Palatal Shield Technique for Pain Reduction and Wound Healing After Free Gingival Graft Surgery
Palatal Donor Site Wound Healing · Postoperative Pain
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 28 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
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.
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento simple
palatal shield group
Collagen Sponge + Flowable Composite Palatal Shield
Procedure: Palatal Shield Technique Using Flowable Composite Resin
collagen sponge group
Collagen Sponge Stabilized With Sutures
Procedure: Collagen Sponge Dressing Stabilized With Sutures
Palatal Shield Technique Using Flowable Composite Resin PROCEDURE
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.
Collagen Sponge Dressing Stabilized With Sutures PROCEDURE
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 evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
postoperative pain intensity
Plazo: 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
Medidas secundarias
palatal donor site wound size
Plazo: 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).
early palatal wound healing
Plazo: 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
Palatal Donor Site Re-epithelialization
Plazo: 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).
palatal donor site color match
Plazo: 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.
patient satisfaction
Plazo: 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.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
Periodontology Clinics, Faculty of Dentistry, Cairo UniversityCairo, Cairo Governorate, EgyptReclutando
Equipo y fechas
- Patrocinador principal
- Sameh Samy
- Inicio del estudio
- 5 jun 2026 Real
- Finalización primaria
- 2027-03 Estimado
- Finalización del estudio
- 2027-03 Estimado
- Primera publicación
- 9 nov 2026 Real
- Última actualización
- 9 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
Evaluation of Novel Palatal Shield Technique for Improved Donor Site Wound Healing After Free Gingival Graft Surgery: A Randomized Controlled Trial
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 9 nov 2026