XerostomiaPhase 4NCT03578900
Quality of Life and Sjögren Syndrome
A Phase 4 study testing Xeros and Citric Acid based Mouthwash in people with Xerostomia and Hyposalivation, run by Grupo de Investigação em Bioquímica e Biologia Oral.
Trial summary
The aims of this study are: To compare salivary pH changes and stimulation efficacy of two different Gustatory Stimulants of Salivation (GSSS) in patients with Primary Sjögren Syndrome (PSS); To evaluate Primary Sjögren syndrome (PSS) impact and gustatory stimulants of salivary secretion (GSSS) on oral health related… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Xerostomia, Hyposalivation, Quality of Life
- What is being tested?
- Xeros and Citric Acid based Mouthwash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 289 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 31 Dec 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- unstimulated whole saliva secretion rate < 0.1 ml/min
- stimulated whole saliva secretion rate > 0.2 ml/min
- above 18 years of age
- Primary Sjogren Syndrome diagnostic according to the European-American Consensus Group
Who cannot join
- wearer of complete dental prosthesis
- those who were pregnant or lactating
- non-speakers of Portuguese.
About this study
Official title: Quality of Life in a Portuguese Population With Primary Sjögren Syndrome
The aims of this study are: To compare salivary pH changes and stimulation efficacy of two different Gustatory Stimulants of Salivation (GSSS) in patients with Primary Sjögren Syndrome (PSS); To evaluate Primary Sjögren syndrome (PSS) impact and gustatory stimulants of salivary secretion (GSSS) on oral health related quality of life measured by a Portuguese version of Oral Health Impact Profile-14 (OHIP-14) and specific Xerostomia assessment questionnaires.
The Products to be used are the Xeros® Dentaid system and a citric based mouthwash.
- Conditions
- Xerostomia, Hyposalivation, Quality of Life, Sjogren's Syndrome
- Being tested
- Xeros, Citric Acid based Mouthwash
- Keywords
- Xerostomia, Hyposalivation, Quality of Life, Sjogren's Syndrome
- Medical subject headings
- Xerostomia, Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XerosDrug
Citric Acid based MouthwashDrug
| Study group | Role | What they receive |
|---|---|---|
| Xeros Group - Lozenge | Experimental | Application of Xeros system for 15 days. Lozenge (Malic acid 28.56 mg, Xylitol 421,98 mg, Sodium fluoride 0.55 mg) or Spray (Malic acid 1%, Xylitol 10%, Sodium fluoride 0.05%) 4 times a day. Effects on Xerostomia and Quality of Life were determined before and after application by answering the questionnaires.
Effects of lozenge on hyposalivation and pH variation determined by saliva collection with pre-weighed falcon and a ph electrode at predetermined times during a 20 minute period. Receives: Drug: Xeros |
| Mouthwash group | Active comparator | Application of citric acid based Mouthwash (0,33% citric acid) for 15 days four times a day. Effects on Xerostomia and Quality of Life were determined before and after application by answering the questionnaires.
Effects of mouthwash on hyposalivation and pH variation determined by saliva collection with pre-weighed falcon and a pH electrode at predetermined times during a 20 minute period. Receives: Drug: Citric Acid based Mouthwash |
| Xeros Group - Mouthwash | Experimental | Application of Xeros system for 15 days. Mouthwash (Betaine 1.33%, Xylitol 3.30%, Sodium fluoride 0.05%, Allantoin 0.10%) 2 times a day.
Effects on Xerostomia and Quality of Life were determined before and after application by answering the questionnaires. Receives: Drug: Xeros |
| Xeros Group - Gel | Experimental | Application of Xeros system for 15 days. Gel (Betaine 1%, Aloe Vera 0.05%, Xylitol 10%, Sodium Fluoride 0.0033%) before bed.
Effects on Xerostomia and Quality of Life were determined before and after application by answering the questionnaires. Receives: Drug: Xeros |
| Xeros Group - Toothpaste | Experimental | Application of Xeros system for 15 days. Toothpaste (Betaine 4%, Xylitol 10%, Sodium Fluoride 0.33%, Allantoin 0.10%) 3 times a day.
Effects on Xerostomia and Quality of Life were determined before and after application by answering the questionnaires. Receives: Drug: Xeros |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of GSSS induced pH drop below 4.5
On the day that the system is attributed the subject is asked to use one of the products and saliva is collected. pH variation is determined at fixed intervals during 20 minutes. Time in which salivary pH is below 4.5 is calculated as well as the number needed to treat and the absolute risk reduction.
Measured: 20 minutes
Overall and sub domains scores for each questionnaire
Before and after usage of both products at home, the Summated Xerostomia Inventory-5 (range 0 to 15) to measure subjective feeling of dry mouth, Oral Health Impact Profile-14 (range 0 to 56) to measure quality of life perception related to the oral cavity. This last questionnaire is further divided into 7 subdomains: functional limitation, physical pain, psychological discomfort, physical disability, psychologic disability, social disability and handicap each ranging from 0 to 14.
In both questionnaires the total score is the result of the sum of the individual scores in each question.
In both questionnaires the higher the score the worse the outcome. The before and after scores obtained are then compared.
