Use of a Novel Volume-stable Collagen Matrix (VCMX) in the Treatment of Single Gingival Recession Associated With Non-carious Cervical Lesion Partially Restored

• ClinicalTrials.gov Identifier: NCT05916716
• Recruitment Status: Recruiting
• First Posted: June 23, 2023
• Last Update Posted: June 23, 2023
• Sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
• Information provided by (Responsible Party): Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho

Tracking Information

• First Submitted Date: June 14, 2023
• First Posted Date: June 23, 2023
• Last Update Posted Date: June 23, 2023
• Actual Study Start Date: August 1, 2022
• Estimated Primary Completion Date: December 1, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 22, 2023)

Recession reduction (RecRed) [ Time Frame: 180 days ]

Difference between the final depth of gingival recession in millimeters and gingival margin initial position in millimeters measured through a periodontal probe.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: June 22, 2023)

• Dentine hypersensitivity [ Time Frame: 180 days ]
  Root sensitivity assessemnt with the air blow test and measurement with a visual analog scale (VAS).
• Patient-centered esthetic evaluation [ Time Frame: 180 days ]
  Using a visual analog scale (VAS), patients will be able to report their opinion regarding esthetic
• Oral Health Impact Profile [ Time Frame: 14 days ]
  Will be evaluated from a questionnaire with 14 questions based on 7 domains: functional limitations, physical pain, psychological discomfort, physical disability, psychological deficiency and social deficiency. The patient should respond to the questions within 14 days after the surgical procedure, performing a postoperative diary. For each question an answer must be given, represented in numbers, being: 0- Never; 1- Almost never; 2-Occasionally; 3-Quite frequent; 4-Very common; 5-I do not know (Tonetti MS et al. 2017)
• Patient Discomfort [ Time Frame: 14 days ]
  By a visual analogic scale (VAS) of 100 mm to assess discomfort, patients will report pain diary during the 14 days after surgery. Scale extremes will be "no pain" to "extreme." (Tonetti et al. 2017).
• Number of analgesics [ Time Frame: 14 days ]
  Number of analgesics used during 14 days after the procedure will be reported at the same postoperative diary (Tonetti et al. 2017).
• Percentage of Complete Combined Defect Coverage (%CDC) [ Time Frame: 180 days ]
  This assement is calculated as follow: (RecRed x 100)/CD
• Modification of the Root Coverage Esthetic Score (MRES) [ Time Frame: 180 days ]
  Professional aesthetic score which evaluates six variables. The variables are :(1) the marginal tissue contour (MTC); (2) Soft tissue texture (STT); (3) mucogingival junction alignment (MGJ); (4) Gingival color (GC) and (5) Restoration/cervical lesion color (R/CLC).
• Clinical Parameters [ Time Frame: 180 days ]
  Probing Depth (PD); Relative Gingival Recession (RGR); Relative Clinical Attachment level (RCAL); Keratinized tissue width (KTW); Keratinized tissue thickness (KTT).

