Pain After Diode Laser Frenectomy in Children (PED-FREN)
Postoperative Pain Assessment Following Diode Laser-Assisted Frenectomy in Pediatric Patients: A Prospective Single-Group Clinical Study
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Diode laser-assisted frenectomy has become an increasingly preferred technique in pediatric dentistry because it provides effective soft tissue management with reduced intraoperative bleeding, minimal tissue trauma, and improved postoperative comfort. Although postoperative pain is an important determinant of treatment acceptance and patient satisfaction in children, limited evidence is available regarding the temporal pattern of pain following diode laser-assisted frenectomy and the agreement between different pediatric pain assessment instruments.
This prospective single-group clinical study was conducted at the Pediatric Dentistry Clinic of Afyonkarahisar Health Sciences University. Pediatric patients aged 8 to 14 years requiring diode laser-assisted frenectomy were consecutively enrolled after obtaining written informed consent from their parents or legal guardians. All surgical procedures were performed by the same clinician using a diode laser according to the standard clinical protocol. No comparison group was included.
The primary objective of the study is to evaluate postoperative pain during the first seven postoperative days. Pain intensity is assessed once daily using the Wong-Baker FACES Pain Rating Scale, the Modified Emoji Pain Scale (MEPS), and gender-specific pediatric pain scales. The study also aims to determine the level of agreement and correlation between these pain assessment instruments and to characterize postoperative pain trajectories throughout the first postoperative week.
The findings are expected to improve the understanding of postoperative pain following diode laser-assisted frenectomy in children and to provide evidence regarding the clinical applicability and consistency of different pediatric pain assessment tools. The results may contribute to the selection of appropriate pain assessment methods in pediatric dental practice and support postoperative pain monitoring in children undergoing soft tissue laser surgery.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Özgür Doğan, Assoc. Prof. Dr.
- Número de teléfono: 905052777520
- Correo electrónico: ozgurdogan1984@gmail.com
Ubicaciones de estudio
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Afyonkarahisar, Turquía (Türkiye), 03300
- Afyonkarahisar Health Science University
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Contacto:
- Murat Yeşil, Assoc. Prof. Dr.
- Número de teléfono: 905054423142
- Correo electrónico: drmurat17@hotmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Children aged 8 to 14 years.
- Patients requiring diode laser-assisted frenectomy based on clinical indication.
- American Society of Anesthesiologists (ASA) Physical Status I or II.
- Ability of the participant and parent/legal guardian to understand the study procedures.
- Written informed consent obtained from the parent or legal guardian, with assent obtained from the child when appropriate.
Exclusion Criteria:
- Presence of systemic diseases or medical conditions that could influence wound healing or pain perception.
- Current use of analgesic, anti-inflammatory, corticosteroid, or psychotropic medications.
- History of allergy or contraindication to local anesthetic agents.
- Acute oral infection at the surgical site.
- Previous oral soft tissue surgery in the same anatomical region.
- Inability or unwillingness to complete the postoperative pain assessment forms for seven consecutive days.
- Withdrawal of consent at any time during the study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Diode Laser-Assisted Frenectomy
Pediatric patients underwent diode laser-assisted frenectomy according to the standard clinical protocol.
Postoperative pain was assessed once daily for seven consecutive days using validated pediatric pain assessment scales.
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Diode laser-assisted frenectomy was performed under local anesthesia using a standardized surgical protocol by the same experienced pediatric dentist.
Following the procedure, participants received routine postoperative care and were instructed to record postoperative pain once daily for seven consecutive days using the Wong-Baker FACES Pain Rating Scale, the Modified Emoji Pain Scale (MEPS), and gender-specific pain assessment scales.
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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 Intensity Measured by the Wong-Baker FACES Pain Rating Scale
Periodo de tiempo: Daily for 7 consecutive postoperative days
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Postoperative pain intensity assessed using the Wong-Baker FACES Pain Rating Scale.
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Daily for 7 consecutive postoperative days
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Postoperative Pain Intensity Measured by the Wong-Baker FACES Pain Rating Scale
Periodo de tiempo: Daily for 7 days after diode laser-assisted frenectomy
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Postoperative pain intensity was assessed using the Wong-Baker FACES Pain Rating Scale.
Participants recorded their pain level once daily during the first seven postoperative days.
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Daily for 7 days after diode laser-assisted frenectomy
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Özgür Doğan, Assoc. Prof. Dr., Afyonkarahisar Health Science University
Publicaciones y enlaces útiles
Publicaciones Generales
- Armfield JM. Towards a better understanding of dental anxiety and fear: Cognitions vs. experiences. Eur J Oral Sci. 2010;118(3):259-264. Klingberg G, Broberg AG. Dental fear/anxiety and dental behaviour management problems in children and adolescents. Int J Paediatr Dent. 2007;17(6):391-406. Locker D, Liddell A, Shapiro D. Diagnostic categories of dental anxiety: A population-based study. Behav Res Ther. 1999;37(3):301-307. Remi RV, Anantharaj A, Praveen P, et al. Advances in pediatric dentistry: New approaches to pain control and anxiety reduction in children. J Dent Anesth Pain Med. 2023;23(6):303-315. Eymirli PS, Turgut MD. Laser application in pediatric dentistry: A literature update. Ankara Med J. 2019.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
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
- 25.DUS.005.DENIZ
- 25.DUS.005 (Otro número de subvención/financiamiento: Afyonkarahisar Health Science University)
Plan de datos de participantes individuales (IPD)
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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.
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