Faculdade de Odontologia da USP
São Paulo, 05508-000, Brazil
NCT Number: NCT02613702
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–65 year
All sexes
Interventional
Not applicable
São Paulo, 05508-000, Brazil
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Surgical technique (autologous graft): Free gingival graft technique, harvested from palate.
Surgical technique (autologous graft): Original technique of free gingival graft, positioned at the inferior incisors area at the donor area
Surgical technique (autologous graft): Free gingival graft. positioned at the inferior incisors area and covered by a flap at the donor area
Time frame: 12 months
Distance between gingival margin and mucogingival junction, in millimeters
Time frame: 12 months
Distance between gingival margin and bottom of the sulcus / pocket, in millimeters
Time frame: 12 months
Keratinized tissue area, measured in millimeters
Time frame: 12 months
Keratinized tissue thickness measured in millimeters
Time frame: 12 months
Volume of receiving area
Time frame: 28 days
Area of Epithelization of wound healing, measured in mm2
Time frame: 28 days
discomfort measured using Visual Analogue Scale
Time frame: 12 months
Measured with photographic analysis
Time frame: 12 months
OHIp - 14 short version
Time frame: 12 months
Distance between cementum-enamel junction and bottom of sulcus / pocket, measured in millimeters
Time frame: 12 months
Distance between cementum-enamel junction and gingival margin, measured in millimeters
Time frame: 12 months
percentage of sites which bled upon probing
University of Sao Paulo
Other
Acronym: EFFECT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07662447
Gingival Diseases, Gingival Recession
Ajman, Ajman Emirate, United Arab Emirates
View Trial DetailsNCT07624591
Gingival Diseases, Gingival Recession
Ho Chi Minh City, Vietnam
View Trial DetailsNCT04179448
Gingival Diseases, Gingival Recession
Birmingham, Alabama, United States
View Trial DetailsNCT06044870
Gingival Diseases, Gingival Recession
Cairo, Egypt
View Trial Details