Oral Mucositis
Conditions
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).
Interventions
DRUGchlorobutanol, hexetidine
3 times per day (after breakfast, lunch and dinner) for 1 minute with 15 ml of mouthwash
DRUGChlorhexidine
3 times per day (after breakfast, lunch and dinner) for 1 minute with 15 ml of mouthwash
Sponsors
Federico II University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
37 Years to 79 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events as a measure of tolerability | Weekly | Presence of mucosal lesions due to incongruous removable prostheses. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain scores on the visual analogue scale | Weekly | Lasting of painful symptomatology after rinsing. |
Countries
Italy
Outcome results
None listed