In Vivo Study for the Evaluation of the Efficacy of an Adjunct Mouthwash in Hygiene, Wound Healing, Analgesia, and Functional Recovery Following Trauma or Dental Procedures in Gingival Tissue
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Healing evaluation
研究概览
简要总结
The goal of this study was to learn if mouthwash works in aiding the healing of the gum tissue after trauma or dental procedure. The main questions it aims to answer are:
- Does mouthwash aid the healing of gum tissue?
- Does mouthwash help to reduce the pain?
- Is the mouthwash well accepted by the volunteers? Researchers will compare mouthwash to a placebo (a look-alike substance that contains no active ingredient) to see if mouthwash works to improve gum tissue healing.
Participants will:
- Use mouthwash or a placebo every day for 15 days
- Visit the dental clinic once a week for evaluations
- Keep a diary of their symptoms
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy patients (ASA I and II),
- •both sexes,
- •over 18 years old
- •undergoing oral surgery (extractions, implants, etc.)
- •wish to participate in the study.
排除标准
- •Patients undergoing healing with Platelet-Rich Plasma (PRP).
- •Allergy or hypersensitivity to any of the product's components.
- •Patients under psychiatric treatment.
- •Pregnant or breastfeeding women.
- •Treatment with NSAIDs, analgesics, or antibiotics for other conditions at the time of starting the study.
- •Treatment with healing antiseptics or oral hygiene products for other oral problems.
- •Treatment with oral anticoagulants.
- •Diabetics.
- •Periodontal disease or an active infectious or acute inflammatory local process at the time of starting the study.
- •Active smoking of more than 10 cigarettes per day.
- •Poor oral hygiene.
- •Any other condition deemed relevant by the specialist.
研究组 & 干预措施
Repairing mouthwash
Repairing mouthwash was used 3 times a day during 15 days after the procedure
干预措施: Repairing mouthwash (Other)
Placebo
Placebo was used 3 times a day during 15 days after the procedure
干预措施: Placebo mouthwash (Other)
结局指标
主要结局
Healing evaluation
时间窗: The parameters were evaluated after the procedure and after 7 and 15 days of product use.
Healing of the oral mucosa after the dental procedure was evaluated by the dentist on a 3 grade Likert scale (0 was good, 1 was acceptable, 2 was bad) taking into account wound edges, oral mucose colour and wound closure. The reduction of the score corresponded to improvement if the wound healing.
次要结局
- Pain intensity evaluation(Pain was evaluated y subjects on a daily basis from procedure until day 7.)