Xerostomia Due to Hyposecretion of Salivary GlandNCT03452085
The Artificial Saliva Spray Reduces Xerostomia in Diabetes Type II
A study testing artificial saliva spray (AS) and maritime throat spray (TT) in people with Xerostomia Due to Hyposecretion of Salivary Gland and Diabetes Mellitus, Type 2, run by Certmedica International GmbH at 1 site in Italy.
Trial summary
In diabetes Type II the xerostomia is a quite frequent symptom. In evaluating the activity of an artificial saliva spray compared to a water gel in patients with Diabetes Type II patients had to follow a three day treatment with each product. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Xerostomia Due to Hyposecretion of Salivary Gland, Diabetes Mellitus, Type 2
- What is being tested?
- artificial saliva spray (AS) and maritime throat spray (TT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteItaly
- Study dates
- 23 Sep 2017to 16 Jan 2018
- Phase
- Interventional
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- suffering xerostomia
- degree of xerostomia at least > 2 according to a semiquantal scare ranging from 0 to 6
- diabetes Type II > one year, with stabilized oral hypoglycemic therapy from at least 6 months.
- concomitant chronic diseases pertaining to dyslipidemia, cardiovascular and/or gastrointestinal diseases, and anxiety/depression were accepted provided under adequate therapy since at least 6 months.
Who cannot join
- under treatment for xerostomia or with xerostomia score < 2
- suffering from obesity (BMI > 30 kg/m2),
- cancer of any type
- drug addiction and alcoholism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Artificial Saliva in Diabetes Type II: a Randomized Registry Cross Over Study
In diabetes Type II the xerostomia is a quite frequent symptom. In evaluating the activity of an artificial saliva spray compared to a water gel in patients with Diabetes Type II patients had to follow a three day treatment with each product. Whereas after the first treatment period the two groups had to follow a wash out period of three days before the second treatment period could begin.
The artificial saliva spray reduced the xerostomia and the inflammation or the oral tissue.
Read the detailed description
In diabetes Type II the xerostomia is a quite frequent symptom. The trial was conducted at a single center. Designed and implementing UNI EN ISO 14155:2012, STROBE statement Version 4 and was in conformity with the guidelines of the Declaration of Helsinki.
The type of study was a randomized, cross over clinical trial to compare two treatments (artificial saliva spray (aldiamed(R) mouth spray) AS vs. (Tonimer(R) Throat Spray) TT .
Twenty one subjects that were part of the epidemiological screening for asymptomatic vascular diseases conducted in the Irwin Lab3 of Spoltore (PE / Italy) The degree of xerostomia for the admission had to be at least > 2 according to a semi-quantal scale (ranging from 0 to 6) and patients already under treatment for xerostomia or with xerostomia score < 2, suffering from obesity, cancer, drug addiction or alcoholism were excluded.
The patients had to follow a three day treatment with each product. Whereas after the first treatment period the two groups had to follow a wash out period of three days before the second treatment period could begin.
The study consisted of a preliminary selection during screening, the measurement of xerostomia and random allocation, first treatment period, wash out period and finally the second treatment period.
- Being tested
- artificial saliva spray (AS), maritime throat spray (TT)
- Keywords
- xerostomia, diabetes type II, salivary flow, antioxidant capacity of saliva, aldiamed
- Medical subject headings
- Diabetes Mellitus, Type 2, Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
artificial saliva spray (AS)Device
cross over design
maritime throat spray (TT)Other
cross over design
| Study group | Role | What they receive |
|---|---|---|
| artificial saliva spray (AS) | Active comparator | The randomized part of the participants who started first with the artificial saliva spray taking it three times a day for a three days treatment, followed by a wash out phase of 3 days.
After wash out phase they take for three days the marine water throat spray taking it three times a day for a three days treatment. Receives: Device: artificial saliva spray (AS); Other: maritime throat spray (TT) |
| maritime throat spray (TT) | Placebo comparator | The randomized part of the participants who started first with the marine water throat spray taking it three times a day for a three days treatment, followed by a wash out phase of 3 days.
After wash out phase they take for three days the artificial saliva spray taking it three times a day for a three days treatment. Receives: Device: artificial saliva spray (AS); Other: maritime throat spray (TT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
xerostomia
xerostomia was measured according to a semi-quantal visual scale (or VAS; visual analogue scale) ranging from 0 to 6 with intervals of 1 point
Measured: first day before treatment; change to third day after treatment (day 1+3; 7+9)
Secondary outcomes (3)
stimulated salivary flow
Subject was asked to chew a standard square of medical cotton for one minute rolling the cotton in the mouth in order to collect the saliva. The measure of the flow consisted in weighing the cotton before and after the chewing
Measured: first day before treatment; change to third day after treatment (day 1+3; 7+9)
antioxidant capacity of saliva (SAT test)
The test utilizes the capacity of thiocyanate (SCN) to react with iron (Fe3+) causing the formation of FE((SCN)6)3-.
Measured: first day before treatment; changes to third day after treatment (day 1+3; 7+9)
patients preference for treatment AS or TT
question in regard to the preference
Measured: third day after finalization of the treatment period (day 3; 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start23 Sep 2017
- Primary completion4 Nov 2017
- Study completion16 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Xerostomia Due to Hyposecretion of Salivary GlandStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Patients were randomized to two groups, whereas one group starts treatment with AS and the other group starts treatment with TT (control). After a wash out phase of 3 days, the patients have to take the other product for also 3 days. (e. g. randomized patient takes AS for 3 days, after a wash out period of 3 days he takes TT also for three days.)