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Use of a Novel Volume-stable Collagen Matrix (VCMX) in the Treatment of Single Gingival Recession Associated With Non-carious Cervical Lesion Partially Restored
• Official Title: Use of a Novel Volume-stable Collagen Matrix (VCMX) in the Treatment of Single Gingival Recession Associated With Non-carious Cervical Lesion Partially Restored. A Randomized Clinical Trial
• Brief Summary: Gingival recessions (GR) are often associated with non-carious cervical lesions (NCCL), resulting, thus, in a combined defect. This mucogingival condition has a different treatment prognosis when compared with a GR without wearing surface associated and frequently requires a surgical-restorative approach to achieve better esthetics and functional results. A limited number of clinical studies assessed different multidisciplinary protocols for the management of single combined defects and there is evidence that the use of dental materials does not harm the periodontal tissues and does not influence the root coverage obtained by means of subepithelial connective tissue graft (CTG). Although the association between coronally advanced flap (CAF) and CTG provides more predictable and stable outcomes in the long term, its use is related to some drawbacks. Different biomaterials have been developed to overcome these limitations as a possible alternative to autogenous graft. However, despite its potential, there is a lack of studies evaluating its use in treating this type of condition. Thus, this study aims to assess from a clinical and esthetics point of view and patient-centered outcomes, the use of a new collagen matrix (Geistlich Fibro-Gide®) associated with CAF for the management of single combined defects. For such purpose, 50 patients with single RT1 gingival recessions associated with NCCL will be enrolled and randomly allocated to one of the following groups: control group (n=25), partial restoration of cervical lesion and coronally advanced flap for root coverage (PR+CAF) and test group (n=25), partial restoration of cervical lesion and coronally advanced flap associated with volume stable collagen matrix (PR+CAF+VCMX). The two groups will be compared regarding the clinical parameters, among which bleeding on probing (BOP), biofilm accumulation (IP), clinical attachment level (CAL), recession reduction (RecRed), and the percentage of combined defect coverage (%CDC). Patient-reported outcomes such as post-surgery pain and discomfort, time to recover, the decrease of dentin hypersensitive, and aesthetics will be gathered. A professional assessment will be carried out regarding the aesthetic parameters. All these evaluations will be performed at the baseline and three and six months postoperatively.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Gingival Recession, Localized
• Tooth Abrasion

Intervention

• Procedure: Restorative procedure
  Under local anesthesia, a rubber dam isolation will be placed at the site and a coronal bevel will be performed at the incisal margin of the NCCL allowing a correct tooth emergence profile. In sequence, acid etching with 35% phosphoric acid will be applied to the area and washed for 30 seconds with a water-air jet. The lesion will be dried with sterile cotton pellets to prevent dehydration. Active application of the adhesive will be performed for 20 seconds, followed by light curing for 30 seconds. The apical margin of the restoration will be placed 1 mm beyond the estimated position of the cementoenamel junction(CEJ) in order to rebuild only the anatomical part of the crown destroyed by the NCCL and 1 mm of the root surface to give the appropriate emergence profile. After rubber dam removal, the restoration will be finished with ultrafine-grained burs, and 48 hours after the restoration procedure, polishing will be completed with diamond paste and felt discs.
• Procedure: Coronally Advanced Flap (CAF).
  Two horizontal incisions will be performed at the papilla base united by an intrasulcular incision around the tooth. In sequence, releasing incisions will be designed and a split-full-split 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.
• Device: Volume-stable collagen matrix (VCMX)
  VCMX will be cut according to the recession defect and moistened with saline solution. The biomaterial will be placed at the cementoenamel junction (CEJ) level and stabilized in the adjacent surgical papillae by interrupted sutures.
• Drug: Amoxicillin 500mg
  Participants enrolled in the PR +CAF+VCMX will be instructed to take amoxicillin 500mg (8 hours/8 hours, during 7 days) after the surgical procedures.
  Other Name: Post operative care
• Drug: Sodium dipyrone
  All participants will be instructed to take 500 mg sodium dipyrone just in case of pain.
  Other Name: Post operative care

Study Arms

• Active Comparator: PR+CAF
  Partial restoration will be performed, and its apical margin will be placed 1 mm beyond the estimated position of the cementoenamel junction. Patients enrolled in this group will receive a coronally advanced flap (CAF). Two horizontal incisions will be performed at the papilla base united by an intrasulcular incision around the tooth. In sequence, releasing incisions will be designed and a split-full-split flap will be raised beyond the mucogingival junction. Sling sutures will be placed to stabilize the flap margin 2 mm coronal to CEJ, followed by interrupted sutures to close the releasing incisions.
  Interventions:

