Randomized Clinical Trial of Microbial Growth in the Suture Thread, After the Post-surgical Application of Different Antiseptic Gels in Mandibular Third Molars Extraction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 21
- 主要终点
- Postoperative pain in the operated area.
研究概览
简要总结
This is a randomized clinical trial in which investigators will compare the antimicrobial effect and inducer of cicatrization as well as the degree of postoperative pain in patients who are extracted the lower third molars.
After the surgery, different bioadhesive gels will be applied in the area of the surgical wound and we will evaluate the aforementioned parameters.
详细描述
Introduction
Surgical removal of the third molars is one of the most frequent procedures in oral surgery. Healing of the wound is initially sought by approximating the edges using a suturing technique. Adherence and microbiological accumulation of the suture during the period that it remains in the mouth, which can serve as a focus for odontogenic infections. The use of oral antiseptics before and after the surgery is an efficient method for microbial reduction. The purposes of this project were to evaluate the microbial growth in the suture thread on different culture means after the post-surgical application of the gels under study, while assessing the intensity of post-surgical pain and the degree of healing of the surgical wound.
Material and methods
It is a randomized and blind clinical trial. 21 patients participated (42 wisdom teeth), who consulted the unit for a surgical tooth extraction for at least the two lower wisdom teeth. The evaluated bioadhesive gels were: Chlorhexidine gel at 0.2 % (Bexident Gel Gingival®), Chlorhexidine gel at 0.2% + Chitosan (Bexident Post®) and hyaluronic acid gel (ODDENT®). A neutral water-based gel without any active ingredients was also used HISPAGEL 200® (Acofarma, Madrid, Spain) as the control agent. An assessment of the post-surgical healing, the microbiological analysis of the suture thread and the post-surgical pain was developed.
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 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: between 18 and 39 years.
- •Good general health.
- •Availability during the study.
- •No current odontological treatments or foreseen during the study period.
- •Acceptance and compliance with the prescribed oral hygiene instructions.
- •Agreement to not used mouthwashes or toothpastes with antiseptic agents during the study period.
排除标准
- •Use of antimicrobial mouthwashes or toothpastes during the period during which the suture remains in the mouth.
- •Diabetes.
- •Degenerative diseases.
- •Deficient oral health (cavities, periodontal disease, pathologies of the oral mucosa...).
- •Wearing prosthetic or orthodontic devices.
- •Amoxicillin allergy.
- •Pregnant or lactating women.
研究组 & 干预措施
Placebo gel
The placebo gel is used by all patients on one side of the mouth and serves as a control group.
干预措施: Placebo gel (Drug)
Placebo gel
The placebo gel is used by all patients on one side of the mouth and serves as a control group.
干预措施: Clorhexidine gel (Drug)
Placebo gel
The placebo gel is used by all patients on one side of the mouth and serves as a control group.
干预措施: Clorhexidine-Chitosan gel (Drug)
Placebo gel
The placebo gel is used by all patients on one side of the mouth and serves as a control group.
干预措施: Hyaluronic Acid gel (Drug)
Clorhexidine gel
Chlorhexidine gel is one of three gels used to compare the placebo gel and will be used on the contralateral side to the side assigned as placebo in a third of the participants.
干预措施: Placebo gel (Drug)
Clorhexidine gel
Chlorhexidine gel is one of three gels used to compare the placebo gel and will be used on the contralateral side to the side assigned as placebo in a third of the participants.
干预措施: Clorhexidine gel (Drug)
Clorhexidine gel
Chlorhexidine gel is one of three gels used to compare the placebo gel and will be used on the contralateral side to the side assigned as placebo in a third of the participants.
干预措施: Clorhexidine-Chitosan gel (Drug)
Clorhexidine gel
Chlorhexidine gel is one of three gels used to compare the placebo gel and will be used on the contralateral side to the side assigned as placebo in a third of the participants.
干预措施: Hyaluronic Acid gel (Drug)
Clorhexidine-Chitosan gel
Clorhexidine-chitosan gel is one of three gels used to compare the placebo gel and will be used on the contralateral side to the side assigned as placebo in a third of the participants.
干预措施: Placebo gel (Drug)
Clorhexidine-Chitosan gel
Clorhexidine-chitosan gel is one of three gels used to compare the placebo gel and will be used on the contralateral side to the side assigned as placebo in a third of the participants.
干预措施: Clorhexidine gel (Drug)
Clorhexidine-Chitosan gel
Clorhexidine-chitosan gel is one of three gels used to compare the placebo gel and will be used on the contralateral side to the side assigned as placebo in a third of the participants.
干预措施: Clorhexidine-Chitosan gel (Drug)
Clorhexidine-Chitosan gel
Clorhexidine-chitosan gel is one of three gels used to compare the placebo gel and will be used on the contralateral side to the side assigned as placebo in a third of the participants.
干预措施: Hyaluronic Acid gel (Drug)
Hyaluronic acid gel
Hialuronic acid gel is one of three gels used to compare the placebo gel and will be used on the contralateral side to the side assigned as placebo in a third of the participants.
干预措施: Placebo gel (Drug)
Hyaluronic acid gel
Hialuronic acid gel is one of three gels used to compare the placebo gel and will be used on the contralateral side to the side assigned as placebo in a third of the participants.
干预措施: Clorhexidine gel (Drug)
Hyaluronic acid gel
Hialuronic acid gel is one of three gels used to compare the placebo gel and will be used on the contralateral side to the side assigned as placebo in a third of the participants.
干预措施: Clorhexidine-Chitosan gel (Drug)
Hyaluronic acid gel
Hialuronic acid gel is one of three gels used to compare the placebo gel and will be used on the contralateral side to the side assigned as placebo in a third of the participants.
干预措施: Hyaluronic Acid gel (Drug)
结局指标
主要结局
Postoperative pain in the operated area.
时间窗: Seven days.
The researchers will analyze the degree of postoperative pain patients suffered during the first postoperative week by applying one of the gels to be studied in the area of the surgical wound. To make this measurement the visual analogue pain scale will be used.
Microbiological growth on suture tread.
时间窗: Seven days.
Microbiological growth in CFUs on the suture thread after the application of the distinct bioadhesive gels.
Degree of healing.
时间窗: Seven days.
The degree of healing at 7 days after surgery was measured using a visual healing scale consisting of four different levels of healing status: 1. - Erithymatous surgical zone and with signs of inflammation and infection. 2. - Erythematous surgical site without signs of infection. 3. -Surgical zone of normal color and beginning of epithelization. 4. -Surgical zone of normal color and advanced epithelization.
次要结局
未报告次要终点
研究者
Samuel Rodríguez Zorrilla
DDS, MSc.
University of Santiago de Compostela