Investigation of the Efficacy of Hypochlorous Acid as a Postoperative Wound Antiseptic: A Randomized Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Plaque index
研究概览
简要总结
The aim was to examine the effectiveness of hypochlorous acid on postoperative wound healing in 24 systemically healthy gingivectomy participants aged 12-30. The participants were divided into 3 groups as hypochlorous acid group, chlorhexidine group and saline group and their wound healing was evaluated on the 1st, 3rd and 7th days.
详细描述
The aim of this study was to investigate the effectiveness of hypochlorous acid on postoperative wound healing in 24 participants aged 12-30 who underwent gingivectomy involving the 6 anterior teeth of the upper or lower jaw with chronic inflammatory gingival overgrowth. The participants were divided into 3 groups as hypochlorous acid group, chlorhexidine group and saline group and were called for control on the 1st, 3rd and 7th days to evaluate wound healing. Periodontal indexes, visual analog scale (VAS), H2O2, plaque staining agent test, and histological analyzes were used to evaluate wound healing. The data were analyzed statistically.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Gingival overgrowth affecting at least six teeth symmetrically in the mandibular or maxillary anterior area
- •No attachment and bone loss
- •7 days before the surgery, full-mouth plaque index (PI) < 25% and a full-mouth gingival bleeding index (GBI) < 25%.
- •the keratinized tissues surrounding the teeth are at least 2 mm wide.
排除标准
- •Smoking or alcohol use
- •Patients who have undergone systemic antimicrobial therapy and surgical procedures within the last 3 months
- •Pregnancy or lactation
- •Immunodeficiency or immunosuppressive drug therapy
研究组 & 干预措施
Hypochlorous Group
In the hypochlorous acid group, 15 ml was used as a postoperative gargle, 2 times * 7 days.
干预措施: Hypochlorous acid (Drug)
Chlorhexidine Group
In the clorhexidine group, 15 ml was used as a postoperative gargle, 2 times * 7 days.
干预措施: Hypochlorous acid (Drug)
Saline Group
In the saline group, 15 ml was used as a postoperative gargle, 2 times * 7 days.
干预措施: Hypochlorous acid (Drug)
结局指标
主要结局
Plaque index
时间窗: Baseline, Day 7
The amount of plaque was scored.
Probing depth
时间窗: Baseline, Day 7
The periodontal pocket depth was performed (mm).
Clinical attachment level
时间窗: Baseline, Day 7
The clinical attachment level was measured (mm).
Gingival index
时间窗: Baseline, Day 7
The gingival status was scored.
Epithelialization with plaque staining agent
时间窗: Day 1, 3, and 7
The wound surface epithelialization was observed with plaque staining agent. The wound surface was stained with plaque staining dye and the dark colored area is calculated as mm2.
Histological analysis
时间窗: Day 1, 3, and 7
Histological analysis evaluated epithelial keratinization, regeneration, and/or degeneration during the healing process and to obtain epithelial samples repeatedly. The number of keratinocytes was counted.
Bleeding on probing
时间窗: Baseline, Day 7
The gingival status was scored.(%)
Epithelialization with H2O2
时间窗: Day 3 and 7
The wound surface epithelialization was observed with H2O2. Scored as foaming present/absent after application with H2O2
postoperative pain with Visiual Analogue Scale (VAS)
时间窗: Day 3 and 7
VAS scores were taken on the 3rd and 7th days without any intervention to the patient. Scored between 1-10 as 1 was no pain, 10 was pain.
次要结局
未报告次要终点
研究者
Sema Nur Sevinc
Principal Investigator
Ataturk University