Hexetidine and Chlorobutanol for Lesions Due to Prostheses
NCT ID: NCT01115049
Last Updated: 2010-05-03
Study Results
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Basic Information
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COMPLETED
PHASE4
44 participants
INTERVENTIONAL
2010-02-28
2010-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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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.
chlorobutanol, hexetidine
3 times per day (after breakfast, lunch and dinner) for 1 minute with 15 ml of mouthwash
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.
Chlorhexidine
3 times per day (after breakfast, lunch and dinner) for 1 minute with 15 ml of mouthwash
Interventions
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chlorobutanol, hexetidine
3 times per day (after breakfast, lunch and dinner) for 1 minute with 15 ml of mouthwash
Chlorhexidine
3 times per day (after breakfast, lunch and dinner) for 1 minute with 15 ml of mouthwash
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
37 Years
79 Years
ALL
Yes
Sponsors
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Federico II University
OTHER
Responsible Party
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University "Federico II" of Naples, Italy
Principal Investigators
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Fernando Zarone, MD, DDS
Role: STUDY_DIRECTOR
University "Federco II" of Naples, Italy
Locations
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University "Federico II", Department of Prosthodontics
Naples, , Italy
Countries
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Other Identifiers
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FEDII_RS_1
Identifier Type: -
Identifier Source: org_study_id
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