Back to resultsHexetidine and Chlorobutanol for Lesions Due to Prostheses
Primary Purpose
Oral Mucositis
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
chlorobutanol, hexetidine
Chlorhexidine
Sponsored by
About this trial
This is an interventional supportive care trial for Oral Mucositis
Eligibility 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.
Sites / Locations
- University "Federico II", Department of Prosthodontics
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental mouthwash
Chlorexidine-based mouthwash
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Number of participants with adverse events as a measure of tolerability
Presence of mucosal lesions due to incongruous removable prostheses.
Secondary Outcome Measures
Pain scores on the visual analogue scale
Lasting of painful symptomatology after rinsing.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01115049
Brief Title
Hexetidine and Chlorobutanol for Lesions Due to Prostheses
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 Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Federico II University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental mouthwash
Arm Type
Experimental
Arm Description
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.
Arm Title
Chlorexidine-based mouthwash
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
chlorobutanol, hexetidine
Other Intervention Name(s)
Curasept® ADS 0.20%, Curaden Healthcare
Intervention Description
3 times per day (after breakfast, lunch and dinner) for 1 minute with 15 ml of mouthwash
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine
Other Intervention Name(s)
Curasept® ADS 0.20%, Curaden Healthcare
Intervention Description
3 times per day (after breakfast, lunch and dinner) for 1 minute with 15 ml of mouthwash
Primary Outcome Measure Information:
Title
Number of participants with adverse events as a measure of tolerability
Description
Presence of mucosal lesions due to incongruous removable prostheses.
Time Frame
Weekly
Secondary Outcome Measure Information:
Title
Pain scores on the visual analogue scale
Description
Lasting of painful symptomatology after rinsing.
Time Frame
Weekly
10. Eligibility
Sex
All
Minimum Age & Unit of Time
37 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando Zarone, MD, DDS
Organizational Affiliation
University "Federco II" of Naples, Italy
Official's Role
Study Director
Facility Information:
Facility Name
University "Federico II", Department of Prosthodontics
City
Naples
ZIP/Postal Code
80131
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Hexetidine and Chlorobutanol for Lesions Due to Prostheses
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