Reharvested Free Gingival Grafts: 3D Shrinkage and Histological Changes
25 мая 2026 г. обновлено: 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.
Обзор исследования
Статус
Еще не набирают
Вмешательство/лечение
Тип исследования
Наблюдательный
Регистрация (Оцененный)
20
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Ebru Dilmen
- Номер телефона: +905435673736
- Электронная почта: 231115001@st.biruni.edu.tr
Места учебы
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Istanbul, Турция (Туркие)
- Biruni University
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Да
Метод выборки
Невероятностная выборка
Исследуемая популяция
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.
Описание
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.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
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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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Трехмерные изменения свободного десневого трансплантата
Временное ограничение: Базовый уровень
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Для оценки изменений размеров трансплантата будет использоваться внутриротовой цифровой сканер.
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Базовый уровень
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Трехмерные изменения свободного десневого трансплантата.
Временное ограничение: 1-й месяц
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Для оценки изменений размеров трансплантата будет использоваться внутриротовой цифровой сканер.
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1-й месяц
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The three-dimensional changes of free gingival graft
Временное ограничение: 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.
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Keratinized mucosa width
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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,
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Учебный стул: Ayşe Ege Selman, Biruni University, Faculty of Dentistry, Department of Periodontology
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- 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.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
15 июня 2026 г.
Первичное завершение (Оцененный)
15 июня 2027 г.
Завершение исследования (Оцененный)
15 сентября 2027 г.
Даты регистрации исследования
Первый отправленный
18 мая 2026 г.
Впервые представлено, что соответствует критериям контроля качества
25 мая 2026 г.
Первый опубликованный (Действительный)
1 июня 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
1 июня 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
25 мая 2026 г.
Последняя проверка
1 мая 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- 2024- BİAEK/17-32
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .