Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06650072
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Effectiveness of Tuberosity Micro Connective Tissue Graft for Treatment of Multiple Adjacent Gingival Recession Defects
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Palatal vs Tuberosity Micro-connective Tissue Grafts for the Treatment of Multiple Adjacent Gingival Recession Defects a Multi-center Controlled Randomized 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:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this project is to compare post-operative pain associated with palatal and tuberosity donor sites for micro-CTG and to evaluate the outcomes in both the donor and recipient sites
Detailed Description:
A variety of surgical methods have been reported to reestablish root coverage including tunneling techniques and coronally and laterally advanced flaps As thin gingival tissue is one of the predisposing factors for GRD the adjuvant use of subepithelial connective tissue grafts CTGs 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 CTGs are preferably harvested either from the lateral superficial part of the palate or from the tuberosity due to the high amount of lamina propria and minimal submucosal tissue adipose and glandular tissue
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 Modification of the harvested CTG into multiple micro-CTG has been proposed for the treatment of multiple adjacent GRDs MAGRD in order to reduce the amount of CTG to be harvested Soft-tissue grafts from the tuberosity are increasingly gaining popularity not only because they are easier to harvest are denser in connective tissue fibers but also because harvesting from the tuberosity presents minimal risk of intra- or post-operative complications resulting in reduced patient morbidity However CTG from maxillary tuberosity have been reported to induce a hyperplastic response in some patients
The objective of this study will be to compare palatal versus tuberosity micro-CTG on postoperative pain oral health-related quality of life OHRQoL degree of root coverage and esthetic outcomes
The investigators hypothesise that no statistically significant differences will be observed in terms of root coverage and patient satisfaction at 12 months non-inferiority Subjects in the test group micro-CTG will report significantly lower morbidity at 1 and 2 weeks post-surgery when compared to controls superiority
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 Modification of the harvested CTG into multiple micro-CTG has been proposed for the treatment of multiple adjacent GRDs MAGRD in order to reduce the amount of CTG to be harvested Soft-tissue grafts from the tuberosity are increasingly gaining popularity not only because they are easier to harvest are denser in connective tissue fibers but also because harvesting from the tuberosity presents minimal risk of intra- or post-operative complications resulting in reduced patient morbidity However CTG from maxillary tuberosity have been reported to induce a hyperplastic response in some patients
The objective of this study will be to compare palatal versus tuberosity micro-CTG on postoperative pain oral health-related quality of life OHRQoL degree of root coverage and esthetic outcomes
The investigators hypothesise that no statistically significant differences will be observed in terms of root coverage and patient satisfaction at 12 months non-inferiority 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?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None