Ignite Creation Date:
2024-05-06 @ 7:31 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06030947
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-28
First Post:
2023-09-03
Brief Title:
Effectiveness of Micro Connective Tissue Graft for Treatment of Multiple Adjacent Gingival Recession Defects
Sponsor:
Göteborg University
Organization:
Göteborg University
Study Overview
Official Title:
Tunnel Surgery Combined With a Micro Connective Tissue Graft for the Treatment of Multiple Adjacent Gingival Recession Defects a Multi-center Randomized Controlled Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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 objective of this project is to evaluate 1-year outcomes of treatment of MAGRD using a modified coronally advanced tunnel technique MCAT with either conventional CTG control group or micro-CTG test group
Detailed Description:
Gingival recession defects GRD present as a partial exposure of the root surface resulting from gingival margin displacement apical to the cemento-enamel junction CEJ A variety of surgical methods have been reported to reestablish root coverage including tunneling techniques and coronally and laterally advanced flaps As the presence of thin gingival tissues is one of the predisposing factors for GRD the adjuvant use of subepithelial connective tissue grafts CTGs during the surgical correction is often considered CTGs are thought to contribute to phenotype modification and stability of treatment outcomes and studies have indicated favorable esthetic results and high degrees of root coverage documented range 69 to 97 The procedure does however require a suitable donor site When multiple adjacent teeth exhibit GRDs the preferred surgical approach should offer the greatest possible root coverage while limiting drawbacks ie patient morbidity esthetic problems Thus one of the challenges related to coverage of multiple GRDs is the scarcity of donor tissue In cases when large CTGs are required additional surgical procedures may even be necessary As an alternative a modification of the harvested CTG into multiple micro-CTGs is proposed for the treatment of multiple adjacent GRDs MAGRD In the present study the effectiveness and predictability of micro-CTGs will be evaluated in direct comparison to conventional CTGs
The investigators hypothesise that no statistically significant differences will be observed in terms of root coverage primary outcome and patient satisfaction at 12 months non-inferiority
The investigators hypothesise that subjects in the test group micro-CTG will report significantly lower morbidity at 1 and 2 weeks post-surgery when compared to controls superiority
The investigators hypothesise that no statistically significant differences will be observed in terms of root coverage primary outcome and patient satisfaction at 12 months non-inferiority
The investigators hypothesise that subjects in the test group micro-CTG will report significantly lower morbidity at 1 and 2 weeks post-surgery when compared to controls superiority
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