The Effect of Topical Application of Manuka Honey on Healing After Extraction of Impacted Lower Third Molars: A Split-Mouth Design Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- The presence or absence of alveolar osteitis
研究概览
简要总结
Since there is an evidence that Manuka honey is an antibacterial agent, the present study aims to confirm this characteristic and assess its effect in improving healing and reducing postsurgical symptoms, if topically applied after the surgical removal of impacted mandibular third molars
详细描述
Sufficient evidence exists recommending the use of honey in the management of acute wounds and burns. Studies revealed that the healing effect of honey could be classified by its antibacterial, antiviral, anti-inflammatory and antioxidant properties of its components. Manuka honey has been shown to inhibit a wide range of microorganisms, including multiresistant strains. This unique honey is derived from flowers of manuka tree (Leptospermum scoparium) in New Zealand. Dihydroxyacetone and methylglyoxal are unique and naturally occurring constituents of manuka honey that correlate with its antibacterial activity.
Since surgical extraction of impacted molars is one of the most common operations in the oral cavity and the postoperative symptoms disturbing the patient may reduce the quality of health service, this study aims to assess the healing potential of Manuka honey in reducing these symptoms by comparing the outcome of extraction of impacted lower molars with and without topical application of Manuka honey into the extraction socket.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 37 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Asymptomatic, Symmetrical, Bilateral Impacted Third Molars
排除标准
- •Uncontrolled diabetes,
- •Hypersensitivity to Honey
- •Alcoholism,
- •Drug abuse,
- •Pathological condition in the region
结局指标
主要结局
The presence or absence of alveolar osteitis
时间窗: This will be assessed on the 3rd and 7th day following surgery
The presence of a dry socket condition will be checked out at two time points.
Change of the masticatory muscles status
时间窗: Measurements will be taken before surgery, on the 3rd and on the 7th days after surgery.
Mouth opening range will be assessed by measuring the distance between the upper and lower incisors using a vernier caliper when the patient is asked to open his/her mouth as much as possible. The presence of limited opening of the mouth is an indication of trismus.
Levels of postoperative discomfort
时间窗: 7 days after the surgical removal of third molars
Postoperative Symptom Severity (PoSSe) Scale will be used for this variable. The patient will be asked to fill in a questionnaire on the 7th day following surgery. This questionnaire is used to assess postoperative discomfort in patients who have third molars extracted. PoSSe Scale consists of 7 sub-scales that investigate the patient's ability to enjoy food; speak properly; perceive altered sensations, appearance, pain, and sickness; and interference with daily activities.
Pain and Change of pain
时间窗: This will be assessed on the 3rd and 7th day following surgery
using a Visual Analog Scale of Faces (VASoF).
Change of facial contours due to swelling
时间窗: Measurements will be taken before surgery, on the 3rd and on the 7th days after surgery.
In order to assess facial swelling, the distances between the labial commissure and the tragus, and between the lateral canthus and the gonion will be measured. The change between 3 days and before surgery will give an idea about the amount of swelling that occurred following surgery. Between 3 days and 7 days will give an idea about the change that occurred in this period.
次要结局
- Time required to hemostasis(This will be recorded by the patient in the immediate postsurgical phase (i.e. between 10 minutes up to 72 hours following surgery))
- Bone density and quality(at six months following surgery)
- Change of bone healing status(at 3 and six months following surgery)