Efficacy of Preoperative Long-acting Corticosteroids on Postoperative Pain, Swelling, and Trismus Following Impacted Mandibular Third Molar Surgery: A Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Postoperative pain
研究概览
简要总结
This study evaluated whether giving a single dose of long-acting corticosteroids before wisdom tooth surgery reduces pain, facial swelling, and limited jaw opening (trismus) after surgery. Adult patients aged 18-35 undergoing impacted lower wisdom tooth removal were randomly assigned to receive either 8 mg dexamethasone or a placebo before surgery. Pain, swelling, and jaw mobility were measured at several time points after surgery. The study aimed to determine if preoperative corticosteroids improve recovery and reduce discomfort following surgery.
详细描述
Surgical removal of impacted lower wisdom teeth often causes pain, swelling, and reduced jaw opening (trismus) due to tissue inflammation. This study examined whether giving a single dose of long-acting corticosteroids before surgery could reduce these postoperative problems.
Adult patients aged 18-35 years who required surgical extraction of impacted mandibular third molars were randomly assigned to receive either 8 mg dexamethasone (treatment group) or a placebo (control group) 30 minutes before surgery. The study measured pain using a visual analog scale, facial swelling with standard facial landmarks, and jaw opening with calipers at multiple time points after surgery. Analgesic consumption was also recorded.
The goal was to determine whether preoperative corticosteroid administration could improve recovery, reduce discomfort, and enhance patient comfort after third molar surgery. This information may help guide oral surgeons in postoperative care and improve outcomes for patients undergoing similar procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, care providers, investigators, and outcome assessors were blinded to group allocation. Identical syringes were prepared by an independent clinician not involved in treatment or outcome assessment.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18-35 years
- •Indicated for surgical removal of impacted mandibular third molars (Pell & Gregory Class II-III)
- •ASA I or II (healthy or mild systemic disease)
- •Willing to provide informed consent
排除标准
- •Known allergy to corticosteroids
- •Systemic diseases contraindicating steroid use (e.g., uncontrolled diabetes, immunosuppression)
- •Pregnancy or lactation
- •Acute pericoronitis or local infection
- •Current use of steroids or NSAIDs
研究组 & 干预措施
Dexamethasone Group (Treatment)
Participants receive a single dose of 8 mg dexamethasone administered intramuscularly 30 minutes before impacted mandibular third molar surgery. This intervention is intended to reduce postoperative pain, facial swelling, and limited jaw opening (trismus). Participants, care providers, investigators, and outcome assessors are blinded to group allocation.
干预措施: Dexamethasone 8 mg IM (Drug)
Placebo Group (Control)
Participants receive a single dose of normal saline (placebo) administered intramuscularly 30 minutes before impacted mandibular third molar surgery. This arm serves as the control group for comparison with the dexamethasone group. Blinding is maintained for participants, care providers, investigators, and outcome assessors.
干预措施: Normal Saline IM (Drug)
结局指标
主要结局
Postoperative pain
时间窗: 6, 24, 48, and 72 hours postoperatively.
Postoperative pain will be assessed using the Visual Analog Scale (VAS), a 10-cm horizontal line ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain intensity.
Facial Swelling Measured by Linear Facial Measurements (Tragus-Pogonion and Gonion-Lateral Canthus Distances)
时间窗: Preoperatively, Day 2, and Day 7 postoperatively
Facial swelling will be assessed using standardized linear facial measurements between anatomical landmarks (tragus to pogonion and gonion to lateral canthus) using a flexible measuring tape. Measurements will be recorded in millimeters (mm). An increase in distance compared to preoperative values indicates greater facial swelling.
Trismus (Maximum interincisal opening)
时间窗: Preoperatively, Day 2, and Day 7 postoperatively
Trismus will be measured by maximum interincisal mouth opening using calipers.
次要结局
- Analgesic consumption(Postoperative days 1-7)
- Number of rescue analgesic tablets taken(Postoperative days 1-7)