Effects of 0.2% Hyaluronic Acid Gel-Impregnated Dental Flosses on Clinical Gingival Parameters: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Clinical Periodontal Parameter-Gingival Index (GI)
研究概览
简要总结
This study aimed to evaluate the effects of 0.2% HA-impregnated dental flosses on the clinical periodontal parameters of patients with gingivitis.
详细描述
Gingivitis is a common inflammatory lesion caused by the build-up of oral biofilm and is an essential precursor to periodontitis. For its treatment, oral hygiene habits, such as dental flossing, must be improved, and adjunctive materials, such as hyaluronic acid, may be used to reduce plaque formation and gingival inflammation. This study aimed to assess the effects of 0.2% hyaluronic acid gel (Gengigel®)-impregnated dental flosses on the clinical periodontal markers of patients with gingivitis.
This clinical study adopted a split-mouth, randomized controlled trial design. After clinical data were assessed at baseline, and supragingival scaling and planing was performed, bilateral gingivitis regions were randomly allocated to either a test group (hyaluronic acid gel-impregnated floss) or a control group (regular floss) using a computer-generated randomization table. Clinical parameters were recorded at 1, 2, and 4 weeks after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
盲法说明
The investigator who performed the measurements was blinded to which side of patients was the test group
入排标准
- 年龄范围
- 18 Years 至 47 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18-55 years of age
- •Being systemically healthy
- •Having gingivitis
- •Not to have used any medication in the last three months
- •Not smoking
- •Right-handed
- •At least 20 natural teeth
排除标准
- •Patients with interdental caries
- •Patients with orthodontic appliances
- •Patients with removable (partial) prostheses
- •Patients with oral and/or peri-oral pain
- •Patients with significant oral lesions
- •Patients with antibiotic use in the last 3 months, pregnancy and breastfeeding
- •Patients who have undergone periodontal treatment within the last 6 months
研究组 & 干预措施
Test (HA group)
One side is HA gel impregnated dental floss usage
干预措施: Dental floss+Gengigel (Device)
Control Group
One side is dental floss usage
干预措施: Dental Floss (Device)
结局指标
主要结局
Clinical Periodontal Parameter-Gingival Index (GI)
时间窗: Baseline-4 weeks
Improvement in GI (lower scores mean a better outcome)Minimum score:0 Max.score:3
Clinical Periodontal Parameter-Papillary Bleeding Index (PBI)
时间窗: Baseline-4 weeks
Improvement in PBI (lower scores mean a better outcome)Minimum score:0 Max.score:4
Clinical Periodontal Parameter-Plaque Index(PI)
时间窗: Baseline-4 weeks
Improvement in PI (lower scores mean a better outcome)Minimum score:0 Max.score:5
次要结局
未报告次要终点
研究者
Özlem SARAÇ ATAGÜN
assistant professor
Saglik Bilimleri Universitesi