A Phase 4 interventional study of chlorobutanol, hexetidine and Chlorhexidine in Oral Mucositis, sponsored by Federico II University. Completed at 1 site in Italy. Open to participants aged 37 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-05-03.
Sponsored by Federico II University · Phase 4, Interventional, and Supportive care
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).
488 studies on the registry are indexed under Mucositis; 70 are open to participants now.
This study's enrollment of 44 is below the median of 50 across 394 interventional studies indexed under Mucositis.
Browse Mucositis studies →Federico II University is the lead sponsor of 356 studies on the registry; 60 are open to participants now.
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Exclusion Criteria:
Missing one or more of the above described conditions automatically excluded a subject from the study.
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
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
Also known as: Curasept® ADS 0.20%, Curaden Healthcare
3 times per day (after breakfast, lunch and dinner) for 1 minute with 15 ml of mouthwash
Also known as: Curasept® ADS 0.20%, Curaden Healthcare
Number of participants with adverse events as a measure of tolerability
Presence of mucosal lesions due to incongruous removable prostheses.
Time frame: Weekly
Pain scores on the visual analogue scale
Lasting of painful symptomatology after rinsing.
Time frame: Weekly
This study is completed, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.
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Federico II University