"Effect of Preoperative Submucosal Dexamethasone on Postoperative Discomfort After Mandibular Third Molar Surgery"

Официальное название

Effect of Preoperative 4 mg Submucosal Dexamethasone on Postoperative Discomfort After Impacted Mandibular Third Molar Surgery: A Randomized Controlled Trial

Обзор

This study aims to determine whether giving a single dose of dexamethasone before surgery can reduce pain and difficulty in opening the mouth after removal of an impacted lower wisdom tooth. Pain and limited mouth opening are common problems after this procedure and can affect eating, speaking, and daily activities. A total of 268 patients aged 18 to 55 years who require surgical removal of an impacted mandibular third molar will be included. Participants will be randomly assigned to one of two groups. One group will receive a 4 mg dexamethasone injection under the gum before surgery, while the other group will not receive this medication. All patients will undergo the same surgical procedure and receive standard postoperative care. Pain will be measured using a visual analogue scale, and mouth opening will be assessed using a standard measuring method. These outcomes will be recorded on the second and seventh days after surgery. The results of this study will help determine whether preoperative dexamethasone is an effective and simple method to reduce postoperative discomfort and improve recovery after third molar surgery.

Подробное описание

This randomized controlled trial is designed to evaluate the efficacy of a single preoperative 4 mg submucosal dexamethasone injection in reducing postoperative discomfort following surgical removal of impacted mandibular third molars. Postoperative discomfort is defined by two primary components: pain intensity and degree of trismus.

The study will be conducted at the Department of Oral and Maxillofacial Surgery, MTI-Hayatabad Medical Complex, Peshawar, Pakistan. A total of 268 participants aged 18-55 years requiring surgical extraction of impacted mandibular third molars will be enrolled using non-probability consecutive sampling. Participants with systemic disease, pregnancy, lactation, recent use of antibiotics or anti-inflammatory drugs, or periodontal disease will be excluded.

Eligible participants will be randomly allocated into two equal groups (n=134 each) using a computer-generated randomization method. The intervention group will receive a single 4 mg submucosal injection of dexamethasone at the surgical site following administration of local anesthesia. The control group will undergo the same surgical procedure without administration of dexamethasone.

All procedures will be standardized, including surgical technique (Ward's incision, bone removal, and suturing) and postoperative analgesia (diclofenac 50 mg). No blinding will be performed due to the nature of the intervention.

Pain intensity will be assessed using a 10-cm visual analogue scale (VAS), while trismus will be evaluated by measuring maximum inter-incisal distance (in millimeters) using a vernier caliper. Measurements will be recorded preoperatively and on postoperative days 2 and 7.

Data will be analyzed using SPSS. Continuous variables will be assessed for normality using the Shapiro-Wilk test and expressed as mean ± standard deviation. Between-group comparisons will be performed using independent samples t-test or Mann-Whitney U test, as appropriate. Categorical variables will be expressed as frequencies and percentages and analyzed using chi-square or Fisher's exact test. A p-value ≤0.05 will be considered statistically significant.

This study is expected to provide evidence on the effectiveness of submucosal dexamethasone as a simple, cost-effective intervention to reduce postoperative morbidity following third molar surgery.

Вмешательства

• Препарат Dexamethasone
  A single 4 mg dose of dexamethasone is administered via submucosal injection at the surgical site following local anesthesia prior to extraction of the impacted mandibular third molar.
• Другое No intervention
  Participants do not receive dexamethasone or any study drug. Standard surgical extraction of impacted mandibular third molars is performed, followed by routine postoperative care including analgesia.

Первичные конечные точки

• Postoperative Pain Assessed by Visual Analogue Scale (VAS) [Срок оценки: Postoperative Days 2 and 7]

Критерии участия

Критерии включения

• Adults aged 18 to 55 years
• Patients requiring surgical extraction of impacted mandibular third molars
• Patients willing to provide informed consent

Критерии исключения

• Patients with systemic diseases
• Patients with periodontal disease
• Pregnant or lactating women
• Patients who have used antibiotics or anti-inflammatory drugs within the past 7 days
• Patients with known hypersensitivity to dexamethasone

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Gaballah K, Eldohaji T, Tannir ME, Shaban R, Habib R, Ali K. Pain control following impacted mandibular third molar surgery: a comparison of the effectiveness of two different protocols. Sci Rep. 2025 Apr 3;15(1):11519. doi: 10.1038/s41598-025-89744-0. PMID 40181005
• Selvido DI, Bhattarai BP, Niyomtham N, Riddhabhaya A, Vongsawan K, Pairuchvej V, Wongsirichat N. Review of dexamethasone administration for management of complications in postoperative third molar surgery. J Korean Assoc Oral Maxillofac Surg. 2021 Oct 31;47(5):341-350. doi: 10.5125/jkaoms.2021.47.5.341. PMID 34713808
• Hou C, Liu F, Liu C. Comparison of Submucosal With Intramuscular or Intravenous Administration of Dexamethasone for Third Molar Surgeries: A Systematic Review and Meta-Analysis. Front Surg. 2021 Aug 10;8:714950. doi: 10.3389/fsurg.2021.714950. eCollection 2021. PMID 34447785
• 3. Gojayeva N, Pashtayeva N, Nagiyev N, Aliyev A, Özmeriç N, Gülşahı A, et al. Comparison of postoperative pain, swelling, and trismus after impacted mandibular third molar extraction using different cold applications: a randomized controlled clinical trial. BMC Oral Health. 2024;24:131. doi:10.1186/s12903-024-03877-8
• Rizqiawan A, Lesmaya YD, Rasyida AZ, Amir MS, Ono S, Kamadjaja DB. Postoperative Complications of Impacted Mandibular Third Molar Extraction Related to Patient's Age and Surgical Difficulty Level: A Cross-Sectional Retrospective Study. Int J Dent. 2022 Jan 3;2022:7239339. doi: 10.1155/2022/7239339. eCollection 2022. PMID 35027927
• Synan W, Stein K. Management of Impacted Third Molars. Oral Maxillofac Surg Clin North Am. 2020 Nov;32(4):519-559. doi: 10.1016/j.coms.2020.07.002. Epub 2020 Sep 9. PMID 32919832

Идентификаторы

NCT: NCT07554963 · HMC-OMFS-DEXA-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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