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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental mouthwash | Experimental | 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. |
|
| Chlorexidine-based mouthwash | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chlorobutanol, hexetidine | Drug | 3 times per day (after breakfast, lunch and dinner) for 1 minute with 15 ml of mouthwash |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as a measure of tolerability | Presence of mucosal lesions due to incongruous removable prostheses. | Weekly |
| Measure | Description | Time Frame |
|---|---|---|
| Pain scores on the visual analogue scale | Lasting of painful symptomatology after rinsing. | Weekly |
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Inclusion Criteria:
Exclusion Criteria:
Missing one or more of the above described conditions automatically excluded a subject from the study.
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| Name | Affiliation | Role |
|---|---|---|
| Fernando Zarone, MD, DDS | University "Federco II" of Naples, Italy | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University "Federico II", Department of Prosthodontics | Naples | 80131 | Italy |
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| ID | Term |
|---|---|
| D013280 | Stomatitis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D002724 | Chlorobutanol |
| D006590 | Hexetidine |
| D002710 | Chlorhexidine |
| ID | Term |
|---|---|
| D002728 | Chlorohydrins |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000440 | Butanols |
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| Chlorhexidine | Drug | 3 times per day (after breakfast, lunch and dinner) for 1 minute with 15 ml of mouthwash |
|
|
| D005233 |
| Fatty Alcohols |
| D008055 | Lipids |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |