- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07568327
Free Gingival Graft Patients' Treatment Perception and Experience
Patient Experience and Treatment Perception in Patients Undergoing Free Gingival Graft: A Retrospective Survey Study.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
Background and Rationale: Free gingival graft (FGG) is a widely preferred mucogingival procedure in periodontal plastic surgery, aimed at increasing keratinized tissue width and improving gingival morphology. While FGG is highly effective for indications such as preventing gingival recession and enhancing oral hygiene maintenance, it requires a secondary surgical site (donor area), which can lead to postoperative pain, tissue morbidity, and reduced patient comfort. Current literature often focuses on short-term clinical outcomes, leaving long-term patient-reported outcome measures (PROMs) and perceptions insufficiently explored.
Objectives:The primary objective of this study is to retrospectively evaluate the postoperative experiences, satisfaction levels, and overall surgical perceptions of individuals who underwent FGG surgery. Specifically, the study aims to investigate the willingness of patients to undergo the procedure again, should it be necessary in the future.
Methodology: This is a retrospective, non-interventional, observational, and cross-sectional study conducted at Istanbul Aydin University, Faculty of Dentistry, Department of Periodontology. The study population includes patients who underwent FGG surgery between January 2014 and May 2024, with at least one year having passed since the operation.Data collection involves two stages:
- Archive Review: Patient demographics, smoking status, systemic health, and surgical details (e.g., complications, donor site technique) are retrieved from institutional records.
- Telephone Survey: A semi-structured survey is administered via telephone to assess patient-reported outcomes, including pain levels, satisfaction, analgesic requirements, and aesthetic perceptions.
Тип исследования
Регистрация (Действительный)
Контакты и местонахождение
Места учебы
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Turkey
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Istanbul, Turkey, Турция (Туркие), 34295
- Istanbul Aydin University, Faculty of Dentistry, Department of Periodontology
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- Individuals who underwent Free Gingival Graft (FGG) surgery at Istanbul Aydin University, Faculty of Dentistry, Department of Periodontology; who accurately remember the surgical site and grant permission to use their patient records containing demographic and surgical data.
- Patients who have undergone periodontal plastic surgery due to an FGG procedure only once.
- Patients whose records contain complete information regarding the graft harvesting technique from the palatal donor site, including the date of the procedure and any complications within the first month following surgery.
- Patients who have not previously undergone any other surgical procedure in the palatal region.
Exclusion Criteria:
- Individuals who have not undergone FGG surgery.
- Patients who have undergone periodontal plastic surgery more than once.
- Patients who underwent FGG surgery but have missing or incomplete information in their medical records.
- Patients who have previously undergone any other surgical procedure in the palatal region.
- Patients who have previously received a different periodontal surgical treatment in the area where the relevant teeth are located.
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
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Free Gingival Graft Patients
Patients who underwent free gingival graft (FGG) surgery at the Department of Periodontology, Faculty of Dentistry, Istanbul Aydın University, between January 2014 and May 2024
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A surgical procedure performed to increase the amount of keratinised gingival tissue and improve periodontal health.
The study examines the postoperative experiences and satisfaction levels of patients who have undergone this procedure.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Patient Satisfaction and Willingness to Undergo the Procedure Again
Временное ограничение: At least 1 year post-operation (Range: 1 to 11 years, based on surgeries performed between January 2014 and May 2024).
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This measure evaluates the overall satisfaction of patients who underwent Free Gingival Graft (FGG) surgery and their willingness to repeat the procedure if necessary in the future.
The assessment is conducted through a semi-structured retrospective telephone survey that covers postoperative pain, complications, aesthetic perception, and overall treatment experience.
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At least 1 year post-operation (Range: 1 to 11 years, based on surgeries performed between January 2014 and May 2024).
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Соавторы и исследователи
Спонсор
Публикации и полезные ссылки
Общие публикации
- Wessel JR, Tatakis DN. Patient outcomes following subepithelial connective tissue graft and free gingival graft procedures. J Periodontol. 2008 Mar;79(3):425-30. doi: 10.1902/jop.2008.070325.
- Griffin TJ, Cheung WS, Zavras AI, Damoulis PD. Postoperative complications following gingival augmentation procedures. J Periodontol. 2006 Dec;77(12):2070-9. doi: 10.1902/jop.2006.050296.
- Camargo PM, Melnick PR, Kenney EB. The use of free gingival grafts for aesthetic purposes. Periodontol 2000. 2001;27:72-96. doi: 10.1034/j.1600-0757.2001.027001072.x. No abstract available.
- 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.
- Tavelli L, Barootchi S, Di Gianfilippo R, Kneifati A, Majzoub J, Stefanini M, Zucchelli G, Wang HL. Patient experience of autogenous soft tissue grafting has an implication for future treatment: A 10- to 15-year cross-sectional study. J Periodontol. 2021 May;92(5):637-647. doi: 10.1002/JPER.20-0350. Epub 2020 Oct 3.
- Curtis JW Jr, McLain JB, Hutchinson RA. The incidence and severity of complications and pain following periodontal surgery. J Periodontol. 1985 Oct;56(10):597-601. doi: 10.1902/jop.1985.56.10.597.
- Brasher WJ, Rees TD, Boyce WA. Complications of free grafts of masticatory mucosa. J Periodontol. 1975 Mar;46(3):133-8. doi: 10.1902/jop.1975.46.3.133.
- Agudio G, Nieri M, Rotundo R, Cortellini P, Pini Prato G. Free gingival grafts to increase keratinized tissue: a retrospective long-term evaluation (10 to 25 years) of outcomes. J Periodontol. 2008 Apr;79(4):587-94. doi: 10.1902/jop.2008.070414.
- Corn H. Periosteal separation-its clinical significance. The Journal of Periodontology. 1962;33(2):140-53
- Carranza FA Jr, Carraro JJ. Mucogingival techniques in periodontal surgery. J Periodontol. 1970 May;41(5):294-9. doi: 10.1902/jop.1970.41.5.294. No abstract available.
- Miller PD Jr. Regenerative and reconstructive periodontal plastic surgery. Mucogingival surgery. Dent Clin North Am. 1988 Apr;32(2):287-306.
- Glossary of periodontal terms: American Academy of Periodontology; 1992.
- Miller PD Jr. Root coverage grafting for regeneration and aesthetics. Periodontol 2000. 1993 Feb;1(1):118-27. No abstract available.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 145/2025
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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