Topical Corticosteroid and Wound Healing After Periodontal Flap Surgery
Effect of Topical Corticosteroid Application on Early Wound Healing After Periodontal Flap Surgery: A Randomized Split-Mouth Clinical Trial
This randomized split-mouth clinical trial aims to evaluate the effect of topical corticosteroid application on postoperative wound healing and pain following periodontal flap surgery in patients with periodontitis. Forty participants requiring bilateral periodontal flap surgery in the maxilla will be included. In each participant, one surgical site will be randomly assigned to receive topical triamcinolone acetonide 0.1% after surgery, while the contralateral site will serve as the control and will receive periodontal flap surgery without topical corticosteroid application. Wound healing, postoperative pain, and periodontal probing depth will be evaluated during the follow-up period.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Periodontitis is a chronic inflammatory disease that may require periodontal flap surgery when adequate treatment outcomes cannot be achieved with non-surgical periodontal therapy alone. Postoperative pain and early wound healing are important factors affecting patient comfort and recovery following periodontal surgery. Topical corticosteroids have anti-inflammatory properties and are widely used for various inflammatory conditions of the oral mucosa; however, evidence regarding their use following periodontal flap surgery is limited.
This prospective, randomized, controlled, split-mouth clinical trial will evaluate the effect of a single topical application of triamcinolone acetonide 0.1% following periodontal flap surgery. Forty patients with periodontitis who require bilateral periodontal flap surgery in the maxilla will be enrolled.
Each participant will undergo periodontal flap surgery at two contralateral maxillary sites in separate surgical sessions. Using random allocation, one site will receive topical triamcinolone acetonide 0.1% following suturing, whereas the contralateral site will undergo the same surgical procedure without topical corticosteroid application and will serve as the control. Thus, each participant will serve as their own control.
Postoperative wound healing and pain will be evaluated during follow-up, together with changes in periodontal probing depth. The split-mouth design is intended to reduce the influence of interindividual variability when comparing the two treatment conditions.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Meral UZUNKAYA, ASSISTANT PROFESSOR
- Número de telefone: +903443003824
- E-mail: meraluzunkaya@ksu.edu.tr
Locais de estudo
-
-
-
Kahramanmaraş, Turquia (Türkiye)
- Recrutamento
- Kahramanmaras Sutcu Imam University, Faculty of Dentistry
-
Contato:
- Meral UZUNKAYA, ASSISTANT PROFESSOR
- Número de telefone: +903443003824
- E-mail: meraluzunkaya@ksu.edu.tr
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Aged 18 years or older Systemically healthy Diagnosed with periodontitis Requiring bilateral periodontal flap surgery in the maxilla Presence of comparable contralateral maxillary surgical sites suitable for a split-mouth design Willing and able to provide written informed consent For female participants, postmenopausal status
Exclusion Criteria:
- Women of childbearing potential Pregnant or lactating women Current smokers Presence of systemic diseases or conditions that may affect periodontal wound healing Use of medications that may affect periodontal tissues or wound healing Inability or unwillingness to comply with the study procedures and scheduled follow-up visits
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Topical Triamcinolone
Participants will undergo open flap debridement (OFD) at the randomly assigned test site in the maxilla. Following completion of the surgical procedure and suturing, 0.1% triamcinolone acetonide will be applied topically to the surgical site as a single application. Each participant will also receive the control intervention at the contralateral maxillary site in a separate surgical session. |
A single topical application of 0.1% triamcinolone acetonide will be administered to the randomly assigned experimental surgical site following completion of open flap debridement and suturing.
Outros nomes:
Open flap debridement (OFD) will be performed at the periodontal surgical site. The surgical procedure will be performed at both the experimental and control sites in separate surgical sessions. |
|
Comparador Ativo: Control
Participants will undergo open flap debridement (OFD) at the contralateral maxillary control site without topical corticosteroid application. Each participant will also receive the experimental intervention at the opposite maxillary site in a separate surgical session. |
Open flap debridement (OFD) will be performed at the periodontal surgical site. The surgical procedure will be performed at both the experimental and control sites in separate surgical sessions. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Early Wound Healing Index (EHI)
Prazo: Postoperative days 7, 14, and 45 after each surgical procedure.
|
Postoperative wound healing will be assessed using the Early Wound Healing Index (EHI) at the surgical sites. The index evaluates early healing of the surgical wound based on clinical characteristics of the incision line. |
Postoperative days 7, 14, and 45 after each surgical procedure.
|
|
Postoperative Pain Assessed by Visual Analog Scale (VAS)
Prazo: Postoperative days 7, 14, and 45 after each surgical procedure.
|
Postoperative pain will be assessed using a Visual Analog Scale (VAS). Participants will rate their pain intensity on a 0-10 scale, where 0 represents no pain and 10 represents the worst imaginable pain. VAS scores will be compared between the topical triamcinolone and control surgical sites. |
Postoperative days 7, 14, and 45 after each surgical procedure.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Periodontal Probing Depth (PPD)
Prazo: Baseline and postoperative day 45 after each surgical procedure.
|
Periodontal probing depth (PPD) will be measured in millimeters using a periodontal probe. Changes in PPD will be evaluated by comparing baseline measurements with postoperative measurements at the surgical sites. |
Baseline and postoperative day 45 after each surgical procedure.
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Dor
- Manifestações Neurológicas
- Doenças Periodontais
- Doenças bucais
- Doenças estomatognáticas
- Complicações pós-operatórias
- Processos Patológicos
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Dor, Pós-operatório
- Periodontite
- Preparações farmacêuticas
- Formas de dose
- Compostos policíclicos
- Triamcinolona
- Pregada
- Pregnas
- Esteróides
- Compostos de anel fundido
- Esteróides, fluorados
- Acetonido de triancinolona
- Pomadas
Outros números de identificação do estudo
- PFK-2026-01
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .