Hexetidine and Chlorobutanol for Lesions Due to Prostheses

Federico II University

Status and phase: Completed; Phase 4

Conditions: Oral Mucositis

Treatments: Drug: chlorobutanol, hexetidine; Drug: Chlorhexidine

Study type: Interventional

Funder types: Other

Identifiers

NCT01115049

FEDII_RS_1

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 44 patients

Sex: All

Ages: 37 to 79 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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44 participants in 2 patient groups

Experimental mouthwash

Experimental group

Description:

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.

Treatment:

Drug: chlorobutanol, hexetidine

Chlorexidine-based mouthwash

Active Comparator group

Description:

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.

Treatment:

Drug: Chlorhexidine