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Certmedica International GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03452085
- Sponsor's protocol ID
- IAPSSAPP
- Status last verified
- Jan 2018
- First submitted
- 3 Feb 2018
- Last updated
- 2 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Saliva in Diabetes Type II: a Randomized Registry Cross Over Study
- ClinicalTrials.gov ID
- NCT03452085
- Acronym / sponsor ID
- IAPSSAPP
- Keywords
- xerostomia, diabetes type II, salivary flow, antioxidant capacity of saliva, aldiamed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Certmedica International GmbHIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2017 (actual)
- Primary completion
- 4 Nov 2017 (actual)
- Study completion
- 16 Jan 2018 (actual)
- First posted
- 2 Mar 2018 (actual)
- 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.
In diabetes Type II the xerostomia is a quite frequent symptom. In evaluating the activity of an artificial saliva spray compared to a water gel in patients with Diabetes Type II patients had to follow a three day treatment with each product. Whereas after the first treatment period the two groups had to follow a wash out period of three days before the second treatment period could begin.
The artificial saliva spray reduced the xerostomia and the inflammation or the oral tissue.
Detailed description
In diabetes Type II the xerostomia is a quite frequent symptom. The trial was conducted at a single center. Designed and implementing UNI EN ISO 14155:2012, STROBE statement Version 4 and was in conformity with the guidelines of the Declaration of Helsinki.
The type of study was a randomized, cross over clinical trial to compare two treatments (artificial saliva spray (aldiamed(R) mouth spray) AS vs. (Tonimer(R) Throat Spray) TT .
Twenty one subjects that were part of the epidemiological screening for asymptomatic vascular diseases conducted in the Irwin Lab3 of Spoltore (PE / Italy) The degree of xerostomia for the admission had to be at least > 2 according to a semi-quantal scale (ranging from 0 to 6) and patients already under treatment for xerostomia or with xerostomia score < 2, suffering from obesity, cancer, drug addiction or alcoholism were excluded.
The patients had to follow a three day treatment with each product. Whereas after the first treatment period the two groups had to follow a wash out period of three days before the second treatment period could begin.
The study consisted of a preliminary selection during screening, the measurement of xerostomia and random allocation, first treatment period, wash out period and finally the second treatment period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients were randomized to two groups, whereas one group starts treatment with AS and the other group starts treatment with TT (control). After a wash out phase of 3 days, the patients have to take the other product for also 3 days. (e. g. randomized patient takes AS for 3 days, after a wash out period of 3 days he takes TT also for three days.)
| Arm | Type | Receives |
|---|---|---|
| artificial saliva spray (AS) | Active comparator | Device: artificial saliva spray (AS), Other: maritime throat spray (TT)The randomized part of the participants who started first with the artificial saliva spray taking it three times a day for a three days treatment, followed by a wash out phase of 3 days. After wash out phase they take for three days the marine water throat spray taking it three times a day for a three days treatment. |
| maritime throat spray (TT) | Placebo comparator | Device: artificial saliva spray (AS), Other: maritime throat spray (TT)The randomized part of the participants who started first with the marine water throat spray taking it three times a day for a three days treatment, followed by a wash out phase of 3 days. After wash out phase they take for three days the artificial saliva spray taking it three times a day for a three days treatment. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- suffering xerostomia
- degree of xerostomia at least > 2 according to a semiquantal scare ranging from 0 to 6
- diabetes Type II > one year, with stabilized oral hypoglycemic therapy from at least 6 months.
- concomitant chronic diseases pertaining to dyslipidemia, cardiovascular and/or gastrointestinal diseases, and anxiety/depression were accepted provided under adequate therapy since at least 6 months.
Key exclusion criteria (4 listed)
- under treatment for xerostomia or with xerostomia score < 2
- suffering from obesity (BMI > 30 kg/m2),
- cancer of any type
- drug addiction and alcoholism
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 |
|---|---|---|
| artificial saliva spray (AS)cross over design | Device | artificial saliva spray (AS), maritime throat spray (TT) |
| maritime throat spray (TT)cross over design | Other | artificial saliva spray (AS), maritime throat spray (TT) |
Primary outcome
xerostomia
Time frame: first day before treatment; change to third day after treatment (day 1+3; 7+9)
xerostomia was measured according to a semi-quantal visual scale (or VAS; visual analogue scale) ranging from 0 to 6 with intervals of 1 point
3 secondary outcomes
stimulated salivary flow
Time frame: first day before treatment; change to third day after treatment (day 1+3; 7+9)
antioxidant capacity of saliva (SAT test)
Time frame: first day before treatment; changes to third day after treatment (day 1+3; 7+9)
patients preference for treatment AS or TT
Time frame: third day after finalization of the treatment period (day 3; 9)
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 2 Mar 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing artificial saliva spray (AS) and maritime throat spray (TT) in people with Xerostomia Due to Hyposecretion of Salivary Gland and Diabetes Mellitus, Type 2, run by Certmedica International GmbH 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 4 inclusion and 4 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 2 Mar 2018. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
xerostomia (time frame: first day before treatment; change to third day after treatment (day 1+3; 7+9)). 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 2 Mar 2018.