Insufficient Keratinized Gingiva
Conditions
Keywords
free gingival graft
Brief summary
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.
Interventions
PROCEDUREFree gingival graft
Following 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.
PROCEDURERe-harvested free gingival graft
Following 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.
Sponsors
Biruni University
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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, * Mean plaque index (PI) score \<1 following non-surgical periodontal therapy (NSPT), * No use of antibiotics or anti-inflammatory drugs within the last 3 months, * Not being pregnant or breastfeeding, * Willingness to participate in the study by signing the informed consent form.
Exclusion criteria
* 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, * History of chemotherapy or radiotherapy within the last 6 months, * History of antibiotic use within the last 3 months, * Palatal mucosal thickness \<3 mm or presence of palatal torus, * Presence of deep and narrow (U-shaped) or shallow palatal vaults interfering with palatal measurements, * Non-compliance with treatment or follow-up protocols.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The three-dimensional changes of free gingival graft | Baseline | An intraoral digital scanner will be used to assess the graft's dimensions alterations. |
| The three-dimensional changes of free gingival graft. | 1st month | An intraoral digital scanner will be used to assess the graft's dimensions alterations. |
| Histological alterations in free gingival grafts | Baseline (initial graft harvesting procedure) | Histomorphometric and immunohistochemical evaluation of epithelial thickness and Type I and Type III collagen ratios in free gingival graft samples obtained from the palatal donor site. |
| Histological alterations in re-harvested free gingival grafts | 63 days after the initial surgery (re-harvesting procedure) | Histomorphometric and immunohistochemical evaluation of epithelial thickness and Type I and Type III collagen ratios in free gingival graft samples reharvested from the same palatal donor site. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Keratinized mucosa width | Baseline (prior to therapy) | 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 | Baseline (prior to therapy) | 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. |
| Gingival Thickness | Baseline | Following local anesthesia, measurements will be performed at the distobuccal, midbuccal, and mesiobuccal aspects of the teeth in the recipient area by inserting a #20 spreader with a silicone stopper perpendicular to the gingival surface, 2 mm apical to the gingival margin. After hard tissue contact is achieved, the distance between the tip of the spreader and the silicone stopper will be measured using a digital caliper. The mean value of the measurements will be recorded. |
| Landry Healing Index | 7th day | Healing at the recipient site will be evaluated according to tissue color, presence of bleeding and granulation tissue, suppuration, and epithelialization. Healing will be scored on a scale ranging from 1 to 5. |
| Growth factor levels in wound fluid | 3rd day | Wound fluid samples will be collected from the mesiocoronal, distocoronal, mesioapical, and distoapical margins of the surgical recipient site using paper strips (Periopaper®, Oraflow, Plainview, NY, USA). The strips will be gently placed at the relevant sites for 30 seconds while avoiding mechanical trauma. VEGF-A, PDGF, and TGF-β1 levels will be evaluated. |
| Protein expression levels in free gingival grafts, | Baseline (initial graft harvesting procedure) | Biochemical evaluation of type I collagen, type III collagen, and α-SMA protein expression levels in free gingival graft samples obtained from the donor site. |
| Protein expression levels in free gingival grafts | 63 days after the initial surgery (re-harvesting procedure) | Biochemical evaluation of type I collagen, type III collagen, and α-SMA protein expression levels in free gingival graft samples obtained from the same donor site. |
| Patient reported outcomes | 10th day | After the surgical procedure, patients will be asked to complete a form consisting of 3 items: (1) assessment of the intensity of postoperative pain/discomfort (by Visual Analog Scale), (2) duration of pain (in days) and (3) number of analgesic tablets taken. |
Countries
Turkey (Türkiye)
Contacts
CONTACTEbru Dilmen
STUDY_CHAIRAyşe Ege Selman
Biruni University, Faculty of Dentistry, Department of Periodontology
Outcome results
None listed