About this trial
The purpose of this study is to evaluate the dimensional stability of free gingival grafts (FGG) and to investigate the relationship between graft shrinkage (GS) and the histological and biochemical characteristics of grafts reharvested from the same palatal donor site. The primary objective is to investigate the relationship between histological alterations in grafts reharvested from the same donor site and graft shrinkage at the recipient site.
This study is designed as a split-mouth study in which FGGs are applied to contralateral recipient sites within the same patient. Each participant will receive two grafts: an initial graft harvested from the palatal donor site and a second graft reharvested from the same donor site 63 days after the initial procedure.
Graft dimensional changes will be evaluated using three-dimensional digital measurements. Intraoral digital scans will be obtained at baseline, immediately after surgery, and at 1 and 3 months postoperatively. GS will be assessed through superimposition of digital models.
In addition, histological, histomorphometric, and immunohistochemical analyses will be performed on tissue samples obtained from the donor site to evaluate collagen characteristics and epithelial structure. Furthermore, protein expression levels of specific markers, including collagen type I, collagen type III, and alpha-smooth muscle actin (α-SMA), will be assessed. Early wound healing at the recipient site will be evaluated using the Landry healing index at postoperative days 7, 14, and 28. In addition, biological mediators, including transforming growth factor beta 1 (TGF-β1), vascular endothelial growth factor A (VEGF-A), and platelet-derived growth factor (PDGF), will be analyzed in wound exudate samples obtained from the recipient site to biochemically assess the early healing process.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Individuals aged between 18 and 65 years,
Absence of any systemic disease that may adversely affect periodontal health and wound healing,
Non-smokers,
Periodontally healthy individuals,
Disqualifiers
Presence of any systemic disease contraindicating surgical procedures,
Use of medications or supplements affecting bleeding or wound healing,
Presence of uncontrolled diabetes mellitus (HbA1c >7),
Pregnancy or breastfeeding,
Trial population
Systemically healthy, non-smoking individuals aged 18-65 years with insufficient keratinized gingiva (\<2 mm; Lang \& Löe, 1972) involving the bilateral mandibular canine and/or premolar regions will be included in the study.
Trial design
Other
Prospective
Treatments tested in this trial
Free gingival graft
Procedure/SurgeryFollowing adequate local anesthesia, a horizontal incision will be made at the level of the mucogingival junction to prepare the recipient bed. A split-thickness flap will be elevated without disturbing the periosteum. A free gingival graft will be harvested from the palatal donor site during the initial surgical procedure. The harvested graft will then be transferred to the recipient site, shaped to the desired dimensions, and stabilized with sutures.
Re-harvested free gingival graft
Procedure/SurgeryFollowing adequate local anesthesia, a horizontal incision will be made at the level of the mucogingival junction to prepare the recipient bed. A split-thickness flap will be elevated without disturbing the periosteum. A free gingival graft will be reharvested from the same palatal donor site 63 days after the initial surgery. The harvested graft will then be transferred to the recipient site, shaped to the desired dimensions, and stabilized with sutures.
Treatment groups
Trial outcomes
Primary outcomes
The three-dimensional changes of free gingival graft
An intraoral digital scanner will be used to assess the graft's dimensions alterations.
The three-dimensional changes of free gingival graft
An intraoral digital scanner will be used to assess the graft's dimensions alterations.
The three-dimensional changes of free gingival graft.
An intraoral digital scanner will be used to assess the graft's dimensions alterations.
The three-dimensional changes of free gingival graft.
An intraoral digital scanner will be used to assess the graft's dimensions alterations.
Secondary outcomes
Keratinized mucosa width
The apical-coronal distance from the mucosal margin to the mucogingival junction (MGJ) Measurements will be made at three points on tooth (mesiobuccal, midbuccal, distobuccal) using a periodontal probe.
Keratinized mucosa width
The apical-coronal distance from the mucosal margin to the mucogingival junction (MGJ) Measurements will be made at three points on tooth (mesiobuccal, midbuccal, distobuccal) using a periodontal probe.
Keratinized mucosa width
The apical-coronal distance from the mucosal margin to the mucogingival junction (MGJ) Measurements will be made at three points on tooth (mesiobuccal, midbuccal, distobuccal) using a periodontal probe.
Gingival Recession Width
The widest horizontal distance between the mesial and distal gingival margins of the recession defect at the level of the cementoenamel junction (CEJ) will be measured using a periodontal probe held horizontally.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: