Ignite Creation Date:
2024-05-06 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05916716
Status:
RECRUITING
Last Update Posted:
2023-06-23
First Post:
2023-06-14
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
Sponsor:
Universidade Estadual Paulista Júlio de Mesquita Filho
Organization:
Universidade Estadual Paulista Júlio de Mesquita Filho
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n25 partial restoration of cervical lesion and coronally advanced flap for root coverage PRCAF and test group n25 partial restoration of cervical lesion and coronally advanced flap associated with volume stable collagen matrix PRCAFVCMX 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None