Evaluation of the Clinical and Microbiological Effects of Chlorhexidine Toothpaste on Wound Healing Following Tooth Extraction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Microbiological analysis
研究概览
简要总结
In this study, the postoperative clinical and microbiologic effects of chlorhexidine toothpaste and chlorhexidine-free toothpaste with the same content were compared after bilateral mandibular impacted third molar surgery. Similarly positioned fully impacted impacted lower third molars were extracted. Bilateral impacted wisdom teeth of the patients were randomly selected. After the operation, the experimental group received Dentasave 0.2% chlorhexidine toothpaste containing chlorhexidine and the control group received toothpaste with the same content but without chlorhexidine. Teeth were extracted by the same dentist at 14-day intervals. For microbiological analysis, saliva samples were taken before the first tooth extraction, before the second tooth extraction 14 days later and on the 28th day and sent to the microbiology laboratory. Wound healing, edema and trismus in both extractions were evaluated 1 week after tooth extraction. Wound healing was evaluated as good, acceptable and poor. VAS (Visual Analog Scale) was used for pain assessment and recorded 14 days after tooth extraction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 31 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteers with bilateral fully impacted mandibular wisdom teeth
排除标准
- •Patients were excluded from the study if they did not understand the clinical procedures of the study,
- •Had allergies or intolerance to any of the substances used in the study,
- •Patients on anticoagulant or psychiatric treatment,
- •Pregnant or breastfeeding,
- •Patients using oral contraceptiveswere,
- •Diabetic,
- •Patients with periodontal disease or active infection
- •Smokers of more than 10 cigarettes per day,
- •Poor oral hygiene
结局指标
主要结局
Microbiological analysis
时间窗: 0-28 days
Prior to extraction, a saliva sample was collected from the patient and placed in a sterile 1.5 ml Eppendorf tube and then stored in a -40 oC freezer. After surgical extraction, the patient was given toothpaste with the same content but without chlorhexidine. After a 14-day recovery period, the saliva sample was collected again without extracting the impacted tooth on the contralateral side, and tooth extraction was performed. After the second extraction, the patient was given Dentasave 0.2% Chlorhex toothpaste. The third saliva sample was collected on day 28 (14 days after the second tooth extraction). Saliva samples were stored in sterile universal containers (Eppendorf tubes) and sent to the microbiology laboratory less than 3 hours after collection on days 0, 14, and 28 of the study.
Mouth opening measurements
时间窗: 0-28 days
the distance between the incisals of the patient's central teeth at maximal mouth opening.
Wound healing
时间窗: 0-28 days
View of the wound site in the operation area. The REEDA scale was used for the clinical evaluation of the intraoral surgical field. This scale It includes five factors that indicate wound healing: Redness, Edema, Echymosis, Discharge, Approximation. Each of the recovery factors is evaluated by giving scores of 0, 1, 2 and 3 and the sum of the scores obtained as a result of the evaluation of these five categories constitutes the REEDA score. The lowest score is 0 and the highest score is 15.
Visual Analog Scale
时间窗: 0-28 days
A numerical rating scale VAS was used for pain analysis (0=no pain, 10=most severe pain). The pain levels at 24 hours, 48 hours and 1 week after the surgical procedure were recorded on the patient follow-up form by all patients who participated in the study by explaining that there was no pain at the "zero" level and the most severe pain known at the "10" level on the pain scale, which was organized as a 10 cm horizontal line on the prepared forms.
Facial edema
时间窗: 0-28 days
Measurement between facial craniometric points (angulus-tragus, angulus-lateral canthus, angulus-nasal base, angulus-lateral canthus, and angulus-pogonion). The number of participants in the split mouth model was 22. A total of 44 impacted teeth were extracted and edema was measured before and 1 week after each extraction.
次要结局
未报告次要终点
研究者
Serap Keskin Tunc
Associate Professor Serap Keskin Tunc
Yuzuncu Yıl University