- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Kashaf Tariq, BDS, FCPS OMFS Resident
- Numer telefonu: +923326043105
- E-mail: kashaftariq6242@gmail.com
Lokalizacje studiów
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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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Kontakt:
- Kashaf Tariq, BDS, FCPS OMFS Resident
- Numer telefonu: +923326043105
- E-mail: kashaftariq6242@gmail.com
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.
|
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Eksperymentalny: 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.
|
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Inny: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Postoperative Pain Severity
Ramy czasowe: Preoperatively (baseline), and at 24 hours, 3 days, and 7 days postoperatively
|
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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Postoperative Facial Swelling (Edema)
Ramy czasowe: 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
Ramy czasowe: 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.
|
Współpracownicy i badacze
Sponsor
Śledczy
- Krzesło do nauki: Gulraiz Zulfiqar, BDS, FCPS OMFS, CHPE, Allama Iqbal Medical College, Lahore
Publikacje i pomocne linki
Publikacje ogólne
- 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- ERB/14/204/AIMC/JHL
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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