Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-02-23 @ 11:15 AM
Study NCT ID:
NCT02613702
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-25
First Post:
2015-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of a Modified Technique of Free Gingival Graft in Volumetric Changes of the Graft: Randomized Clinical Trial
Sponsor:
University of Sao Paulo
Organization:
Study Overview
Official Title:
Efficacy of a Modified Technique of Free Gingival Graft in Volumetric Changes of the Graft: Randomized Clinical Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-05
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:
EFFECT
Brief Summary:
This study will compare a new technique of free gingival graft to the original one, in order to evaluate the stability of the graft volume over one year and other variables. Twenty patients will receive the original technique of free gingival graft (controls) and twenty patients will receive the modified technique, in which the free gingival graft is submerged (tests), at the inferior incisors area.
Detailed Description:
The free gingival graft surgery is held to gain some keratinized tissue in areas where it has been lost, such as in inferior incisors with gingival recessions. In these areas, tooth brushing may become harder and painful, negatively influencing in plaque control. However, this type of graft seems to contract over time. A new approach of free gingival graft, in which the graft is covered by a flap, promises to provide greater vascularization. This would promote less graft contraction and better mucosal color. Forty patients with less than 2 mm of keratinized tissue (measured from gingival margin to mucogingival junction) in at least one inferior incisor will be included. Half will receive the original technique and half will receive the modified one. Patients will be followed at 7, 14, 21, 28, 42 days, 3, 6, 12 months and 8 years after surgeries.
Study Oversight
Has Oversight DMC:
True
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?: