Effects of Polyvinylpyrrolidone Iodine Concentrations on Postoperative Trismus and Swelling Using as an Irrigation Solution During Impacted Third Molar Surgery : a Randomized Clinical Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 主要终点
- Postoperative Facial Swelling (assessed 3 facial lines (in millimeters) for determination of difference in facial contours before and after surgery)
研究概览
简要总结
The aim of the present study was to evaluate the effects of different concentrations of povidone iodine (PVP-I) on postoperative swelling and trismus when used as a coolant and irrigation solution during the surgical removal of impacted mandibular third molars.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Totally impacted mandibular third molars of class C, 1, 2, and 3 according to the Pell-Gregory classification;
- •Has no systemic disease
排除标准
- •The use of medications that could interfere with the healing process;
- •Pregnancy or lactation;
- •Presence of any condition, such as inflammation, periodontitis, gingivitis and dental abscess in the area of the impacted teeth;
- •Undergoing antibiotic or anti-inflammatory drugs therapies in the 7 days before surgery;
- •History of hypersensitivity to iodine;
- •Has any thyroid diseases.
研究组 & 干预措施
Group I (control; saline only)
Control Group: Intraoperative irrigation with saline solution only.
干预措施: Control (Procedure)
Group II (0.5% concentration of PVP-I )
Experimental Group: Intraoperative irrigation with 0.5% concentration of PVP-I solution.
干预措施: 0.5% concentration of PVP-I (Procedure)
Group III (1% concentration of PVP-I)
Experimental Group: Intraoperative irrigation with 1% concentration of PVP-I solution.
干预措施: 1 % concentration of PVP-I (Procedure)
Group IV (3% concentration of PVP-I)
Experimental Group: Intraoperative irrigation with 3% concentration of PVP-I solution.
干预措施: 3 % concentration of PVP-I (Procedure)
结局指标
主要结局
Postoperative Facial Swelling (assessed 3 facial lines (in millimeters) for determination of difference in facial contours before and after surgery)
时间窗: Preoperative (on the day of surgery)- postoperative 2nd day-postoperative 7th day
For the assessment of facial swelling, three facial lines (in milimeters) were measured with a digital tape on the operated side using following (4) landmarks: the external canthus of the eye, the gonion angle, the lower border of the tragus, soft pogonion and the mouth commissure Facial Lines between: 1. the external canthus of the eye- the gonion angle 2. the lower border of the tragus-the mouth commissure 3. the lower border of the tragus- soft pogonion
Postoperative Trismus (difference in interincisal distance at the maximal mouth opening (in millimeters) before and after surgery)
时间窗: Preoperative (on the day of surgery)- postoperative 2nd day-postoperative 7th day.
The degree of trismus was assessed by measuring the distance between upper and lower incisal borders of the central incisors with a digital caliper.
次要结局
未报告次要终点
研究者
Cansu Gül Koca
Head Of Department, Assistant Professor Doctor
Uşak University