Effectiveness of HydrogenPeroxie, Hyaluronic Acid, Chlorhexidine Mouthwashes in Gingivitis Management: A Randomized, Triple-Blind, Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Gingival Index (GI) from baseline to week 3
研究概览
简要总结
This randomized, triple-blind clinical trial is designed to evaluate the efficacy of four different mouthwash formulations - hydrogen peroxide with hyaluronic acid, hyaluronic acid alone, chlorhexidine, and placebo - in four parallel arms. The study will take place at multiple centers, starting on June 1, 2025, and is expected to conclude by October 1, 2026. There is no external funding source for this study.
Eligible participants include systemically healthy individuals aged 18 to 35 years with a gingival and plaque index score of 1 or higher. Individuals with systemic or oral diseases will be excluded. Participants will be randomly assigned to one of four groups, each receiving a different mouthwash formulation for twice-daily use, following standardized oral hygiene instructions.
The potential benefit includes a reduced risk of gingivitis progression to periodontitis. There are no significant anticipated risks, though mild oral discomfort or taste alteration may occur.
详细描述
This randomized, triple-blind clinical trial aims to compare the effectiveness and safety of four different mouthwash formulations in managing gingivitis. The test group will use a mouthwash containing hydrogen peroxide (H2O2 1.80% )and hyaluronic acid (HA 0.10%). The three comparator groups will receive either chlorhexidine (CHX 0.12%), hyaluronic acid (HA 0.12%) (high molecular weight) alone, or a placebo mouthwash.
A total of four parallel arms will be used. Participants will be randomly assigned using a computer-generated randomization list. Blinding will apply to participants, clinical evaluators, and data analysts to maintain objectivity (triple-blind design).
Each participant will use the assigned mouthwash twice daily for three weeks, following standard oral hygiene instructions.
The primary outcomes will be changes in gingival inflammation, plaque accumulation, and bleeding on probing, assessed using the Gingival Index (GI), Plaque Index (PI), and Bleeding on Probing (BOP). Measurements will be taken at baseline, and after one, two, and three weeks of intervention.
The secondary outcomes will include reported side effects such as taste alteration, tooth discoloration, and overall comfort using the mouthwash.
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 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects with a gingival index score of 1 or greater.
- •Subjects with a plaque index score of 1 or greater
- •Systemically healthy individuals.
- •Minimum of 20 natural teeth
排除标准
- •Current use of any mouthwash.
- •Smoking habit.
- •Presence of active caries.
- •Overhanged restorations and crowns.
- •Presence of supra or subgingival calculus.
- •Ongoing orthodontic treatment (including post-treatment retainer)
- •Periodontal treatment within the past 6 months and a diagnosis of periodontitis.
- •Use of antibiotics within the past 4 months or requirement for antibiotic prophylaxis.
- •Systematic or topical non-steroidal anti-inflammatory drug treatment for the past 4 months
- •Pregnancy or lactation.
- •History of heart valve replacement.
- •Known intolerance or allergy to mouth rinses.
结局指标
主要结局
Change in Gingival Index (GI) from baseline to week 3
时间窗: Baseline, Week 1, Week 2, Week 3
Mean Gingival Index score per participant, assessed on six sites per tooth. Score range: 0 (normal) to 3 (severe inflammation).
Change in Plaque Index (PI) from baseline to week 3
时间窗: Baseline, week 1, week 2, week 3
Mean Plaque Index score per participant, assessed using the Silness and Löe method-score range: 0 (no plaque) to 3 (abundant plaque).
Change in Bleeding on Probing (BOP) from baseline to week 3
时间窗: baseline, week 1, week 2, week 3
Percentage of sites showing bleeding on probing, recorded within 30 seconds after probing. Range: 0% to 100%.
次要结局
- Change in Discomfort score after mouthwash use(After 3 weeks of mouthwash use)
- Change in taste perception after mouthwash use(After 3 weeks of mouthwash use)
- Change in tooth color shade assessed by VITA easy shade LITE(At baseline and after 3 weeks of mouthwash use)
研究者
Ramziyah Hayder Bakr
Board Candidate in Dental Public Health
Kurdistan Higher Council of Medical Specialties