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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Gingival Recession, Localized; Tooth Abrasion
• Intervention / Treatment: Procedure: Restorative procedure; Procedure: Coronally Advanced Flap (CAF).; Drug: Sodium dipyrone; Device: Volume-stable collagen matrix (VCMX); Drug: Amoxicillin 500mg

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mauro P Santamaria, PhD; Phone Number: +55 (12) 39479055; Email: mauro.santamaria@unesp.br

Study Locations

• Brazil
  • SP
    • São José Dos Campos, SP, Brazil, 1224500
      • Recruiting
      • São Paulo State University
      • Contact: Mauro P Santamaria, PhD; Phone Number: +55 39479373; Email: mauro.santamaria@unesp.br
      • Contact: Manuela Maria V Miguel, MS; Phone Number: +55 (12) 39479055; Email: manuela.miguel@unesp.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.; Drug: Sodium dipyrone; All participants will be instructed to take 500 mg sodium dipyrone just in case of pain.; Other Names: Post operative care
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.	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.; Drug: Sodium dipyrone; All participants will be instructed to take 500 mg sodium dipyrone just in case of pain.; Other Names: Post operative care; 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 Names: Post operative care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recession reduction (RecRed)	Difference between the final depth of gingival recession in millimeters and gingival margin initial position in millimeters measured through a periodontal probe.	180 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral Health Impact Profile	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)	14 days
Number of analgesics	Number of analgesics used during 14 days after the procedure will be reported at the same postoperative diary (Tonetti et al. 2017).	14 days
Patient Discomfort	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).	14 days
Dentine hypersensitivity	Root sensitivity assessemnt with the air blow test and measurement with a visual analog scale (VAS).	180 days
Patient-centered esthetic evaluation	Using a visual analog scale (VAS), patients will be able to report their opinion regarding esthetic	180 days
Percentage of Complete Combined Defect Coverage (%CDC)	This assement is calculated as follow: (RecRed x 100)/CD	180 days
Modification of the Root Coverage Esthetic Score (MRES)	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).	180 days
Clinical Parameters	Probing Depth (PD); Relative Gingival Recession (RGR); Relative Clinical Attachment level (RCAL); Keratinized tissue width (KTW); Keratinized tissue thickness (KTT).	180 days

Collaborators and Investigators

• Sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho

Publications and helpful links

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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: June 14, 2023
• First Submitted That Met QC Criteria: June 22, 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 22, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Gingival Recession; Biomaterials; Tooth Abrasion
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Tooth Diseases; Periodontal Atrophy; Tooth Wear; Gingival Recession; Tooth Abrasion; Physiological Effects of Drugs; 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; Amoxicillin; Dipyrone
• Other Study ID Numbers: UEPJMF 13

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