Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06438094
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-26
Brief Title:
The Influence of Non-Carious Cervical Lesions on Root Coverage
Sponsor:
Gonzalo Blasi
Organization:
Universitat Internacional de Catalunya
Study Overview
Official Title:
The Influence of Non-Carious Cervical Lesions on Root Coverage by Means of Coronally Advanced Flap and a Connective Tissue Graft A Prospective Cohort Study
Status:
RECRUITING
Status Verified Date:
2024-06
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:
The goal of this prospective cohort study is to evaluate the effect of non-carious cervical lesions NCCLs on the outcome of root coverage therapy The main question it aims to answer is In gingival recessions associated with NCCLs characterized by an undetectable cemento-enamel junction CEJ reconstruction of the CEJ with a cervical composite restoration prior to root coverage surgery by means of a coronally advanced flap combined with a connective tissue graft CAFCTG provides similar clinical and patient-reported outcomes as compared to the treatment of gingival recessions associated with NCCLs characterized by a visible CEJ with root coverage surgery only by means of a CAFCTG
In NCCLs where the CEJ is undetectable B-type defect the CEJ will be reconstructed before surgery with a cervical composite restoration mimicking the anatomic features of the contralateral homologous tooth CAFCTG treatment will be performed in all cases Participants will be assessed at 6 weeks 3 months and 6 months to evaluate clinical volumetric and patient-centred outcomes
In NCCLs where the CEJ is undetectable B-type defect the CEJ will be reconstructed before surgery with a cervical composite restoration mimicking the anatomic features of the contralateral homologous tooth CAFCTG treatment will be performed in all cases Participants will be assessed at 6 weeks 3 months and 6 months to evaluate clinical volumetric and patient-centred outcomes
Detailed Description:
In this investigation a prospective cohort study several key outcomes will be assessed First we seek to determine whether restoring the cementoenamel junction CEJ in Class B GRs before root coverage therapy yields comparable clinical and volumetric outcomes to Class A GRs with detectable CEJ In addition the influence of the CEJ restoration on dentin sensitivity and aesthetic satisfaction of the patient will be investigated To our knowledge it will be the first clinical study to use Pini Prato et als surface discrepancy classification as a decision-making tool to guide periodontal-restorative procedures
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