Evaluation of the Effects of Using an Interdental Brush Dipped in 0.2% Hyaluronic Acid Gel on Clinical Periodontal Parameters Among Patients With Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Plaque index (PI)
研究概览
简要总结
This study aimed to compare the effects of using an interdental brush dipped in 0.2% HA gel with those of using a regular interdental brush on clinical periodontal parameters following SRP among patients with periodontitis.
详细描述
The additional use of agents with antibacterial and anti-inflammatory activities such as hyaluronic acid (HA) in treating periodontal disease has recently become popular. This study aimed to evaluate the effects of using an interdental brush dipped in 0.2% HA gel on clinical periodontal parameters.This randomized controlled trial was conducted among 33 female patients and 27 male patients with stage II/III grade A/B periodontitis. After the initial periodontal treatment, patients were randomly divided into two groups; those in the test group were asked to use an interdental brush dipped in 0.2% HA gel twice a day after brushing, while those in the control group were asked to use a regular interdental brush. Clinical periodontal parameters including the pocket depth, clinical attachment loss, gingival index, plaque index, and papillary bleeding index (PBI) were assessed at baseline and in the 1st and 3rd months after treatment.
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
- Single (Investigator)
盲法说明
The investigator carrying out the measurements was not aware of which patients were assigned to the test group.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older 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 periodontitis (Stage 3)
- •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)
the test group were asked to brush their teeth, dip the interdental brush in HA gel, and use the dipped interdental brush.
干预措施: Interdental brush+HA (Device)
Control Group
the control group were asked to brush their teeth and use the interdental brush for oral hygiene.
干预措施: Interdental brush (Device)
结局指标
主要结局
Plaque index (PI)
时间窗: Baseline-4 weeks-12 weeks
Improvement in PI; lower scores mean a better outcome; Minimum score:0 Max.score: 5
Gingival index (GI)
时间窗: Baseline-4 weeks-12 weeks
Improvement in GI; lower scores mean a better outcome; Minimum score:0 Max.score: 3
Pocket depth (PD)
时间窗: Baseline-4 weeks-12 weeks
Improvement in PD; lower scores mean a better outcome
Papillary bleeding index (PBI)
时间窗: Baseline-4 weeks-12 weeks
Improvement in PBI; lower scores mean a better outcome; Minimum score:0 Max.score: 3
Clinical attachment loss (CAL)
时间窗: Baseline-4 weeks-12 weeks
Improvement in CAL; lower scores mean a better outcome
次要结局
未报告次要终点
研究者
Özlem SARAÇ ATAGÜN
assistant professor
Saglik Bilimleri Universitesi