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- Ensaio Clínico NCT07719270
Management of Postoperative Complications After Mandibular Third Molar Extraction Using Submucosal Triamcinolone Injection, Kinesiology Taping, and Standard Care
Comparative Analysis of Submucosal Triamcinolone Injection and Kinesiology Taping Along With Standard Care, and Standard Care Alone for the Management of Postoperative Complications in Patients After Surgical Mandibular 3rd Molar Extraction
The surgical removal of impacted lower wisdom teeth (mandibular third molars) frequently leads to uncomfortable postoperative symptoms, including pain, facial swelling (edema), and restricted jaw movement (trismus). This study aims to evaluate and compare the effectiveness of two different treatment strategies alongside standard care to reduce these complications.
A total of 60 patients undergoing surgical extraction will be randomly assigned to one of three groups: Group A will receive a local submucosal injection of 10mg Triamcinolone (a corticosteroid), Group B will have Kinesiology Tape applied to the face to enhance fluid drainage, and Group C will receive standard postoperative care alone. Patient recovery outcomes, including pain levels, facial swelling, and jaw mobility, will be monitored and measured at 24 hours, 3 days, and 7 days after the surgery. The study's primary objective is to determine if adding either a pharmacological injection or a mechanical tape significantly improves patient recovery compared to standard postoperative care alone.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Surgical extraction of impacted mandibular third molars inevitably induces soft tissue trauma and bone disruption, triggering an acute inflammatory cascade primarily driven by arachidonic acid metabolites. This trial evaluates a head-to-head comparison between a localized pharmacological agent (corticosteroid) and a non-invasive mechanical intervention (kinesiology taping) to manage post-surgical sequelae.
Triamcinolone Acetonide is a potent synthetic corticosteroid designed to inhibit early-stage inflammatory pathways. Its submucosal administration aims to achieve high local drug concentration at the trauma site while minimizing systemic absorption risks. Conversely, Kinesiology Taping (KT) offers a non-pharmacological approach by microscopically lifting the skin over the masseteric region. This action is intended to reduce interstitial pressure, enhance local microcirculation, and accelerate lymphatic drainage.
This randomized controlled trial evaluates 60 eligible patients divided equally into three arms (n=20 per group):
- Group A: 10 mg Submucosal Triamcinolone combined with standard postoperative care.
- Group B: Face-applied Kinesiology Taping combined with standard postoperative care.
- Group C: Standard postoperative care alone (Control). Clinical outcomes including pain severity, facial swelling, and trismus will be quantified across three distinct postoperative follow-up intervals: 24 hours, 3 days, and 7 days. The gathered data will be analyzed to establish evidence-based guidance on optimizing patient comfort and recovery speed.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Kashaf Tariq, BDS, FCPS OMFS Resident
- Número de telefone: +923326043105
- E-mail: kashaftariq6242@gmail.com
Locais de estudo
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Punjab Province
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Lahore, Punjab Province, Paquistão, 54590
- Allama Iqbal Medical College & Jinnah Hospital
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Contato:
- Kashaf Tariq, BDS, FCPS OMFS Resident
- Número de telefone: +923326043105
- E-mail: kashaftariq6242@gmail.com
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Patients aged 18-40 years
- Surgical patients requiring extraction of Impacted mandibular third molars
Exclusion Criteria:
- Known allergy to corticosteroids/adhesive
- Systemic diseases
- Active infection
- Pregnancy and lactation
- Surgical duration > 45 minutes.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Group A (Triamcinolone + Standard Care)
Patients assigned to receive a single localized submucosal injection of 10mg Triamcinolone Acetonide immediately following surgical extraction of the lower third molar, alongside standard postoperative care.
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Single local submucosal injection of 10mg Triamcinolone Acetonide administered immediately after third molar surgical extraction.
Standard pharmacological regimen (routine oral analgesics/antibiotics) and post-operative home-care instructions.
|
|
Experimental: Group B (Kinesiology Taping + Standard Care)
Patients assigned to receive application of facial Kinesiology Taping (KT) immediately post-surgery to assist with lymphatic drainage, alongside standard postoperative care.
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Standard pharmacological regimen (routine oral analgesics/antibiotics) and post-operative home-care instructions.
Elastic kinesiology tape applied over the masseteric region immediately after surgery to assist in tissue decompression and lymphatic flow.
|
|
Outro: Group C (Standard Care Alone)
Patients assigned to receive standard postoperative pharmacological care alone (such as prescribed oral analgesics and routine post-extraction instructions) with no additional localized intervention.
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Standard pharmacological regimen (routine oral analgesics/antibiotics) and post-operative home-care instructions.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Postoperative Pain Severity
Prazo: Preoperatively (baseline), and at 24 hours, 3 days, and 7 days postoperatively
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Postoperative pain severity will be assessed using a 10-point Visual Analog Scale (VAS), where 0 indicates "no pain" and 10 indicates "the worst pain imaginable
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Preoperatively (baseline), and at 24 hours, 3 days, and 7 days postoperatively
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Postoperative Facial Swelling (Edema)
Prazo: Preoperatively (baseline), and at 24 hours, 3 days, and 7 days postoperatively
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Postoperative facial swelling will be assessed using quantitative facial measurements in millimeters (using standard landmark reference points like tragus to corner of the mouth, tragus to soft tissue pogonion, and lateral canthus to gonion)
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Preoperatively (baseline), and at 24 hours, 3 days, and 7 days postoperatively
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Postoperative Trismus
Prazo: Preoperatively (baseline), and at 24 hours, 3 days, and 7 days postoperatively.
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Postoperative trismus (limited mouth opening) will be quantified in millimeters by measuring the maximum interincisal distance at maximum active mouth opening using a digital vernier caliper
|
Preoperatively (baseline), and at 24 hours, 3 days, and 7 days postoperatively.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Gulraiz Zulfiqar, BDS, FCPS OMFS, CHPE, Allama Iqbal Medical College, Lahore
Publicações e links úteis
Publicações Gerais
- Wilkes MC, Scanlon V, Shibuya A, Cepika AM, Eskin A, Chen Z, Narla A, Glader B, Roncarolo MG, Nelson SF, Sakamoto KM. Downregulation of SATB1 by miRNAs reduces megakaryocyte/erythroid progenitor expansion in preclinical models of Diamond-Blackfan anemia. Exp Hematol. 2022 Jul;111:66-78. doi: 10.1016/j.exphem.2022.04.005. Epub 2022 Apr 20.
- Cavalcante DA, Gadelha A, Noto C. How challenging is to manage agitated patients? Braz J Psychiatry. 2019 Jul-Aug;41(4):277-278. doi: 10.1590/1516-4446-2019-4105. No abstract available.
- Zerener T, Aydintug YS, Sencimen M, Bayar GR, Yazici M, Altug HA, Misir AF, Acikel C. Clinical comparison of submucosal injection of dexamethasone and triamcinolone acetonide on postoperative discomfort after third molar surgery. Quintessence Int. 2015 Apr;46(4):317-26. doi: 10.3290/j.qi.a33281.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
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
- Manifestações Neurológicas
- Doenças do Sistema Nervoso
- Manifestações Neuromusculares
- Espasmo
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Dor
- Trismo
- Edema
- Compostos policíclicos
- Triamcinolona
- Pregada
- Pregnas
- Esteróides
- Compostos de anel fundido
- Esteróides, fluorados
- Acetonido de triancinolona
Outros números de identificação do estudo
- ERB/14/204/AIMC/JHL
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
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