Hexetidine and Chlorobutanol for Lesions Due to Prostheses

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

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.

Study Overview

• Status: Completed
• Conditions: Oral Mucositis
• Intervention / Treatment: Drug: chlorobutanol, hexetidine; Drug: Chlorhexidine

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80131
    • University "Federico II", Department of Prosthodontics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 37 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Federico II University
• Investigators: Study Director: Fernando Zarone, MD, DDS, University "Federco II" of Naples, Italy

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: April 21, 2010
• First Submitted That Met QC Criteria: April 30, 2010
• First Posted (Estimate): May 3, 2010

Study Record Updates

• Last Update Posted (Estimate): May 3, 2010
• Last Update Submitted That Met QC Criteria: April 30, 2010
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Mucositis; Stomatitis; Anti-Infective Agents, Local; Anti-Infective Agents; Antifungal Agents; Disinfectants; Chlorhexidine; Hexetidine
• Other Study ID Numbers: FEDII_RS_1