XerostomiaNCT04323384
The Effect of Biotene® on the Symptoms of Xerostomia and Mastication and Swallowing
A study testing Biotene® Oralbalance Moisturizing Gel in people with Xerostomia and Hyposalivation, run by Nova Scotia Health Authority.
Trial summary
This study will compare the effects of Biotene® Oral Balance Moisturizing Gel (Biotene), an over-the-counter artificial saliva, that the effects of a sham condition on oral health-related quality of life, mastication, and swallowing in four groups of participants: 1) Participants not experiencing xerostomia or… Read more about this study
- Who is it for?
- Ages 19 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Xerostomia, Hyposalivation
- What is being tested?
- Biotene® Oralbalance Moisturizing Gel
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 1 Dec 2021
- 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 19 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Medically stable adults
- Age 19 years of age or older
- Able to sit upright independently and transfer to a chair
- Able to eat foods requiring mastication
- Decision-making capacity to provide informed consent
Who cannot join
- Acute illness or uncontrolled medical condition
- Allergies to any pharmaceuticals
- Allergies to medical tape/adhesive
- Allergies to Nabisco Saltines® or any of the ingredients
- Participant-reported issues with excess saliva and/or drooling
- Open ulcerations in the oral cavity.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Biotene® Oralbalance Moisturizing Gel on the Symptoms of Xerostomia and the Efficiency and Ease of Mastication and Swallowing
This study will compare the effects of Biotene® Oral Balance Moisturizing Gel (Biotene), an over-the-counter artificial saliva, that the effects of a sham condition on oral health-related quality of life, mastication, and swallowing in four groups of participants: 1) Participants not experiencing xerostomia or hyposalivation, 2) Participants experiencing xerostomia and hyposalivation, 3) Participants experiencing xerostomia but not hyposalivation, 4) Participants experiencing hyposalivation but not xerostomia.
Read the detailed description
Saliva is important for maintaining oral and general health. This complex bioactive substance serves many functions including i) protecting the oral mucosa, ii) reducing demineralization and facilitating remineralization of teeth, and iii) sustaining a balanced oral biome and facilitating antimicrobial actions and clearance of pathogens. Moreover, saliva also plays a critical role in alimentary functions such as mastication and swallowing.
The role of saliva in the process of mastication and swallowing is complex and is not currently well understood. The purpose of mastication is to process food in the oral cavity into a bolus that can be transported through the oropharynx, swallowed safely, and then easily digested. During mastication, ingested food particles are mechanically reduced in size through the process of lingual particle selection and fragmentation between the occlusal surfaces of the teeth. The secretion of saliva is critical for effective mastication, bolus formation and bolus transport. There is also evidence to suggest that the volume of saliva secreted into the oral cavity during alimentation may impact swallowing biomechanics.
Oral tissue dryness is a complex issue. Hyposalivation and xerostomia span numerous clinical pathologies and are known side effects of many therapeutic agents. Hyposalivation occurs when there are objective signs of a reduction of the amount of saliva produced by the salivary glands and can be measured using sialometry. Xerostomia refers to the subjective symptoms of dry mouth and can only be assessed through a person's perception of the presence of symptoms. A person may experience xerostomia with or without hyposalivation or experience hyposalivation with or without xerostomia. Hyposalivation is a commonly complaint in older adults. Additionally, patients with hyposalivation and xerostomia frequently report symptoms of dysphagia, or difficulty swallowing.
To alleviate symptoms associated with hyposalivation, such as the perception of dry mouth, or xerostomia, many people use over-the-counter artificial saliva products such as Biotene® Oral Balance Moisturizing Gel (Biotene). There is, however, a paucity of evidence examining the effect of these products on oral health-related quality of life, mastication, and swallowing. The goal of this study therefore, is to compare the effects of Biotene® Oral Balance Moisturizing Gel (Biotene) with the effects of a sham condition on oral health-related quality of life, masticatory efficiency, and perceived swallowing effort in four groups of participants: 1) Participants not experiencing xerostomia or hyposalivation, 2) Participants experiencing xerostomia and hyposalivation, 3) Participants experiencing xerostomia but not hyposalivation, 4) Participants experiencing hyposalivation but not xerostomia.
It is hypothesized that, following the application of Biotene® Oralbalance Moisturizing Gel, all groups of participants will experience improved oral health-related quality of life, improved masticatory efficiency a reduction in perceived swallowing effort. The reduction will be significant when compared with that of the sham condition. Participants with xerostomia and/or hyposalivation will demonstrate greater improvement in oral health-related quality of life, improvement in masticatory efficiency, and reduction in perceived swallowing effort compared with those who do not experience xerostomia and/or hyposalivation.
- Conditions
- Xerostomia, Hyposalivation
- Being tested
- Biotene® Oralbalance Moisturizing Gel
- Keywords
- swallowing, saliva, oral health, mastication, quality of life, artificial saliva
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biotene® Oralbalance Moisturizing GelDevice
Biotene® Oralbalance Moisturizing Gel will be applied to the oral cavity according to the package directions.
