Evaluation of the Efficacy of a Hexetidine- and Chlorobutanol-based Mouthwash in the Symptomatic Treatment of Oral Lesions Due to Removable Prostheses: a Prospective, Randomized, Triple-blind Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events as a measure of tolerability
研究概览
简要总结
Objectives: The study aimed at assessing the efficacy of a new mouthwash in treating oral lesions due to removable prostheses.
Methods: The present prospective randomized clinical trial was performed on 44 patients. The experimentation lasted for 4 weeks and 4 operators participated. The effects of the mouthwash were evaluated subjectively and objectively, with questionnaires, Visual Analogic Scales and clinical examinations. The results were statistically analyzed. The following variables were recorded: presence of mucosal lesions due to incongruous removable prostheses and lasting of pain after rinsing.
详细描述
The aim of the present prospective, randomized, triple-blind controlled clinical trial was to evaluate the efficacy of an innovative mouthwash (emulsion) in the treatment of lesions of oral mucosae due to removable prostheses. The tested preparation contained two active molecules: a topical antiseptic (0.1% hexetidine) and a local anesthetic (0.5% chlorobutanol).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 37 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Use of removable partial or complete dentures;
- •Presence of lesions of oral mucosae due to dentures;
- •Absence of any concomitant local or systemic pathology;
- •Absence of pregnancy or breastfeeding;
- •Negative allergic anamnesis;
- •Negative anamnesis for recurrent aphthous stomatitis;
- •No taking medicines with potential pharmacologic interactions with molecules to be tested;
- •No taking antibiotics and/or painkillers for at least 6 months before entering the experimentation;
- •Good oral hygiene with a full-mouth plaque score ≤25%;
- •Non smoking or light smoking (≤10 cigarettes/day) status.
排除标准
- •Missing one or more of the above described conditions automatically excluded a subject from the study.
研究组 & 干预措施
Experimental mouthwash
The experimental mouthwash (Buccagel®, Curaden Healthcare, Saronno, Italy) was made up of: purified water, dicaprylyl-ether, coco-caprylate caprate, xylitol, glyceryl-stearate, ceteareth-20, ceteareth-12, cetyl-palmitate, cetearyl-alcohol, chlorobutanol, aroma, hexetidine, methylparaben, propylparaben, sodium saccharin, citric acid and colorant C.I. 16255.
干预措施: chlorobutanol, hexetidine (Drug)
Chlorexidine-based mouthwash
A conventional commercial mouthwash (Curasept® ADS 0.20%, Curaden Healthcare, Saronno, Italy) made up of: water, xylitol, propylenglycol, Peg-40 of hydrogenated ricin oil, ascorbic acid, chlorhexidine digluconate, aroma, poloxamer 407, sodium metabisulfite, sodium citrate and colorant C.I. 42090.
干预措施: Chlorhexidine (Drug)
结局指标
主要结局
Number of participants with adverse events as a measure of tolerability
时间窗: Weekly
Presence of mucosal lesions due to incongruous removable prostheses.
次要结局
- Pain scores on the visual analogue scale(Weekly)