The Effect of Chlorhexidine (0.5%) With Combination of Hyaluronic Acid on Postoperative Wound Healing After Lower Third Molar Removal: a Placebo Controlled Triple Blind Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Wound healing
研究概览
简要总结
Our aim is to evaluate chlorhexidine-hyaluronic acid containing gel on postoperative wound healing regarding impacted lower third molar surgery.
详细描述
This is a triple-blind, placebo-controlled randomized clinical trial. Sixty patients will be randomly assigned to two treatment groups: Arm 1 receives Curasept DNA ADS periodontal gel during impacted third molar removal, while Arm 2 receives a placebo gel. Patient allocation uses an electronic randomization system with a 1:1 ratio. Baseline characteristics are recorded at the first clinical visit. The surgical procedure includes local anesthesia, mucoperiosteal flap elevation, bone removal with a surgical handpiece, and wound closure with non-resorbable sutures. Test gel or placebo is applied post-tooth removal, and patients are monitored postoperatively for pain, swelling, and wound healing, including follow-ups on the third, seventh and fourteenth days. Data analysis will use descriptive and statistical methods to evaluate efficacy.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients having lower impacted third molar
- •impaction pattern Pell-Gregory II/A, III/A, I/B, II/B, III/B that means partially impacted, partially erupted teeth, where primary wound closure is usually not possible;
排除标准
- •systemic disease (diabetes, steroids, antiresorptive therapy);
- •allergy on gel's compounds;
- •pregnancy;
- •active or subacute local infection at third molar tooth (pericoronitis);
- •poor oral hygiene (based on the presence of active caries and/or plaque index of 2-3)
研究组 & 干预措施
Curasept DNA ADS periodontal gel
干预措施: Third molar surgery (Procedure)
Placebo gel wound dressing
干预措施: Third molar surgery (Procedure)
结局指标
主要结局
Wound healing
时间窗: From enrollment to the end of treatment at 2 weeks
Scoring wound healing according to Inflammatory Proliferative Remodelling (IPR) Wound Healing Scale: 0-16: the smaller number indicates the poorer outcome
次要结局
- Mouth opening(From enrollment to the end of treatment at 2 weeks)
- Subjective pain level(From enrollment to the end of treatment at 2 weeks)
- Face swelling(From enrollment to the end of treatment at 2 weeks)
- Taken analgesics (questionaire)(From enrollment to the end of treatment at 2 weeks)
研究者
Balazs Soos
Participating investigator
University of Pecs