred esthetic evaluation
Time Frame: 6 months
|
Esthetic evaluation performed by the patient through a visual analog scale (VAS).
|
6 months
|
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.
|
6 months
|
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.
|
Baseline, 3, 7, 14, 30, and 60 days after surgery
|
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.
|
Baseline, 45 days, and 6 months after the procedure.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 15, 2022
Primary Completion (Estimated)
December 1, 2023
Study Completion (Estimated)
December 18, 2023
Study Registration Dates
First Submitted
June 14, 2023
First Submitted That Met QC Criteria
June 14, 2023
First Posted (Actual)
June 23, 2023
Study Record Updates
Last Update Posted (Actual)
June 23, 2023
Last Update Submitted That Met QC Criteria
June 14, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Stomatognathic Diseases
- Periodontal Diseases
- Mouth Diseases
- Gingival Diseases
- Periodontal Atrophy
- Gingival Recession
- Physiological Effects of Drugs
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antipyretics
- Anti-Bacterial Agents
- Disinfectants
- Chlorhexidine
- Amoxicillin
- Dipyrone
Other Study ID Numbers
- VCMX+iPRF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gingival Recession
-
British University In EgyptNot yet recruiting
-
SVS Institute of Dental SciencesCompleted
-
University of LouisvilleCompletedRecession, GingivalUnited States
-
Cairo UniversityUnknownRecession, Gingival
-
Botiss Medical AGCompletedRecession, GingivalSerbia
-
Centre Hospitalier Universitaire de LiegeRecruitingGingival Recession | Gingival Recession, LocalizedBelgium
-
University of Turin, ItalyRecruitingGingival Recession, GeneralizedItaly
-
Berceste GulerEnrolling by invitationGingival Recession | Gingival Recession, LocalizedTurkey
-
Ain Shams UniversityCompletedLocalized Gingival RecessionEgypt
-
Misr International UniversityAin Shams UniversityCompletedGingival Recession, LocalizedEgypt
Clinical Trials on Sodium dipyrone
-
University Center of AraraquaraUniversity of Sao PauloCompletedPain, Postoperative
-
University Hospital, Basel, SwitzerlandCompleted
-
Universidade Estadual Paulista Júlio de Mesquita...CompletedGingival Recession | Tooth Abrasion
-
Ache Laboratorios Farmaceuticos S.A.Withdrawn
-
EMSNot yet recruiting
-
EMSWithdrawn
-
Universidade Estadual Paulista Júlio de Mesquita...RecruitingGingival Recession, Localized | Tooth AbrasionBrazil
-
Universidade Estadual Paulista Júlio de Mesquita...CompletedGingival Recession
-
Universidade Estadual Paulista Júlio de Mesquita...Fundação de Amparo à Pesquisa do Estado de São PauloUnknownGingival Recession | Tooth AbrasionBrazil