  • Procedure: Restorative procedure
  • Procedure: Coronally Advanced Flap (CAF).
  • Drug: Sodium dipyrone
• Experimental: PR + CAF + VCMX
  Partial restoration will be performed, and its apical margin will be placed 1 mm beyond the estimated position of the cementoenamel junction. Patients enrolled in this group will receive a coronally advanced flap (CAF) associated with a volume-stable collagen matrix (VCMX). Two horizontal incisions will be performed at the papilla base united by an intrasulcular incision around the tooth. In sequence, releasing incisions will be designed and a split-full-split flap will be raised beyond the mucogingival junction. In sequence, VCMX will be cut according to the recession defect and moistened with saline solution. The biomaterial will be placed at the cementoenamel junction level and stabilized in the adjacent surgery papillae 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.
  Interventions:

  • Procedure: Restorative procedure
  • Procedure: Coronally Advanced Flap (CAF).
  • Device: Volume-stable collagen matrix (VCMX)
  • Drug: Amoxicillin 500mg
  • Drug: Sodium dipyrone

Publications *

• Santamaria MP, Miguel MMV, Rossato A, Bonafe ACF, Ferraz LFF, Dos Santos LM, Mathias-Santamaria IF. New Volume-Stable Collagen Matrix and Modified Coronally Advanced Flap to Treat Multiple Gingival Recessions Associated With Partially Restored Non-Carious Cervical Lesions: A Case Report. Clin Adv Periodontics. 2022 Jun;12(2):69-74. doi: 10.1002/cap.10142. Epub 2020 Dec 16.
• Santamaria MP, Mathias-Santamaria IF, Ferraz LFF, Casarin RCV, Romito GA, Sallum EA, Pini-Prato GP, Casati MZ. Rethinking the decision-making process to treat gingival recession associated with non-carious cervical lesions. Braz Oral Res. 2021 Sep 24;35(Supp 2):e096. doi: 10.1590/1807-3107bor-2021.vol35.0096. eCollection 2021.
• Santamaria MP, Fernandes-Dias SB, Araujo CF, Lucas da Silva Neves F, Mathias IF, Rebelato Bechara Andere NM, Neves Jardini MA. 2-Year Assessment of Tissue Biostimulation With Low-Level Laser on the Outcomes of Connective Tissue Graft in the Treatment of Single Gingival Recession: A Randomized Clinical Trial. J Periodontol. 2017 Apr;88(4):320-328. doi: 10.1902/jop.2016.160391. Epub 2016 Nov 11.
• 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.
• Mathias-Santamaria IF, Silveira CA, Rossato A, Sampaio de Melo MA, Bresciani E, Santamaria MP. Single gingival recession associated with non-carious cervical lesion treated by partial restoration and coronally advanced flap with or without xenogenous collagen matrix: A randomized clinical trial evaluating the coverage procedures and restorative protocol. J Periodontol. 2022 Apr;93(4):504-514. doi: 10.1002/JPER.21-0358. Epub 2021 Aug 21.
• Stefanini M, Mounssif I, Barootchi S, Tavelli L, Wang HL, Zucchelli G. An exploratory clinical study evaluating safety and performance of a volume-stable collagen matrix with coronally advanced flap for single gingival recession treatment. Clin Oral Investig. 2020 Sep;24(9):3181-3191. doi: 10.1007/s00784-019-03192-5. Epub 2020 May 2.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 22, 2023): 50
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 1, 2023
• Estimated Primary Completion Date: December 1, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• adult > 20 years old;
• systemically healthy
• no signs of active periodontal disease;
• full-mouth plaque and bleeding score ≤20%;
• Gingival recession type RT1 associated with NCCL B+ on a vital canine or premolar;

Exclusion Criteria:

• Patients who had had periodontal surgery on the study area;
• Smokers patients;
• Pregnant or lactating patients;
• Ongoing orthodontic treatment;
• Patients taking medications known to interfere with the wound healing process or that contraindicate the surgical procedure

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Mauro P Santamaria, PhD; (12) 39479055 ext +55; mauro.santamaria@unesp.br

• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT05916716
• Other Study ID Numbers: UEPJMF 13
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho
• Original Responsible Party: Same as current
• Current Study Sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Universidade Estadual Paulista Júlio de Mesquita Filho
• Verification Date: June 2023