A Comparison of the Effects of Irrigation Solutions at Different Temperatures Used in Oral Surgery on Postoperative Complications and Oral Health-Related Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Postoperative Edema (Swelling)
研究概览
简要总结
The present study aims to compare the effects of saline, chlorhexidine, and hydrogen peroxide irrigation solutions at different temperatures on postoperative complications, including pain, swelling, and mouth opening, as well as oral health-related quality of life, in patients undergoing surgical extraction of impacted mandibular third molars. The irrigation solutions will be applied immediately following surgical tooth extraction at temperatures of either 4°C or 25°C.
An a prior power analysis based on repeated-measures analysis of variance (Repeated Measures ANOVA, within-between interaction) was performed. An effect size of f = 0.25, a Type I error rate (α = 0.05), and a statistical power of 1 - β = 0.95 were assumed.
Based on the power analysis, a minimum of 11 participants per group was determined to be sufficient. Considering potential loss to follow-up and missing data, the sample size was increased by approximately 15%, and it was decided to enroll 13 participants in each group. Accordingly, the planned study will be conducted with a total of 78 participants allocated to six groups, and all participants will be evaluated at four different time points.
详细描述
The removal of mandibular third molars is among the most common procedures carried out in oral surgery. After extraction, patients often experience postoperative complications such as pain, swelling, and limited mouth opening. If these complications become more severe, they can negatively impact the patient's oral health-related quality of life.
In mandibular third molar surgery, following elevation of the soft tissue flap to gain access to the tooth, bone removal is performed using high-speed rotary instruments with continuous irrigation using physiological solutions . Following bone removal and exposure of the tooth, the extraction is performed. Subsequently, irrigation of the extraction socket with physiological saline or antiseptic solutions has been recommended. After socket irrigation and evaluation of the bony structures, the surgical site is sutured and postoperative instructions are provided to the patients.Although the aforementioned studies have demonstrated that socket irrigation may produce favorable postoperative outcomes, to the best of our knowledge, no study has evaluated the effectiveness of irrigation solutions used at different temperatures for socket irrigation.Therefore, the present study aims to compare the effects of saline, chlorhexidine, and hydrogen peroxide irrigation solutions at different temperatures on postoperative complications, including pain, swelling, and mouth opening, as well as oral health-related quality of life, in patients undergoing surgical extraction of impacted mandibular third molars. The irrigation solutions will be applied immediately following surgical tooth extraction at temperatures of either 4°C or 25°C.
The present study aims:
- To evaluate the effectiveness of 0.2% chlorhexidine gluconate and 1.5% hydrogen peroxide irrigation solutions at temperatures of 4°C or 25°C, compared with saline irrigation at the corresponding temperatures, on postoperative complications, including pain, mouth opening, and swelling, following mandibular third molar surgery.
- To evaluate the effectiveness of 0.2% chlorhexidine gluconate and 1.5% hydrogen peroxide irrigation solutions at temperatures of 4°C or 25°C, compared with saline irrigation at the corresponding temperatures, on oral health-related quality of life following mandibular third molar surgery.
Accordingly, the planned study will be conducted with a total of 78 participants allocated to six groups, and all participants will be evaluated at four different time points.
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
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presence of a unilateral or bilateral impacted mandibular third molar classified as Class II, Position B according to the Pell and Gregory classification), indicating that there is insufficient space in the jaw for eruption of the tooth and that the cervical line of the impacted tooth is at the level of the cervical line of the adjacent second molar.
- •Systemically healthy individuals classified as ASA Physical Status I.
- •Age between 18 and 35 years.
- •Willingness to participate in the study.
排除标准
- •Individuals outside the specified age range.
- •Pregnant individuals.
- •Individuals who are currently breastfeeding.
- •Presence of clinical signs of infection in the region of the impacted third molar, including acute pericoronitis.
- •Presence of any systemic disease that may affect wound healing, including metabolic, immunological, or endocrine disorders.
- •Presence of a cystic or tumoral lesion associated with the impacted third molar.
- •History of allergy, hypersensitivity, or intolerance to chlorhexidine gluconate or hydrogen peroxide solutions to be used in the study.
- •Unwillingness to participate in the study.
- •Poor oral hygiene at a level that may adversely affect wound healing.
- •Cold intolerance or the presence or history of cold-related diseases, including Raynaud's disease, cold urticaria, or cryoglobulinemia.
- •Use of systemic antibiotics, corticosteroids, or nonsteroidal anti-inflammatory drugs (NSAIDs) within the previous two weeks.
- •Cases in which no bone removal is required during surgery.
- •Patients who meet the inclusion criteria but are unwilling to participate in the study.
研究组 & 干预措施
4°C 1.5% hydrogen peroxide solution
Patients whose extraction sockets will be irrigated with 4°C 1.5% hydrogen peroxide solution following mandibular third molar surgery.
干预措施: 4°C 1.5% hydrogen peroxide solution (Procedure)
25°C 1.5% hydrogen peroxide solution
Patients whose extraction sockets will be irrigated with 25°C 1.5% hydrogen peroxide solution following mandibular third molar surgery.
干预措施: 25°C 1.5% hydrogen peroxide solution (Procedure)
4°C sterile saline solution
Patients whose extraction sockets will be irrigated with 4°C sterile saline solution following mandibular third molar surgery.
干预措施: 4°C sterile saline solution (Procedure)
25°C sterile saline solution
Patients whose extraction sockets will be irrigated with 25°C sterile saline solution
干预措施: 25°C sterile saline solution (Procedure)
4°C 0.2% chlorhexidine solution
Patients whose extraction sockets will be irrigated with 4°C 0.2% chlorhexidine solution following mandibular third molar surgery.
干预措施: 4°C 0.2% chlorhexidine solution (Procedure)
25°C 0.2% chlorhexidine solution
Patients whose extraction sockets will be irrigated with 25°C 0.2% chlorhexidine solution following mandibular third molar surgery.
干预措施: 25°C 0.2% chlorhexidine solution (Procedure)
结局指标
主要结局
Postoperative Edema (Swelling)
时间窗: Preoperatively and on postoperative days 2, 4, and 7
Edema will be measured along five predetermined anatomical reference lines using a flexible millimeter ruler. Measurements will be recorded in millimeters.
Postoperative Pain
时间窗: Preoperative and postoperative days 2, 4, and 7 using a 10-cm VAS.
Postoperative pain will be assessed by Visual Analog Scale (VAS). The amount of analgesic required by each patient during the postoperative period will be recorded daily on the patient follow-up form.
Trismus (Restriction of Mouth Opening)
时间窗: Preoperative day and postoperative days 2, 4, and 7
Maximum mouth opening will be measured in millimeters using a digital caliper.
次要结局
- Oral Health Related Quality of Life (QoL)(Preoperatively and on postoperative days 2, 4, and 7.)
研究者
Sara SAMUR ERGÜVEN.
Associate Professor
Saglik Bilimleri Universitesi