- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07568327
Free Gingival Graft Patients' Treatment Perception and Experience
Patient Experience and Treatment Perception in Patients Undergoing Free Gingival Graft: A Retrospective Survey Study.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Turkey
-
Istanbul, Turkey, Turquía (Türkiye), 34295
- Istanbul Aydin University, Faculty of Dentistry, Department of Periodontology
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Patient Satisfaction and Willingness to Undergo the Procedure Again
Periodo de tiempo: At least 1 year post-operation (Range: 1 to 11 years, based on surgeries performed between January 2014 and May 2024).
|
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.
|
At least 1 year post-operation (Range: 1 to 11 years, based on surgeries performed between January 2014 and May 2024).
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 145/2025
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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. .