Comparison of Efficacy of Serratiopeptidase and Escin After Impacted Mandibular Third Molar Surgery: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Facial Edema
研究概览
简要总结
Justification of the Study There is a high prevalence of impacted third molars, often accompanied by a range of postoperative complications. To the best of the researcher's knowledge, no clinical study to date has directly compared the efficacy of serratiopeptidase and escin in minimizing the most commonly observed postoperative complications following impacted mandibular third molar surgery. This study seeks to address this gap by providing empirical evidence that could contribute to optimizing postoperative care.
Objectives of the Study
Drawing from the background and research questions outlined above, the objectives of this study are divided into general and specific ones, outlined as follows:
General Objective To compare the efficacy of serratiopeptidase and escin, when used as adjuncts to conventional drugs, in reducing postoperative complications (i.e., trismus, facial edema, and pain) following impacted mandibular third molar surgery.
Specific Objectives
The study set the following specific objectives:
- To evaluate the efficacy of serratiopeptidase, as an adjunct to conventional drugs, in reducing postoperative complications (i.e., trismus, facial edema, and pain) following impacted mandibular third molar surgery.
- To evaluate the efficacy of escin, as an adjunct to conventional drugs, in reducing postoperative complications (i.e., trismus, facial edema, and pain) following impacted mandibular third molar surgery.
Study Hypotheses The study formulated the following hypotheses
- Serratiopeptidase, as an adjunct to conventional drugs, provides significantly greater efficacy than conventional drugs alone in reducing postoperative complications (i.e., trismus, facial edema, and pain) following impacted mandibular third molar surgery.
- Escin, as an adjunct to conventional drugs, provides significantly greater efficacy than conventional drugs alone in reducing postoperative complications (i.e., trismus, facial edema, and pain) following impacted mandibular third molar surgery.
- There is a statistically significant difference in the efficacy of serratiopeptidase compared to escin in reducing postoperative complications (i.e., trismus, facial edema, and pain) when both are used as adjuncts to conventional drugs following impacted mandibular third molar surgery.
详细描述
This clinical trial employed a split-mouth design, wherein two different treatments were randomly assigned to opposite halves of each patient's mouth. The study was conducted as a triple-blind randomized trial to minimize bias and enhance scientific rigor. The procedures were carried out by the researcher; however, the operator was blinded to the evaluation data. The evaluator, who had access to patients' symptom responses, remained unaware of which treatment was administered on each side. Likewise, patients were blinded to the treatment or intervention applied to each side of their mouth.
Participants were allocated into two groups, with each patient serving as their own control through the split-mouth approach. On one side, an impacted mandibular third molar was extracted and treated with conventional medications. After a washout period of three weeks, the contralateral molar was extracted and treated with an additional intervention alongside the conventional drugs-either an enzyme or a herbal agent. The groups were defined as follows:
- The first group received conventional medications combined with 10 mg oral serratiopeptidase, administered immediately postoperatively and then thrice daily for five days following the first surgical visit. During the second visit (after three weeks), only conventional drugs were given, or vice versa.
- The second group received conventional medications combined with 20 mg oral escin, administered immediately postoperatively and then thrice daily for five days following the first surgical visit. At the second visit (after three weeks), only conventional drugs were administered, or vice versa.
The conventional medication administered to both groups consisted of Amoxicillin 500 mg capsules twice daily, Metronidazole 500 mg tablets three times daily, and Diclofenac sodium 50 mg tablets twice daily.
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)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medically healthy.
- •Presence of two mandibular third molars indicated for surgical extraction.
- •No history of pericoronitis or other signs of inflammation within the past 30 days.
排除标准
- •Current use of other medications such as NSAIDs or corticosteroids.
- •Known allergy to any drugs administered in this study.
- •Pregnancy or breastfeeding.
- •History of diabetes or hypertension.
- •Previous irradiation to the maxillofacial region.
- •Intellectual disability or inability to attend follow-up visits.
- •Presence of acute or subacute pericoronitis.
研究组 & 干预措施
Serratiopeptidase (Test 1)
This group received conventional medications combined with 10 mg oral serratiopeptidase, administered immediately postoperatively and then thrice daily for five days following the first surgical visit.
干预措施: serratiopeptidase (Drug)
Conventional medication (Control 1)
During the second visit (after three weeks), only conventional drugs were given. It was consisted of Amoxicillin 500 mg capsules twice daily, Metronidazole 500 mg tablets three times daily, and Diclofenac sodium 50 mg tablets twice daily.
干预措施: Conventional drugs (Drug)
Escin (Test 2)
This group received conventional medications combined with 20 mg oral escin, administered immediately postoperatively and then thrice daily for five days following the first surgical visit
干预措施: Escin (Drug)
Conventional medication (Control 2)
During the second visit (after three weeks), only conventional drugs were given. It was consisted of Amoxicillin 500 mg capsules twice daily, Metronidazole 500 mg tablets three times daily, and Diclofenac sodium 50 mg tablets twice daily.
干预措施: Conventional drugs (Drug)
结局指标
主要结局
Facial Edema
时间窗: Baseline measurements were recorded preoperatively. Measurements were reassessed at specific post-operative intervals: immediately after surgery and on the 2nd, 3rd, and 5th postoperative days.
Facial edema was assessed using the method described by Schultze-Mosgau et al. (1995) to quantitatively evaluate edema both before and after surgery. Measurements were taken with a flexible measuring scale while the patient maintained a closed-mouth position. Five fixed anatomical landmarks and three baseline reference lines were used for consistency: • Fixed points: F1 - Tragus of the ear F2 - Angle of the mandible F3 - Soft tissue pogonion F4 - Corner of the mouth F5 - Lateral canthus of the eye • Baseline reference lines: S1 - From tragus of the ear to corner of the mouth (Tr-Com) S2 - From tragus of the ear to soft tissue pogonion (Tr-Pgo) S3 - From lateral canthus of the eye to angle of the mandible (Lc-Gn)
Trismus
时间窗: Baseline measurements were recorded preoperatively. Measurements were reassessed at specific post-operative intervals: immediately after surgery and on the 2nd, 3rd, and 5th postoperative days.
Trismus was evaluated by measuring the change in maximum mouth opening before and after the surgical procedure. Using a calibrated ruler, the distance between the incisal edges of the upper and lower central incisors was measured in millimeters
Pain Intensity
时间窗: Baseline measurements were recorded preoperatively. Measurements were reassessed at specific post-operative intervals: immediately after surgery and on the 2nd, 3rd, and 5th postoperative days.
Pain intensity was evaluated both pre-operatively and post-operatively using a standardized 10-centimeter visual analogue scale (VAS), as described by Sirintawat et al. (2017). The scale ranged from 0, representing no pain, to 10, indicating the worst imaginable pain. At each assessment interval, patients reported the degree of pain they experienced on the scale, providing a simple yet reliable measure of subjective pain.
次要结局
未报告次要终点
研究者
Arwa Mohammed Dahak
Principal Investigator
University of Science and Technology, Yemen