Hexetidine and Chlorobutanol for Lesions Due to Prostheses

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Federico II University
• Treatments: Chlorhexidine; Chlorhexidine gluconate; Hexetidine

Criteria

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.