Hexetidine and Chlorobutanol for Lesions Due to Prostheses

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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

Conditions
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Oral Mucositis

Intervention / Treatment
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* Drug: chlorobutanol, hexetidine
* Drug: Chlorhexidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Missing one or more of the above described conditions automatically excluded a subject from the study.

Ages Eligible for Study
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Minimum Age: 37 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental mouthwash<br>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. | Drug: chlorobutanol, hexetidine<br>* 3 times per day (after breakfast, lunch and dinner) for 1 minute with 15 ml of mouthwash<br>* Other names: Curasept® ADS 0.20%, Curaden Healthcare;|
| Active Comparator: Chlorexidine-based mouthwash<br>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. | Drug: Chlorhexidine<br>* 3 times per day (after breakfast, lunch and dinner) for 1 minute with 15 ml of mouthwash<br>* Other names: Curasept® ADS 0.20%, Curaden Healthcare;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events as a measure of tolerability | Presence of mucosal lesions due to incongruous removable prostheses. | Weekly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores on the visual analogue scale | Lasting of painful symptomatology after rinsing. | Weekly |