Investigation of the Effects of Chlorhexidine Gluconate + Benzydamine Hydrochloride and Chlorhexidine Gluconate + Flurbiprofen on Pain, Edema, and Trismus Following Mandibular Impacted Third Molar Extraction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Postoperative pain intensity assessed by Visual Analog Scale (VAS)
研究概览
简要总结
This study aims to compare the effects of two commonly used topical mouth sprays on pain, swelling, and limitation of mouth opening after surgical removal of impacted lower wisdom teeth.
A total of 40 adult patients who require the removal of both lower impacted wisdom teeth will participate in this study. Each patient will undergo two separate surgical procedures, with a healing period between them. After each surgery, one of the two topical agents will be applied to the surgical area. The order of the treatments will be randomly assigned.
The study is designed so that neither the patients nor the clinician evaluating the outcomes will know which topical agent is used at each session.
Pain levels, facial swelling, and mouth opening will be measured at specific time points after surgery. The results will help determine whether one topical treatment is more effective than the other in reducing postoperative discomfort and improving recovery.
The information obtained from this study may contribute to improving postoperative care following wisdom tooth surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Monitor Clinician
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged between 18 and 50 years
- •Indication for bilateral impacted mandibular third molar extraction
- •ASA physical status I or II
- •No antibiotic use within the previous two weeks
- •No analgesic use within the previous 12 hours
- •Ability to provide written informed consent
排除标准
- •ASA physical status III to V
- •Pregnancy or breastfeeding
- •Known allergy to chlorhexidine, benzydamine, or flurbiprofen
- •Smoking more than one pack per day
- •History of substance abuse
- •Presence of systemic diseases that may affect wound healing
研究组 & 干预措施
Kloroben Topical Spray Group
Following surgical extraction of the impacted mandibular third molar, Kloroben topical spray containing chlorhexidine gluconate and benzydamine hydrochloride is applied to the surgical site. Patients use the spray postoperatively according to the study protocol, and postoperative pain, swelling, and trismus are evaluated.
干预措施: Klorhex Plus topical spray (Drug)
Klorhex Plus Topical Spray Group
Following surgical extraction of the impacted mandibular third molar, Klorhex Plus topical spray containing chlorhexidine gluconate and flurbiprofen is applied to the surgical site. Patients use the spray postoperatively according to the study protocol, and postoperative pain, swelling, and trismus are evaluated.
干预措施: Kloroben topical spray (Drug)
结局指标
主要结局
Postoperative pain intensity assessed by Visual Analog Scale (VAS)
时间窗: From 30 minutes to 168 hours after surgery
Postoperative pain intensity assessed by the Visual Analog Scale (VAS, 0-10 cm), where 0 indicates no pain and 10 indicates worst imaginable pain; higher scores indicate greater pain intensity.
Postoperative facial swelling measurements
时间窗: Preoperatively, postoperative day 2 and postoperative day 7
Postoperative facial swelling measured by linear facial distances (in centimeters) including tragus to pogonion, tragus to labial commissure, and mandibular angle to lateral canthus; higher values indicate greater swelling.
Maximum mouth opening (trismus assessment)
时间窗: Preoperatively, postoperative day 2 and postoperative day 7
Trismus will be evaluated by measuring the maximum interincisal distance between the upper and lower central incisors using a ruler.
次要结局
- Postoperative analgesic consumption(From the day of surgery to postoperative day 7)
研究者
Edip Eren Kadıkıran
Research Assistant
Marmara University