Palatal Shield Technique for Pain Reduction and Wound Healing After Free Gingival Graft Surgery
Evaluation of Novel Palatal Shield Technique for Improved Donor Site Wound Healing After Free Gingival Graft Surgery: A Randomized Controlled Trial
This randomized controlled clinical trial aims to evaluate the effectiveness of a novel palatal shield technique in reducing postoperative pain and improving wound healing after free gingival graft surgery.
A total of 28 adult participants undergoing palatal tissue harvesting are planned to be enrolled and randomly assigned to two groups.
The experimental group receives a collagen sponge covered by a protective palatal shield made of flowable composite resin, while the control group receives a collagen sponge stabilized with sutures alone.
The primary outcome is postoperative pain, assessed using a 0-10 pain scale. Secondary outcomes include wound size, early wound healing, re-epithelialization, tissue color match, and patient satisfaction.
Postoperative clinical assessments are planned through 30 days after surgery. The study aims to determine whether the palatal shield technique provides better pain control and wound healing compared with conventional collagen sponge dressing.
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Cairo Governorate
-
Cairo, Cairo Governorate, Egipto
- Reclutamiento
- Periodontology Clinics, Faculty of Dentistry, Cairo University
-
Contacto:
- sameh s Hassan, BDS
- Número de teléfono: +201014142357
- Correo electrónico: sameh.samy@dentistry.cu.edu.eg
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Adult patients aged 18 years or older.
- Patients with no history of previous palatal tissue harvesting.
- Patients demonstrating good compliance with plaque control instructions following initial periodontal therapy.
- Patients requiring soft tissue augmentation using free gingival grafts (FGG) or de-epithelialized free gingival grafts for gingival recession coverage, vestibuloplasty, or increasing the width of keratinized tissue around teeth.
- Patients providing informed consent to participate in the study. Exclusion Criteria: - Patients with systemic diseases.
- Pregnant or breastfeeding women.
- Patients with oral lesions involving the palate.
- Patients using dental prostheses covering the palate.
- Smokers.
- Patients taking anticoagulant medications.
- Patients with abnormalities affecting the wound healing process.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: palatal shield group
Collagen Sponge + Flowable Composite Palatal Shield |
A resorbable collagen sponge is placed over the palatal donor site following free gingival graft harvesting and stabilized with sutures. Flowable composite resin is then applied and light-cured to form a protective palatal shield retained by the adjacent teeth. |
|
Comparador activo: collagen sponge group
Collagen Sponge Stabilized With Sutures |
Following free gingival graft harvesting, a resorbable collagen sponge is trimmed to fit the palatal donor site and stabilized using sutures without additional composite resin coverage. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
postoperative pain intensity
Periodo de tiempo: Postoperative Days 1, 3, 7, 14, 21, and 30
|
Postoperative pain intensity will be assessed using a 0-10 Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity |
Postoperative Days 1, 3, 7, 14, 21, and 30
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
palatal donor site wound size
Periodo de tiempo: Immediately After Surgery and on Postoperative Days 1, 3, 7, 14, 21, and 30
|
Wound size will be assessed by measuring the length, width, and depth of the palatal donor site using a periodontal probe. Measurements will be recorded in millimeters (mm). |
Immediately After Surgery and on Postoperative Days 1, 3, 7, 14, 21, and 30
|
|
early palatal wound healing
Periodo de tiempo: Postoperative Days 1, 3, 7, and 14
|
Early wound healing at the palatal donor site will be assessed by clinical visual inspection using the Early Wound Healing Index (EHI), as described by Wachtel et al. (2003). Healing will be evaluated using a categorical score ranging from 0 to 5, according to the study protocol |
Postoperative Days 1, 3, 7, and 14
|
|
Palatal Donor Site Re-epithelialization
Periodo de tiempo: Postoperative Days 1, 3, 7, and 14
|
Re-epithelialization of the palatal donor site will be assessed by clinical visual inspection using a 3-point categorical scale: 1 = No re-epithelialization, 2 = Partial re-epithelialization, and 3 = Complete re-epithelialization. Higher scores indicate more complete epithelial coverage, according to Keceli et al. (2015). |
Postoperative Days 1, 3, 7, and 14
|
|
palatal donor site color match
Periodo de tiempo: Postoperative Days 1, 3, 7, 14, 21, and 30
|
Palatal donor site color match will be assessed by visual comparison with the adjacent native palatal mucosa using a 4-point categorical Color Match Rating Scale: 1 = Poor, 2 = Fair, 3 = Good, and 4 = Excellent. The minimum score is 1 and the maximum score is 4. Higher scores indicate better color matching. |
Postoperative Days 1, 3, 7, 14, 21, and 30
|
|
patient satisfaction
Periodo de tiempo: Postoperative Days 1, 3, 7, 14, 21, and 30
|
Patient satisfaction will be evaluated using a three-item questionnaire assessing satisfaction with the surgical results, willingness to undergo the procedure again, and willingness to recommend the procedure to others. Responses will be recorded using a 7-point response scale. |
Postoperative Days 1, 3, 7, 14, 21, and 30
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
- PER 3-3-1-1
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Individual participant data will not be shared with external researchers. Study data will be accessible only to the principal investigator and supervisors and will be stored securely to protect participant confidentiality.
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. .