Comparison of the Use of Dexamethasone and Diclofenac Sodium in Immediate Post-Operative Care in Third Molar Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Mouth Opening measured by an scale in mm
研究概览
简要总结
The investigators will select 30 patients with symmetrical impaction of third molars, according to Pell and Gregory dental impaction classification, who would be submitted to two surgical procedures, right and left, and in both surgeries dexamethasone 8 mg was administered in the pre-surgery phase, and the use of dexamethasone (12 mg/day) for 3 days on one side and diclofenac sodium (150 mg/day) for 3 days on the other side was continued, in a randomized, double-blind and cross-over trial so that all patients acted as control of themselves (split-mouth). Other drugs used in postoperative period, rescue analgesic and antibiotic therapy will be identical for all patients. The analyzed variables will be the visual analogue pain scale (VAS), total number of consumed analgesics, swelling and trismus (objectively), which were statistically analyzed by means of Student's t-test.
详细描述
STUDY DESIGN
Clinical double-blind, randomized, split-mouth trial. This study was submitted to and approved by the Human Research Ethics Committees of Hospital Geral de Vila Penteado under CAA Protocol: 34824714.8.0000.5446.
MASKING AND RANDOMIZATION
To ensure that the patient, the main researcher, the surgeon and the statistician were unaware of what drug would be used postoperatively, dexamethasone (4 mg) and diclofenac sodium (50 mg) were prepared in capsules of the same color and size, stored in similar vials and coded as drug No. 1 or drug No. 2. The drugs used in different procedures were disclosed only after acquisition and analysis of all data. The randomization procedure will be performed by a researcher not involved in the evaluation of patients and surgeries, using sequentially numbered sealed envelopes. Each envelope had the combination of drugs to be used in the postoperative period, protocol 1 (with 1 drug) or protocol 2 (drug 2) and the side of surgery (right or left). For each enrolled patient, the researcher not involved in patient assessment and surgery opened the envelope, will inform the main researcher of the protocol to be used postoperatively, and the surgeon of the side to be operated. The second surgical procedure was performed on the contralateral side, using another medical protocol postoperatively, with an interval of two months between procedures. Thus, the patient, the surgeon and the main researcher did not know which medical protocol would be used postoperatively.
The methodology of this study sought to follow the rules of the new CONSORT 2010 Statement.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients had to have four third molars indicating the need for extraction and in any position of impact, as long as there was symmetry between the two sides.
排除标准
- •Patients with a history of alcoholism, drug use, antihistamine drugs, antidepressants, cimetidine or any drug that could interfere with the painful sensitivity of the patient.
- •Patients with systemic disorders such as diabetes, hypertension, heart disease, allergy to any component of the formula, sulfa drugs and also pregnant women, nursing mothers, persons experiencing dental fear and children were excluded.
- •Patients who had pericoronitis and/or radiolucent images associated with the teeth to be extracted
研究组 & 干预措施
Dexamethasone
Dexamethasone: Dexametasone 4mg tablet every 8/8hs for 3 days
干预措施: Dexamethasone (Drug)
Diclofenac Sodium
Diclofenac Sodium: Diclofenac Sodium 50 mg tablet every 8/8 hs for 3 days
干预措施: Diclofenac Sodium (Drug)
结局指标
主要结局
Mouth Opening measured by an scale in mm
时间窗: 1 week
Pain assessed with a Visual Analog Scale
时间窗: 1 week
Swelling measured by an scale in mm
时间窗: 1 week
次要结局
未报告次要终点
研究者
Fábio Ricardo Loureiro Sato
Principal Investigator
Hospital Geral de Vila Penteado