Measured: 15 days
Secondary outcomes (1)
Salivary stimulant induced salivary flow
While using one of the two products saliva is collected, weighed and salivary flow is determined at fixed times during 20 minutes.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start1 Jan 2013
- Primary completion31 Dec 2014
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for XerostomiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo de Investigação em Bioquímica e Biologia Oral
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lisbon, Portuguese Institute of Rheumatology, Dentaid SL
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578900
- Sponsor's protocol ID
- QL2015
- Status last verified
- Jul 2018
- First submitted
- 18 May 2018
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life in a Portuguese Population With Primary Sjögren Syndrome
- ClinicalTrials.gov ID
- NCT03578900
- Acronym / sponsor ID
- QL2015
- Conditions
- Xerostomia, Hyposalivation, Quality of Life, Sjogren's Syndrome
- Keywords
- Xerostomia, Hyposalivation, Quality of Life, Sjogren's Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- Grupo de Investigação em Bioquímica e Biologia OralUniversity, hospital or other
- Collaborators
- University of Lisbon, Portuguese Institute of Rheumatology, Dentaid SL
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 6 Jul 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.
The aims of this study are: To compare salivary pH changes and stimulation efficacy of two different Gustatory Stimulants of Salivation (GSSS) in patients with Primary Sjögren Syndrome (PSS); To evaluate Primary Sjögren syndrome (PSS) impact and gustatory stimulants of salivary secretion (GSSS) on oral health related quality of life measured by a Portuguese version of Oral Health Impact Profile-14 (OHIP-14) and specific Xerostomia assessment questionnaires.
The Products to be used are the Xeros® Dentaid system and a citric based mouthwash.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Xeros Group - Lozenge | Experimental | Drug: XerosApplication of Xeros system for 15 days. Lozenge (Malic acid 28.56 mg, Xylitol 421,98 mg, Sodium fluoride 0.55 mg) or Spray (Malic acid 1%, Xylitol 10%, Sodium fluoride 0.05%) 4 times a day. Effects on Xerostomia and Quality of Life were determined before and after application by answering the questionnaires. Effects of lozenge on hyposalivation and pH variation determined by saliva collection with pre-weighed falcon and a ph electrode at predetermined times during a 20 minute period. |
| Mouthwash group | Active comparator | Drug: Citric Acid based MouthwashApplication of citric acid based Mouthwash (0,33% citric acid) for 15 days four times a day. Effects on Xerostomia and Quality of Life were determined before and after application by answering the questionnaires. Effects of mouthwash on hyposalivation and pH variation determined by saliva collection with pre-weighed falcon and a pH electrode at predetermined times during a 20 minute period. |
| Xeros Group - Mouthwash | Experimental | Drug: XerosApplication of Xeros system for 15 days. Mouthwash (Betaine 1.33%, Xylitol 3.30%, Sodium fluoride 0.05%, Allantoin 0.10%) 2 times a day. Effects on Xerostomia and Quality of Life were determined before and after application by answering the questionnaires. |
| Xeros Group - Gel | Experimental | Drug: XerosApplication of Xeros system for 15 days. Gel (Betaine 1%, Aloe Vera 0.05%, Xylitol 10%, Sodium Fluoride 0.0033%) before bed. Effects on Xerostomia and Quality of Life were determined before and after application by answering the questionnaires. |
| Xeros Group - Toothpaste | Experimental | Drug: XerosApplication of Xeros system for 15 days. Toothpaste (Betaine 4%, Xylitol 10%, Sodium Fluoride 0.33%, Allantoin 0.10%) 3 times a day. Effects on Xerostomia and Quality of Life were determined before and after application by answering the questionnaires. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- unstimulated whole saliva secretion rate < 0.1 ml/min
- stimulated whole saliva secretion rate > 0.2 ml/min
- above 18 years of age
- Primary Sjogren Syndrome diagnostic according to the European-American Consensus Group
Key exclusion criteria (3 listed)
- wearer of complete dental prosthesis
- those who were pregnant or lactating
- non-speakers of Portuguese.
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 |
|---|---|---|
| Xeros | Drug | Xeros Group - Gel, Xeros Group - Lozenge, Xeros Group - Mouthwash, Xeros Group - Toothpaste |
| Citric Acid based Mouthwash | Drug | Mouthwash group |
Primary outcome
Time of GSSS induced pH drop below 4.5
Time frame: 20 minutes
On the day that the system is attributed the subject is asked to use one of the products and saliva is collected. pH variation is determined at fixed intervals during 20 minutes. Time in which salivary pH is below 4.5 is calculated as well as the number needed to treat and the absolute risk reduction.
Overall and sub domains scores for each questionnaire
Time frame: 15 days
Before and after usage of both products at home, the Summated Xerostomia Inventory-5 (range 0 to 15) to measure subjective feeling of dry mouth, Oral Health Impact Profile-14 (range 0 to 56) to measure quality of life perception related to the oral cavity. This last questionnaire is further divided into 7 subdomains: functional limitation, physical pain, psychological discomfort, physical disability, psychologic disability, social disability and handicap each ranging from 0 to 14. In both questionnaires the total score is the result of the sum of the individual scores in each question. In both questionnaires the higher the score the worse the outcome. The before and after scores obtained are then compared.
1 secondary outcome
Salivary stimulant induced salivary flow
Time frame: 20 minutes
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 6 Jul 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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xeros and Citric Acid based Mouthwash in people with Xerostomia and Hyposalivation, run by Grupo de Investigação em Bioquímica e Biologia Oral.
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 3 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 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Time of GSSS induced pH drop below 4.5 (time frame: 20 minutes). The study lists 2 primary outcomes in all. 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 6 Jul 2018.