Evaluation of Post-operative Pain After Stabilization of Free Gingival Graft for Keratinized Tissue Augmentation Around Natural Teeth Using Titanium Tacks Versus Standard Suturing Technique.
12 de junio de 2026 actualizado por: Karim Abdelrahim Mohamed Abdelsamad
Clinical Evaluation of Titanium Tacks Used for the Stabilization of Free Gingival Graft in Gingival Augmentation Around Natural Teeth: A Randomized Controlled Clinical Trial
The goal of this clinical trial is to learn whether titanium tacks can be used as an alternative to sutures for stabilization of free gingival grafts (FGG) around natural teeth. It will also evaluate the effect of each stabilization technique on patient comfort and clinical outcomes.
The main questions it aims to answer are:
- Does stabilization of free gingival grafts using titanium tacks reduce post-operative pain compared with conventional suturing?
- Does stabilization of free gingival grafts using titanium tacks affect clinical outcomes such as keratinized tissue width, gingival thickness, graft dimensions, procedure time, plaque accumulation, and interference with daily activities?
Researchers will compare free gingival graft stabilization using titanium tacks with the conventional suturing technique to determine whether titanium tacks provide comparable or improved outcomes.
Participants will:
- Receive a free gingival graft around natural teeth requiring augmentation of keratinized gingival tissue.
- Be assigned to have the graft stabilized either with titanium tacks or with conventional resorbable sutures.
- Attend scheduled follow-up visits for clinical examinations and measurements.
- Report their post-operative pain levels using a Visual Analogue Scale (VAS).
- Complete assessments related to daily life interference during the healing period.
- Undergo evaluation of keratinized tissue width, gingival thickness, graft dimensions, plaque index, and procedure time.
Descripción general del estudio
Estado
Reclutamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
24
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Cairo Governorate
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Cairo, Cairo Governorate, Egipto, 11553
- Reclutamiento
- Faculty of Dentistry and Oral Medicine, Cairo University, Cairo.
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Contacto:
- Karim Abdelsamad
- Número de teléfono: 00201006521672
- Correo electrónico: karim.abdelsamad@dentistry.cu.edu.eg
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Patients age 18 years or older.
- Patients with healthy systemic condition.
- Indication for FGG treatment (i.e., difficulty or discomfort during oral hygiene; gingival margin mobility; high muscle attachment and/or frenum pull; shallow vestibule and gingival recession) around natural teeth.
- Keratinized tissue width (KTW) < 2 mm.
- Good oral hygiene.
- Cooperative patients.
Exclusion Criteria:
- Pregnant females.
- Smokers: a contraindication for any plastic periodontal surgery.
- Unmotivated and uncooperative patients with poor oral hygiene.
- Patients with habits that may compromise the longevity and affect the result of the study as parafunctional habits.
- Patients who have undergone periodontal surgery in the same area within 6 months.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿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 |
|---|---|
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Experimental: Free gingival grafting (FGG) using titanium tacks for stabilization
According to the graft size, 2 to 5 titanium tacks will be used to stabilize and secure the free gingival graft in place to the periosteum at the recipient bed as needed, through anchoring in inter-septal bone and avoiding teeth roots.
The FGG will be stretched by fixing one tack at its distal end, then another tack at its mesial one, followed by the other tacks as required.
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Stabilization of the free gingival autograft in place using a 5-0 or 6-0 resorbable Prolene suture using a combination of two interrupted sutures, anchoring the grafted tissue to the base of the anatomical papillae, and a horizontal mattress compression suture anchored to the periosteum apical to the bone dehiscence and suspended around the palatal or lingual cingulum of the tooth with the recession defect, allowing for intimate contact ensuring proper perfusion and consequent revascularization of the graft.
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Comparador activo: Free gingival grafting (FGG) using sutures for stabilization
Stabilization of the free gingival autograft in place using a 5-0 or 6-0 resorbable Prolene suture using a combination of two interrupted sutures, anchoring the grafted tissue to the base of the anatomical papillae, and a horizontal mattress compression suture anchored to the periosteum apical to the bone dehiscence and suspended around the palatal or lingual cingulum of the tooth with the recession defect, allowing for intimate contact ensuring proper perfusion and consequent revascularization of the graft.
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According to the graft size, 2 to 5 titanium tacks will be used to stabilize and secure the free gingival graft in place to the periosteum at the recipient bed as needed, through anchoring in inter-septal bone and avoiding teeth roots.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Postoperative pain
Periodo de tiempo: Daily for the first 7 days post-surgery.
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Visual Analogue Scale (VAS) with numerical scale from 0 to 10 ('no pain' to 'worst pain imaginable') measured daily for the first 1 week postoperatively.
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Daily for the first 7 days post-surgery.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Keratinized tissue width (KTW)
Periodo de tiempo: Week 12, Week 24
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Will be measured from the MGJ to the free gingival margin.
The MGJ will be identified using the roll technique.
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Week 12, Week 24
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Intra-operative/procedure time (PT)
Periodo de tiempo: During the free gingival graft stabilization procedure
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Will be measured using a stopwatch from the beginning till the end of each procedure.
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During the free gingival graft stabilization procedure
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Daily life interference
Periodo de tiempo: Daily for the first 7 days post-surgery.
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It is based on the level of interference of surgical procedure on the patient's normal daily life for the first week after surgery.
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Daily for the first 7 days post-surgery.
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Gingival thickness
Periodo de tiempo: Week 12, Weeks 24.
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An endodontic file and a 3 mm diametersilicon disc stop will be used to measure gingival thickness 2mm apical to the gingival border.
The file will be inserted into the soft tissue with mild pressure, perpendicular to the mucosal surface, until a firm surface is felt.
The silicon disc stop will be then pressed against the soft tissue, with the coronal border covering the soft tissue boundary.
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Week 12, Weeks 24.
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Post-operative Pain [Indirect]
Periodo de tiempo: Daily for the first 7 days post-surgery.
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It is based on the amount of analgesics patient consumes, only if needed, during the first week after surgery.
This will be measured by the number of pills consumed by the patient after both the pretreatment and 6h post-treatment doses.
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Daily for the first 7 days post-surgery.
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Plaque Index
Periodo de tiempo: Week 12, Week 24.
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Week 12, Week 24.
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Graft dimensions
Periodo de tiempo: Week 12, Week 24.
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Will be measured from standardized images using "Image J Software" for standardization of measurements and readings.
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Week 12, Week 24.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
17 de marzo de 2025
Finalización primaria (Estimado)
1 de febrero de 2027
Finalización del estudio (Estimado)
1 de julio de 2027
Fechas de registro del estudio
Enviado por primera vez
12 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
12 de junio de 2026
Publicado por primera vez (Actual)
17 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
12 de junio de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 28/1/2025
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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