Reharvested Free Gingival Grafts: 3D Shrinkage and Histological Changes
25 de mayo de 2026 actualizado por: Ayse Ege SELMAN, Biruni University
Three-Dimensional Assessment of Graft Shrinkage in Relation to Histological Alterations in Reharvested Free Gingival Grafts From the Same Palatal Donor Site
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
De observación
Inscripción (Estimado)
20
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Ebru Dilmen
- Número de teléfono: +905435673736
- Correo electrónico: 231115001@st.biruni.edu.tr
Ubicaciones de estudio
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Istanbul, Turquía (Türkiye)
- Biruni University
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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First free gingival graft
Recipient sites treated with free gingival grafts harvested from the palatal donor site during the initial surgical procedure.
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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.
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Re-harvested free gingival graft
Recipient sites treated with free gingival grafts re-harvested from the same palatal donor site 63 days after the initial surgery.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Los cambios tridimensionales del injerto gingival libre.
Periodo de tiempo: Base
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Se utilizará un escáner digital intraoral para evaluar las alteraciones de las dimensiones del injerto.
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Base
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Los cambios tridimensionales del injerto gingival libre.
Periodo de tiempo: 1er mes
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Se utilizará un escáner digital intraoral para evaluar las alteraciones de las dimensiones del injerto.
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1er mes
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The three-dimensional changes of free gingival graft
Periodo de tiempo: Postoperative baseline (immediately after surgery)
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An intraoral digital scanner will be used to assess the graft's dimensions alterations.
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Postoperative baseline (immediately after surgery)
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The three-dimensional changes of free gingival graft.
Periodo de tiempo: 3rd month
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An intraoral digital scanner will be used to assess the graft's dimensions alterations.
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3rd month
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Histological alterations in free gingival grafts
Periodo de tiempo: Baseline (initial graft harvesting procedure)
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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.
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Baseline (initial graft harvesting procedure)
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Histological alterations in re-harvested free gingival grafts
Periodo de tiempo: 63 days after the initial surgery (re-harvesting procedure)
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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.
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63 days after the initial surgery (re-harvesting procedure)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Keratinized mucosa width
Periodo de tiempo: Baseline (prior to therapy)
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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.
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Baseline (prior to therapy)
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Keratinized mucosa width
Periodo de tiempo: 1st month
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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.
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1st month
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Keratinized mucosa width
Periodo de tiempo: 3rd month
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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.
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3rd month
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Gingival Recession Width
Periodo de tiempo: Baseline (prior to therapy)
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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.
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Baseline (prior to therapy)
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Gingival Recession Width
Periodo de tiempo: 1st month
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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.
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1st month
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Gingival Recession Width
Periodo de tiempo: 3rd month
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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.
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3rd month
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Gingival Thickness
Periodo de tiempo: Baseline
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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.
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Baseline
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Gingival Thickness
Periodo de tiempo: 3rd month
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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.
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3rd month
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Landry Healing Index
Periodo de tiempo: 7th day
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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.
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7th day
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Landry Healing Index
Periodo de tiempo: 14th day
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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.
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14th day
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Landry Healing Index
Periodo de tiempo: 28th day
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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.
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28th day
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Growth factor levels in wound fluid
Periodo de tiempo: 3rd day
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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.
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3rd day
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Growth factor levels in wound fluid
Periodo de tiempo: 7th day
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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.
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7th day
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Protein expression levels in free gingival grafts,
Periodo de tiempo: Baseline (initial graft harvesting procedure)
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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.
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Baseline (initial graft harvesting procedure)
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Protein expression levels in free gingival grafts
Periodo de tiempo: 63 days after the initial surgery (re-harvesting procedure)
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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.
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63 days after the initial surgery (re-harvesting procedure)
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Patient reported outcomes
Periodo de tiempo: 10th day
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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.
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10th day
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Silla de estudio: Ayşe Ege Selman, Biruni University, Faculty of Dentistry, Department of Periodontology
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Zuhr O, Baumer D, Hurzeler M. The addition of soft tissue replacement grafts in plastic periodontal and implant surgery: critical elements in design and execution. J Clin Periodontol. 2014 Apr;41 Suppl 15:S123-42. doi: 10.1111/jcpe.12185.
- Lang NP, Loe H. The relationship between the width of keratinized gingiva and gingival health. J Periodontol. 1972 Oct;43(10):623-7. doi: 10.1902/jop.1972.43.10.623. No abstract available.
- Guglielmoni P, Promsudthi A, Tatakis DN, Trombelli L. Intra- and inter-examiner reproducibility in keratinized tissue width assessment with 3 methods for mucogingival junction determination. J Periodontol. 2001 Feb;72(2):134-9. doi: 10.1902/jop.2001.72.2.134.
- Soileau KM, Brannon RB. A histologic evaluation of various stages of palatal healing following subepithelial connective tissue grafting procedures: a comparison of eight cases. J Periodontol. 2006 Jul;77(7):1267-73. doi: 10.1902/jop.2006.050129.
- Pippi R. Post-Surgical Clinical Monitoring of Soft Tissue Wound Healing in Periodontal and Implant Surgery. Int J Med Sci. 2017 Jul 18;14(8):721-728. doi: 10.7150/ijms.19727. eCollection 2017.
- Parvini P, Galarraga-Vinueza ME, Obreja K, Magini RS, Sader R, Schwarz F. Prospective study assessing three-dimensional changes of mucosal healing following soft tissue augmentation using free gingival grafts. J Periodontol. 2021 Mar;92(3):400-408. doi: 10.1002/JPER.19-0640. Epub 2020 Aug 21.
- Tavelli L, Barootchi S, Stefanini M, Zucchelli G, Giannobile WV, Wang HL. Wound healing dynamics, morbidity, and complications of palatal soft-tissue harvesting. Periodontol 2000. 2023 Jun;92(1):90-119. doi: 10.1111/prd.12466. Epub 2022 Dec 30.
- Silva CO, Ribeiro Edel P, Sallum AW, Tatakis DN. Free gingival grafts: graft shrinkage and donor-site healing in smokers and non-smokers. J Periodontol. 2010 May;81(5):692-701. doi: 10.1902/jop.2010.090381.
- Hatipoglu H, Keceli HG, Guncu GN, Sengun D, Tozum TF. Vertical and horizontal dimensional evaluation of free gingival grafts in the anterior mandible: a case report series. Clin Oral Investig. 2007 Jun;11(2):107-13. doi: 10.1007/s00784-006-0084-x. Epub 2007 Feb 9.
- Keskiner I, Aydogdu A, Balli U, Kaleli AE. Quantitative changes in palatal donor site thickness after free gingival graft harvesting: a pilot study. J Clin Periodontol. 2016 Nov;43(11):976-984. doi: 10.1111/jcpe.12592. Epub 2016 Sep 9.
- Gumus P, Buduneli E. Graft stabilization with cyanoacrylate decreases shrinkage of free gingival grafts. Aust Dent J. 2014 Mar;59(1):57-64. doi: 10.1111/adj.12149. Epub 2014 Feb 4.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
15 de junio de 2026
Finalización primaria (Estimado)
15 de junio de 2027
Finalización del estudio (Estimado)
15 de septiembre de 2027
Fechas de registro del estudio
Enviado por primera vez
18 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
25 de mayo de 2026
Publicado por primera vez (Actual)
1 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
25 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 2024- BİAEK/17-32
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .