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临床试验/NCT04373421
NCT04373421已完成4 期

Effect of St. John's Wort Oil and Olive Oil on the Postoperative Complications After Impacted Third Molar Surgery: Randomized, Double-blind Clinical Trial

Yuzuncu Yıl University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年8月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
Postoperative Pain

研究概览

简要总结

Surgical removal of impacted third molars is one of the most frequent procedures carried out in the oral and maxillofacial surgery clinics. There are a varying range of postoperative complications including pain, edema and swelling. Antibiotics, analgesics and mouthwashes are usually prescribed for the treatment of these complications. Patients undergoing impacted third molar surgery are frequently prescribed chlorhexidine mouthwashes with/without benzydamine hydrochloride. However, to preclude the adverse effects of these chemical agents, there has been a search for plant-derived alternatives with anti-inflammatory, antibacterial and analgesic properties as part of the oral care routine following surgical removal of impacted third molars. However, there is no study investigating the comparison of different essential oils in the literature. Thus, this multicenter study was aimed to evaluate the effects of St. John's wort oil and virgin olive oil on the postoperative complications and compared with chlorhexidine gluconate plus benzydamine hydrochloride mouthwash after the removal of impacted wisdom teeth.This study was aimed to evaluate the effects of St. John's wort oil, virgin olive oil, and chlorhexidine gluconate plus benzydamine hydrochloride on the postoperative complications after the removal of impacted wisdom teeth.

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

入选标准

  • be 18-40 years old
  • has unilateral mandibular impacted third molars with similar angulation position according to Winter's classification (mesio-angular) and similar impaction degree according to Pell & Gregory's classification (class II, Level B).
  • absence of any systemic disease
  • absence of pregnancy/lactating state,

排除标准

  • Patients with smoking habits, drug abuse, history of pericoronitis associated with the lower third molar
  • not regularly coming to the controls

研究组 & 干预措施

chlorhexidine gluconate plus benzydamine hydrochloride

Active Comparator

Chlorhexidine is one of the most commonly used medications after tooth extraction. It exhibits a wide spectrum of antiseptic, bactericidal and bacteriostatic effects. The most common side effect of chlorhexidine is oral discoloration, taste changes and allergic responses. Furthermore, it has been reported that chlorhexidine has cytotoxic effect on gingival fibroblasts, epithelial cells, neutrophils and red blood cells; also shows incremental trend in genotoxicity as the duration of usage is increased. Benzydamine hydrochloride is a nonsteroidal anti-inflammatory drug that elicits anti-inflammatory, analgesic, anesthetic and antimicrobial effects. It is often used in addition to the topical application of chlorhexidine.. However, side effects such as urticaria, erythema, pruritus, photosensitivity, bronchospasm and renal problems can be observed associated with the use of benzydamine.

干预措施: Chlorhexidine Gluconate 0.12 % Mouthwash + benzydamine hydrochloride (Drug)

St. John's wort oil

Active Comparator

St. John's Wort (Hypericum perforatum) is a European medicinal plant with a history of more than 2000 years which possessing a variety of important constituents including phloroglucinols (hyperforin and adhyperforin), naphthodianthrones (hypericin and pseudohypericin), xanthones, essential oil, biflavones (biapigenin and amentoflavone), flavonol derivatives and phenolic compounds. The important components of St. John's Wort such as hypericin and hyperforin exert anti-inflammatory, antimicrobial, anticancer effects as well as stimulating tissue growth and differentiation. Hypericin exhibits anti-inflammatory effects by inhibiting the production of interleukin-12; whereas hyperforin reveals this effect by inhibiting the mechanisms of cyclooxygenase 1, 5-lipoxygenase and prostaglandin E2. St. John's Wort oil is extracted by maceration of the hypericum herb in carrier oil, such as virgin olive oil.

干预措施: St. John's wort oil (Procedure)

Virgin olive oil

Active Comparator

The olive oil, a product extracted from the fruit of Olea europaea, exerts also antioxidant and anti-inflammatory effects due to its important contents including oleic acids, phenolic acids, secoiridoids and flavonoids. The oral application of olive oil has been shown to have protective anti-inflammatory effects and accelerated epithelial healing.

干预措施: Virgin olive oil (Procedure)

结局指标

主要结局

Postoperative Pain

时间窗: Postoperatif 7th day

To record the level of pain, patients were instructed to rate it on a 100-mm visual analog scales (VAS) was used wherein 0 indicated no pain and 100 indicated the worst pain imaginable.

Postoperative Jaw Function

时间窗: Postoperatif 7th day

For the assessment of difficulty during jaw function, patients were asked to rate it on a 100-mm VAS, wherein 0 indicated no limitation and 100 indicated severe limitation.

Postoperative Swelling

时间窗: Postoperative 7th day

Facial swelling was assessed using a thread and millimeter ruler and averaged the following five measurements: Distance I (from the angle of the mandible to labial commissure); Distance II (from the angle of the mandible to the nasal border); Distance III (from the angle of the mandible to the external corner of the eye); Distance IV (from the angle of the mandible to tragus) and Distance V (from the angle of the mandible to soft pogonion). For evaluation of changes in the abovementioned distances during the postoperative period, the percentage of facial swelling was calculated by subtracting the preoperative measurements from the postoperative measurements then divided by the preoperative measurements and multiplied by 100.

Postoperative Trismus

时间窗: Postoperative 7th day

For evaluation of trismus, the percentage of difference in maximum mouth opening during the postoperative period (B) was calculated by subtracting the preoperative measurement (A) from the postoperative measurement then dividing by the preoperative measurement (A) and multiplying by 100 (percentage of difference = \[B - A\]/B × 100).

次要结局

未报告次要终点

研究者

发起方
Yuzuncu Yıl University
申办方类型
Other
责任方
Principal Investigator
主要研究者

levent Cigerim

Head of Oral and Maxillofacial Surgery Department

Yuzuncu Yıl University

研究点 (1)

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