Management of Postoperative Complications After Mandibular Third Molar Extraction Using Submucosal Triamcinolone Injection, Kinesiology Taping, and Standard Care

Official title

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

Overview

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.

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):

1. Group A: 10 mg Submucosal Triamcinolone combined with standard postoperative care. 2. Group B: Face-applied Kinesiology Taping combined with standard postoperative care. 3. 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.

Interventions

• Drug Triamcinolone Acetonide 10mg
  Single local submucosal injection of 10mg Triamcinolone Acetonide administered immediately after third molar surgical extraction.
• Device Kinesiology Taping
  Elastic kinesiology tape applied over the masseteric region immediately after surgery to assist in tissue decompression and lymphatic flow.
• Other Standard Postoperative Care
  Standard pharmacological regimen (routine oral analgesics/antibiotics) and post-operative home-care instructions.

Primary outcome measures

• Postoperative Pain Severity [Time frame: Preoperatively (baseline), and at 24 hours, 3 days, and 7 days postoperatively]

Secondary outcome measures (2)

• Postoperative Facial Swelling (Edema) [Time frame: 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Pakistan · 1 center

• Allama Iqbal Medical College & Jinnah Hospital — Lahore

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. PMID 35460833
• 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. PMID 31365715
• 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. PMID 25529005

Identifiers

NCT: NCT07719270 · ERB/14/204/AIMC/JHL

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