Hexetidine and Chlorobutanol for Lesions Due to Prostheses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01115049
Recruitment Status : Completed
First Posted : May 3, 2010
Last Update Posted : May 3, 2010
Information provided by:
Federico II University

Brief 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.

Condition or disease Intervention/treatment Phase
Oral Mucositis Drug: chlorobutanol, hexetidine Drug: Chlorhexidine Phase 4

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : February 2010
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

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MedlinePlus related topics: Artificial Limbs

Arm Intervention/treatment
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

Primary Outcome Measures :
  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 Outcome Measures :
  1. Pain scores on the visual analogue scale [ Time Frame: Weekly ]
    Lasting of painful symptomatology after rinsing.

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Ages Eligible for Study:   37 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01115049

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

Responsible Party: Fernando Zarone, MD, DDS, Professor and Chair, University "Federico II" of Naples, Italy Identifier: NCT01115049     History of Changes
Other Study ID Numbers: FEDII_RS_1
First Posted: May 3, 2010    Key Record Dates
Last Update Posted: May 3, 2010
Last Verified: April 2010

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Dermatologic Agents
Antifungal Agents