Overview

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.