- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kashaf Tariq, BDS, FCPS OMFS Resident
- Phone Number: +923326043105
- Email: kashaftariq6242@gmail.com
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54590
- Allama Iqbal Medical College & Jinnah Hospital
-
Contact:
- Kashaf Tariq, BDS, FCPS OMFS Resident
- Phone Number: +923326043105
- Email: kashaftariq6242@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
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.
|
|
Other: 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.
|
Standard pharmacological regimen (routine oral analgesics/antibiotics) and post-operative home-care instructions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain Severity
Time Frame: 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
|
Preoperatively (baseline), and at 24 hours, 3 days, and 7 days postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Facial Swelling (Edema)
Time Frame: Preoperatively (baseline), and at 24 hours, 3 days, and 7 days postoperatively
|
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)
|
Preoperatively (baseline), and at 24 hours, 3 days, and 7 days postoperatively
|
|
Postoperative Trismus
Time Frame: Preoperatively (baseline), and at 24 hours, 3 days, and 7 days postoperatively.
|
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.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Gulraiz Zulfiqar, BDS, FCPS OMFS, CHPE, Allama Iqbal Medical College, Lahore
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Neuromuscular Manifestations
- Spasm
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain
- Trismus
- Edema
- Polycyclic Compounds
- Triamcinolone
- Pregnadienes
- Pregnanes
- Steroids
- Fused-Ring Compounds
- Steroids, Fluorinated
- Triamcinolone Acetonide
Other Study ID Numbers
- ERB/14/204/AIMC/JHL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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