Effect of Benzydamine Hydrochloride During Short-term Restricted Oral Hygiene: a Randomized, Placebo-controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 3-day plaque accumulation assessed by Plaque Control Record (PCR)
研究概览
简要总结
The goal of this clinical trial is to evaluate the effect of a mouthrinse containing an active ingredient benzydamine hydrochloride in the absence of daily oral hygiene. The study includes periodontally healthy female subjects and experimental phase will last for three days. Plaque accumulation is the primary evaluated outcome, measured by a particular periodontal index called Plaque Control Record (PCR). Gingival inflammation (bleeding) is the secondary evaluated outcome, measured by a particular periodontal index called Bleeding on Probing (BoP). Researchers will compare benzyadamine hydrochloride mouthrinse to a placebo (a look-alike substance that contains no active ingredient) mouthwash to see whether benzydamine hydrochloride use results in greater plaque accumulation.
详细描述
This study is designed as a randomized, double-blind, placebo-controlled, parallel-group clinical trial to evaluate the effects of a benzydamine hydrochloride-containing mouthrinse on supragingival plaque accumulation and gingival inflammatory response under conditions of restricted mechanical oral hygiene. The experimental model is based on a short-term plaque regrowth protocol, enabling controlled assessment of the chemical effects of the investigational product in the absence of confounding mechanical plaque removal.
A total of 50 periodontally healthy female participants will be enrolled and randomly assigned to either the test group (benzydamine hydrochloride mouthrinse) or the control group (placebo mouthrinse). Randomization will be performed using a predefined allocation sequence to ensure balanced group distribution. Both participants and investigators will be blinded to group assignment, with the test and placebo formulations matched in color, taste, and packaging to maintain allocation concealment.
Prior to the experimental phase, all participants will receive professional dental prophylaxis to establish a standardized baseline with minimal plaque accumulation and absence of gingival inflammation. Following this, subjects will be instructed to refrain from all mechanical oral hygiene procedures, including toothbrushing and interdental cleaning, for the duration of the 3-day experimental period.
During the experimental phase, participants will use the assigned mouthrinse twice daily, rinsing with 15 mL of solution for a standardized duration according to detailed written instructions.
The investigational product contains benzydamine hydrochloride, a locally acting non-steroidal anti-inflammatory agent with analgesic and anti-inflammatory properties, which may influence gingival tissue response and potentially affect plaque accumulation dynamics. The placebo formulation is devoid of active pharmacological ingredients but is otherwise identical in formulation characteristics to ensure effective blinding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •dentate subjects with at least 24 healthy teeth
- •no history of periodontal disease, confirmed by a clinically healthy periodontium, defined as probing pocket depth (PPD) ≤ 3 mm and no interdental clinical attachment loss
排除标准
- •pregnant or lactating females
- •using hormonal contraceptives
- •reporting systemic diseases or pharmacological treatment that could affect gingival inflammation
- •use of antibiotics within 6 months before the study
研究组 & 干预措施
Benzydamine Hydrochloride mouthrinse
Experimental arm participants will use the assigned mouthrinse containing benzydamine hydrochloride twice daily, rinsing with 15 mL of solution for a standardized duration according to the manufacturer's instructions.
干预措施: Benzydamine hydrochloride mouthrinse (Drug)
Placebo mouthrinse
Placebo mouthwash arm participants will use the assigned placebo mouthrinse, formulated to be identical in color, taste, and packaging to ensure effective allocation concealment. The mouthrinse will be used twice daily, with 15 mL of solution, following a standardized rinsing duration in accordance with the manufacturer's instructions.
干预措施: Placebo mouthrinse (Other)
结局指标
主要结局
3-day plaque accumulation assessed by Plaque Control Record (PCR)
时间窗: Baseline (Day 0) and Day 3
Plaque accumulation will be evaluated using the Plaque Control Record (PCR), which assesses the presence or absence of supragingival plaque on six surfaces of each tooth. The results will be expressed as the percentage of plaque-positive surfaces relative to the total number of examined surfaces, providing a quantitative measure of plaque regrowth under conditions of suspended mechanical oral hygiene.
次要结局
- 3-day gingival inflammation assessed by Bleeding on Probing (BoP)(Baseline (Day 0) and Day 3)
研究者
Ivan Puhar
Associate Professor
University of Zagreb