Ignite Creation Date:
2024-05-06 @ 7:30 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06037694
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2023-09-07
Brief Title:
Effectiveness of Meshed Free Gingival Graft for Widening of Keratinized Tissues
Sponsor:
Göteborg University
Organization:
Göteborg University
Study Overview
Official Title:
Widening of Keratinized Tissues With an Expanded Meshed Free Gingival Graft a Multi-center Randomized Controlled Trial
Status:
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 overall objective of this project is to evaluate over a period of 1 year the outcomes of either conventional free gingival graft FGG or mesh-FGG to increase the width of keratinized mucosa KM at implant sites
Detailed Description:
The importance of the width of keratinized mucosa KM at implant sites remains a subject of ongoing debate Reduced dimensions of KM width 2 mm are associated with mucosal recession biofilm accumulation soft-tissue inflammation marginal bone loss peri-implantitis and patient discomfort Surgical options to increase the width of KM include an apically positioned flap either alone or in combination with an autogenous graft or a xenogeneic collagen matrix The free gingival graft FGG is a well-established technique with a history of successful clinical use The harvesting procedure for autogenous graft from the palatal mucosa however is usually associated with significant patient morbidity especially when there is a need to graft extensive mucosal areas To overcome this problem various graft modifications have been proposed to limit the need for large-area autografts Examples include the accordion technique the strip gingival autograft technique and a vertical modification of the strip gingival graft The expanded mesh graft another graft modification has been used in the field of plastic surgery especially in the treatment of large burn wounds Recently De Greef Carcuac De Mars et al proposed this technique to be used in periodontal plastic surgery more specifically in the widening of KM at implant sites by means of a meshed free gingival graft mesh-FGG In this case series initially inadequate width of KM in edentulous areas could be successfully increased prior to implant installation without the need for any extensive autograft harvesting Data from trials comparing mesh-FGG to conventional FGG and assessing the long-term efficacy of this novel technique however are missing
The investigators hypothesize that the mesh-FGG technique will demonstrate similar clinical results non-inferiority increase in KM width but improved patient-reported outcomes superiority post-surgical morbidity compared to the FGG
The investigators hypothesize that the mesh-FGG technique will demonstrate similar clinical results non-inferiority increase in KM width but improved patient-reported outcomes superiority post-surgical morbidity compared to the FGG
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