Oral MucositisPhase 4NCT01115049
Hexetidine and Chlorobutanol for Lesions Due to Prostheses
A Phase 4 study testing chlorobutanol, hexetidine and Chlorhexidine in people with Oral Mucositis, run by Federico II University at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 37 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- chlorobutanol, hexetidine and Chlorhexidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2010to Mar 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 37 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- Missing one or more of the above described conditions automatically excluded a subject from the study.
Trial locations and contacts
1 site in 1 country.
Italy1 site
University "Federico II", Department of Prosthodontics
Naples, 80131
About this study
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
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.
Read the 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).
- Conditions
- Oral Mucositis
- Being tested
- chlorobutanol, hexetidine, Chlorhexidine
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chlorobutanol, hexetidineDrug
Also called Curasept® ADS 0.20%, Curaden Healthcare
3 times per day (after breakfast, lunch and dinner) for 1 minute with 15 ml of mouthwash
ChlorhexidineDrug
Also called Curasept® ADS 0.20%, Curaden Healthcare
3 times per day (after breakfast, lunch and dinner) for 1 minute with 15 ml of mouthwash
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: chlorobutanol, hexetidine |
| 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. Receives: Drug: Chlorhexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events as a measure of tolerability
Presence of mucosal lesions due to incongruous removable prostheses.
Measured: Weekly
Secondary outcomes (1)
Pain scores on the visual analogue scale
Lasting of painful symptomatology after rinsing.
Measured: Weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2010 (estimated)
- Study startFeb 2010
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Investigators
- Fernando Zarone, MD, DDS, Study director, University "Federco II" of Naples, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115049
- Sponsor's protocol ID
- FEDII_RS_1
- Status last verified
- Apr 2010
- First submitted
- 21 Apr 2010
- Last updated
- 3 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01115049
- Acronym / sponsor ID
- FEDII_RS_1
- Conditions
- Oral Mucositis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 3 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental mouthwash | Experimental | Drug: chlorobutanol, hexetidineThe 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 | Drug: ChlorhexidineA 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. |
Who may qualify
- Ages
- 37 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (1 listed)
- Missing one or more of the above described conditions automatically excluded a subject from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chlorobutanol, hexetidineAlso: Curasept® ADS 0.20%, Curaden Healthcare3 times per day (after breakfast, lunch and dinner) for 1 minute with 15 ml of mouthwash | Drug | Experimental mouthwash |
| ChlorhexidineAlso: Curasept® ADS 0.20%, Curaden Healthcare3 times per day (after breakfast, lunch and dinner) for 1 minute with 15 ml of mouthwash | Drug | Chlorexidine-based mouthwash |
Primary outcome
Number of participants with adverse events as a measure of tolerability
Time frame: Weekly
Presence of mucosal lesions due to incongruous removable prostheses.
1 secondary outcome
Pain scores on the visual analogue scale
Time frame: Weekly
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando Zarone, MD, DDS study director
University "Federco II" of Naples, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing chlorobutanol, hexetidine and Chlorhexidine in people with Oral Mucositis, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events as a measure of tolerability (time frame: Weekly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2010.