Hexetidine and Chlorobutanol for Lesions Due to Prostheses

Oral Mucositis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01115049
• Other study ID #: FEDII_RS_1
• Status: Completed
• Phase: Phase 4
• First received: April 21, 2010
• Last updated: April 30, 2010
• Start date: February 2010
• Est. completion date: March 2010

Study information

• Verified date: April 2010
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 37 Years to 79 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Oral Mucositis
• Stomatitis

Intervention

Drug:
• chlorobutanol, hexetidine
3 times per day (after breakfast, lunch and dinner) for 1 minute with 15 ml of mouthwash
• Chlorhexidine
3 times per day (after breakfast, lunch and dinner) for 1 minute with 15 ml of mouthwash

Locations

Country	Name	City	State
Italy	University "Federico II", Department of Prosthodontics	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events as a measure of tolerability	Presence of mucosal lesions due to incongruous removable prostheses.	Weekly	No
Secondary	Pain scores on the visual analogue scale	Lasting of painful symptomatology after rinsing.	Weekly	No