- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Kashaf Tariq, BDS, FCPS OMFS Resident
- Numero di telefono: +923326043105
- Email: kashaftariq6242@gmail.com
Luoghi di studio
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54590
- Allama Iqbal Medical College & Jinnah Hospital
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Contatto:
- Kashaf Tariq, BDS, FCPS OMFS Resident
- Numero di telefono: +923326043105
- Email: kashaftariq6242@gmail.com
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
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.
|
|
Sperimentale: 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.
|
|
Altro: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Postoperative Pain Severity
Lasso di tempo: 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
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Postoperative Facial Swelling (Edema)
Lasso di tempo: 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
Lasso di tempo: 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
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Preoperatively (baseline), and at 24 hours, 3 days, and 7 days postoperatively.
|
Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: Gulraiz Zulfiqar, BDS, FCPS OMFS, CHPE, Allama Iqbal Medical College, Lahore
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Manifestazioni neurologiche
- Malattie del sistema nervoso
- Manifestazioni neuromuscolari
- Spasmo
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Dolore
- Trisma
- Edema
- Composti policiclici
- Triamcinolone
- Incinta
- In gravidanza
- Steroidi
- Composti anelli fusi
- Steroidi, fluorurati
- Triamcinolone acetonide
Altri numeri di identificazione dello studio
- ERB/14/204/AIMC/JHL
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
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