Text Size

Hexetidine and Chlorobutanol for Lesions Due to Prostheses

This study has been completed.
Sponsor:
Information provided by:
Federico II University
ClinicalTrials.gov Identifier:
NCT01115049
First received: April 21, 2010
Last updated: April 30, 2010
Last verified: April 2010
History of Changes

April 21, 2010
April 30, 2010
February 2010
March 2010   (final data collection date for primary outcome measure)
Number of participants with adverse events as a measure of tolerability [ Time Frame: Weekly ] [ Designated as safety issue: No ]
Presence of mucosal lesions due to incongruous removable prostheses.
Same as current
Complete list of historical versions of study NCT01115049 on ClinicalTrials.gov Archive Site
Pain scores on the visual analogue scale [ Time Frame: Weekly ] [ Designated as safety issue: No ]
Lasting of painful symptomatology after rinsing.
Same as current
Not Provided
Not Provided
 
Hexetidine and Chlorobutanol for Lesions Due to Prostheses
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

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.

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).
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Oral Mucositis
  • Drug: chlorobutanol, hexetidine
    3 times per day (after breakfast, lunch and dinner) for 1 minute with 15 ml of mouthwash
    Other Name: Curasept® ADS 0.20%, Curaden Healthcare
  • Drug: Chlorhexidine
    3 times per day (after breakfast, lunch and dinner) for 1 minute with 15 ml of mouthwash
    Other Name: Curasept® ADS 0.20%, Curaden Healthcare
  • Experimental: Experimental mouthwash
    The experimental mouthwash (Buccagel®, Curaden Healthcare, Saronno, Italy) was made up of: purified water, dicaprylyl-ether, coco-caprylate caprate, xylitol, glyceryl-stearate, ceteareth-20, ceteareth-12, cetyl-palmitate, cetearyl-alcohol, chlorobutanol, aroma, hexetidine, methylparaben, propylparaben, sodium saccharin, citric acid and colorant C.I. 16255.
    Intervention: Drug: chlorobutanol, hexetidine
  • Active Comparator: Chlorexidine-based mouthwash
    A conventional commercial mouthwash (Curasept® ADS 0.20%, Curaden Healthcare, Saronno, Italy) made up of: water, xylitol, propylenglycol, Peg-40 of hydrogenated ricin oil, ascorbic acid, chlorhexidine digluconate, aroma, poloxamer 407, sodium metabisulfite, sodium citrate and colorant C.I. 42090.
    Intervention: Drug: Chlorhexidine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
March 2010
March 2010   (final data collection date for primary outcome measure)

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.
Both
37 Years to 79 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01115049
FEDII_RS_1
Yes
Fernando Zarone, MD, DDS, Professor and Chair, University "Federico II" of Naples, Italy
Federico II University
Not Provided
Study Director: Fernando Zarone, MD, DDS University "Federco II" of Naples, Italy
Federico II University
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP