NCT01115049

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Federico II University · Academic / Other
• Sex: All
• Age: 37 Years – 79 Years
• Healthy volunteers: Accepted

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.

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).

Conditions

• Oral Mucositis

Interventions

Type	Name	Description
DRUG	chlorobutanol, hexetidine	3 times per day (after breakfast, lunch and dinner) for 1 minute with 15 ml of mouthwash
DRUG	Chlorhexidine	3 times per day (after breakfast, lunch and dinner) for 1 minute with 15 ml of mouthwash

Timeline

• Start date: 2010-02-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2010-05-03
• Last updated: 2010-05-03

Locations

1 site across 1 country: Italy