Overview
Hexetidine and Chlorobutanol for Lesions Due to Prostheses
Status:
Completed
Completed
Trial end date:
2010-03-01
2010-03-01
Target enrollment:
0
0
Participant gender:
All
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 4Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Federico II UniversityTreatments:
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.