Effects of the Preoperative Administration of Dexketoprofen Trometamol on Pain and Swelling After Implant Surgery: a Randomized, Double-blind Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- Acute pain after implant surgery
研究概览
简要总结
The objective of this prospective randomized double-blind study was to evaluate the effects of the preoperative administration of dexketoprofen trometamol (DKT) on the pain perceived by patients after oral surgery for implant placement.
Materials and Method: Single oral doses of 25 mg DKT or PLACEBO were administered 15 minutes before the performance of conventional implant surgery to assess the influence of the DKT on pain as reported by the patients. One hundred patients who required single-implant treatments were randomly distributed into one of the two blinded groups following a preliminary examination. Fifteen minutes before surgery, the patients in the test group were given 25 mg DKT (DKT group), and those in the control group were given 500 mg vitamin C as a placebo (PLACEBO group). The patients' pain intensities were measured using a subjective visual analogue scale of 100 mm in length, and pain was measured over a period of 7 days. Inflammation was assessed using a 5-point Likert scale on days 2 and 7.
详细描述
A total of 100 consecutive patients (November 2013 to October 2015) scheduled for implant surgery in the University Dental Clinic (Murcia, Spain) were included in this study. All patients were older than 18 and were free of medical and surgical contraindications and systemic disease that would conflict with treatment (American Society of Anesthesiologists (ASA) risk I or II). All participants in the study were able to read, understand and respond to the health questionnaire and were able to sign an informed consent document. This study was performed in accordance with the 2014 revision of the Declaration of Helsinki (General Assembly of the World Medical Association, 2014).
Clinical materials The study protocol was approved by the Ethics Committee of the University of Murcia.
The study was conducted with a double blind randomized design using a visual analogue scale (VAS) of 100 mm to measure pain intensity. The degree of inflammation was measured using a 5-point Likert scale (extremely inflamed, very inflamed, inflamed, somewhat inflamed, and not inflamed).
Patients signed two informed consent forms, one for the implant surgery, and the other for participation in the study; the latter explicitly mentioned the patients' ability to leave the study at any time.
A local anaesthetic composed of lidocaine hydrochloride and epinephrine (20 mg/ml + 0.0125 mg/ml, respectively) was applied (never alveolar nerve block).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The patients and the evaluator of the VAS (MMV) were unaware of the results of the randomization and the treatment received.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good systemic health status (ASA I or II).
- •No current pain.
- •No use of painkillers in the prior weeks.
- •Older than 18 years.
- •Oral hygiene index of < 2 (Löe and Silness).
- •A minimum of 2 mm of adhered gum.
- •A minimum of 8 mm of vertical bone.
- •A minimum of 7 mm of vestibule-lingual bone.
- •Scheduled to receive a unitary implant.
- •Willing to participate in this controlled study.
排除标准
- •Pregnant or nursing women.
- •The use of any type of medication that might affect the perception of pain.
- •Level of pain greater than 40 mm on the VAS before surgery.
- •An history of alcohol or drug abuse.
- •Requirement for guided regeneration or maxillary sinus lifting procedures.
- •Failure to comply with the study protocol.
研究组 & 干预措施
DEXKETOPROFEN TROMETAMOL
Patients received a dose of 25 mg DKT in an oral suspension 15 minutes before surgery
干预措施: DEXKETOPROFEN TROMETAMOL (Drug)
Placebo
Patients received a dose of 500 mg Vitamin C in an oral suspension 15 minutes before surgery
干预措施: Placebo (Other)
结局指标
主要结局
Acute pain after implant surgery
时间窗: 2 years (until complete sample)
measured by visual analogue scale (VAS) of 100 mm to measure pain intensity
次要结局
- Inflammation(2 years (until complete sample))
研究者
Arturo Sánchez-Pérez
Associate professor
Universidad de Murcia