Skip to main content
OpenTrials
Completed

NCT Number: NCT01115049

Hexetidine and Chlorobutanol for Lesions Due to Prostheses

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Oral Mucositis Mouth Diseases Stomatitis Stomatognathic Diseases

Age range

37 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University "Federico II", Department of Prosthodontics

Naples, 80131, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

chlorobutanol, hexetidine

Drug

3 times per day (after breakfast, lunch and dinner) for 1 minute with 15 ml of mouthwash

Other names: Curasept® ADS 0.20%, Curaden Healthcare

Chlorhexidine

Drug

3 times per day (after breakfast, lunch and dinner) for 1 minute with 15 ml of mouthwash

Other names: Curasept® ADS 0.20%, Curaden Healthcare

Primary outcomes

  1. Number of participants with adverse events as a measure of tolerability

    Time frame: Weekly

    Presence of mucosal lesions due to incongruous removable prostheses.

Secondary outcomes

  1. Pain scores on the visual analogue scale

    Time frame: Weekly

    Lasting of painful symptomatology after rinsing.

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 3, 2010
Registry last updated
May 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.