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
  Purpose

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.


Condition Intervention Phase
Oral Mucositis
Drug: chlorobutanol, hexetidine
Drug: Chlorhexidine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official 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

Resource links provided by NLM:


Further study details as provided by Federico II University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Pain scores on the visual analogue scale [ Time Frame: Weekly ] [ Designated as safety issue: No ]
    Lasting of painful symptomatology after rinsing.


Enrollment: 44
Study Start Date: February 2010
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   37 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01115049

Locations
Italy
University "Federico II", Department of Prosthodontics
Naples, Italy, 80131
Sponsors and Collaborators
Federico II University
Investigators
Study Director: Fernando Zarone, MD, DDS University "Federco II" of Naples, Italy
  More Information

No publications provided

Responsible Party: Fernando Zarone, MD, DDS, Professor and Chair, University "Federico II" of Naples, Italy
ClinicalTrials.gov Identifier: NCT01115049     History of Changes
Other Study ID Numbers: FEDII_RS_1
Study First Received: April 21, 2010
Last Updated: April 30, 2010
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Additional relevant MeSH terms:
Stomatitis
Mucositis
Mouth Diseases
Stomatognathic Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Chlorhexidine
Chlorhexidine gluconate
Hexetidine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents
Antifungal Agents

ClinicalTrials.gov processed this record on August 21, 2014