Gingival Recession, Localized Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 1, 2023 |
Est. primary completion date | December 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Sao Paulo State University | São José Dos Campos | SP |
Lead Sponsor | Collaborator |
---|---|
Universidade Estadual Paulista Júlio de Mesquita Filho |
Brazil,
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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 coll — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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 Inves — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Dentine hypersensitivity | Root sensitivity assessemnt with the air blow test and measurement with a visual analog scale (VAS). | 180 days | |
Secondary | Patient-centered esthetic evaluation | Using a visual analog scale (VAS), patients will be able to report their opinion regarding esthetic | 180 days | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Percentage of Complete Combined Defect Coverage (%CDC) | This assement is calculated as follow: (RecRed x 100)/CD | 180 days | |
Secondary | 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 | |
Secondary | Clinical Parameters | Probing Depth (PD); Relative Gingival Recession (RGR); Relative Clinical Attachment level (RCAL); Keratinized tissue width (KTW); Keratinized tissue thickness (KTT). | 180 days |
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