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Hexetidine and Chlorobutanol for Lesions Due to Prostheses

NCT01115049 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2010-05-03

No results posted yet for this study

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.

Conditions

  • Oral Mucositis

Interventions

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

Sponsors & Collaborators

  • Federico II University

    lead OTHER

Principal Investigators

  • Fernando Zarone, MD, DDS · University "Federco II" of Naples, Italy

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
37 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01115049 on ClinicalTrials.gov