| Study group | Role | What they receive |
|---|---|---|
| Biotene® followed by Sham | Experimental | Recruited volunteers will each participate in two experimental sessions. Participants will be randomized into either Protocol A or Protocol B. In their first session, participants in Protocol A will undergo baseline mastication, swallowing, salivary, and oral health-related quality of life testing, then they will receive the experimental condition. For the experimental condition, participants will be instructed to apply Biotene® Oralbalance Moisturizing Gel according to package directions. Testing will then be repeated. In the second session, after baseline testing, participants will receive the sham condition (instead of the experimental condition). For the sham condition, participants will be instructed to rinse their mouth with room temperature distilled water. Testing will then be repeated. Receives: Device: Biotene® Oralbalance Moisturizing Gel |
| Sham followed by Biotene® | Experimental | Recruited volunteers will each participate in two experimental sessions. Participants will be randomized into two protocols: 1) Protocol A and 2) Protocol B. In their first session, participants in Protocol B will undergo baseline mastication, swallowing, salivary, and oral health-related quality of life testing, then they will receive the sham condition. Testing will then be repeated. In the second session, after baseline testing, participants will receive the experimental condition (instead of the sham condition). Testing will then be repeated. Receives: Device: Biotene® Oralbalance Moisturizing Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Perceived Swallowing Effort after application of Biotene®/Sham
Participants will be instructed to swallow and use a visual analog scale to rate the perceived swallowing effort by bisecting a 100mm line anchored with "no effort" and "extreme effort" (higher scores indicate a worse outcome). After the experimental or sham condition has been applied, participants will re-rate their perceived swallowing effort.
Measured: baseline, after application of Biotene®/sham
Secondary outcomes (4)
Change in Spontaneous Swallowing Frequency after application of Biotene®/Sham
Spontaneous swallowing frequency will be derived from four physiologic signals. These include, simultaneous respiratory movements (swallowing apnea), surface movements associated with hyolaryngeal excursion recorded via a pressure pad transducer, and acoustic signals associated with hyolaryngeal excursion obtained using a contact microphone adhered to the skin just below the lateral cricoid cartilage, and event marking using an independent rater.
Measured: baseline, after application of the Biotene®/sham
Change in the Test of Masticating and Swallowing Solids (TOMASS) after application of Biotene®/Sham
The TOMASS will be used to evaluate masticatory efficiency. Participants will be instructed to eat a single portion of a cracker "as quickly as is comfortably possible and when you have finished, say your name out loud". Two independent raters will observe a lateral view of the face and count masticatory cycles by observing jaw movements. Timing of the entire task will be recorded using a stopwatch. Longer mastication times/more masticatory cycles required to eat the cracker are a worse outcomes.
Measured: baseline, after application of the Biotene®/sham
Change in the Effectiveness of Mastication and Swallowing after application of Biotene®/Sham
Effectiveness of mastication and swallowing will be measured based on cleansability of debris in the oral cavity. Pictures of the oral cavity will be taken before and after chewing the cracker and a score will be assigned based on the amount of residual cracker in the oral cavity. The criteria used to assign a rating (0-2) will be based on the Oral Health Assessment Tool (OHAT). Higher values indicate worse outcomes.
Measured: baseline, after application of the Biotene®/sham
Change in Oral Health-Related Quality of Life after application of the Biotene®/sham
A combination of the Oral Health Quality of Life Inventory (OH-QoL) survey and the Eight-item Visual Analogue Scale (VAS) xerostomia questionnaire will be used to measure oral health-related quality of life. Questions from the OH-QoL specific to moisture will be administered and participants will rate their responses on a likert scale (1=somewhat important; 2=very important), and to understand the effect Biotene® Oralbalance Moisturizing Gel on oral health quality of life, "How happy are you with how moist your mouth feels?" will be asked before and after the application of Biotene® Oralbalance Moisturizing Gel or the sham. The eight-item VAS xerostomia questionnaire will also be administered asked before and after the application of Biotene® Oralbalance Moisturizing Gel or the sham (higher scores indicate worse outcomes).
Measured: baseline, after application of the Biotene®/sham condition, half hour increments until responses revert to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start1 Sep 2020 (estimated)
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
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.
- More trials run by Nova Scotia Health AuthorityThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This project will use a crossover, repeated measures design to test the previously stated hypotheses. The benefits of using this design include improved control of between-subject variability and improved statistical power.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Dalhousie University
- Responsible party
- Principal investigator, Rebecca, Nova Scotia Health Authority
- Investigators
- Leigha Rock, PhD, Principal investigator, Nova Scotia Health Authority/Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04323384
- Sponsor's protocol ID
- 23677
- Status last verified
- Mar 2020
- First submitted
- 23 Mar 2020
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Biotene® Oralbalance Moisturizing Gel on the Symptoms of Xerostomia and the Efficiency and Ease of Mastication and Swallowing
- ClinicalTrials.gov ID
- NCT04323384
- Acronym / sponsor ID
- 23677
- Conditions
- Xerostomia, Hyposalivation
- Keywords
- swallowing, saliva, oral health, mastication, quality of life, artificial saliva
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- Dalhousie University
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 26 Mar 2020 (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.
This study will compare the effects of Biotene® Oral Balance Moisturizing Gel (Biotene), an over-the-counter artificial saliva, that the effects of a sham condition on oral health-related quality of life, mastication, and swallowing in four groups of participants: 1) Participants not experiencing xerostomia or hyposalivation, 2) Participants experiencing xerostomia and hyposalivation, 3) Participants experiencing xerostomia but not hyposalivation, 4) Participants experiencing hyposalivation but not xerostomia.
Detailed description
Saliva is important for maintaining oral and general health. This complex bioactive substance serves many functions including i) protecting the oral mucosa, ii) reducing demineralization and facilitating remineralization of teeth, and iii) sustaining a balanced oral biome and facilitating antimicrobial actions and clearance of pathogens. Moreover, saliva also plays a critical role in alimentary functions such as mastication and swallowing.
The role of saliva in the process of mastication and swallowing is complex and is not currently well understood. The purpose of mastication is to process food in the oral cavity into a bolus that can be transported through the oropharynx, swallowed safely, and then easily digested. During mastication, ingested food particles are mechanically reduced in size through the process of lingual particle selection and fragmentation between the occlusal surfaces of the teeth. The secretion of saliva is critical for effective mastication, bolus formation and bolus transport. There is also evidence to suggest that the volume of saliva secreted into the oral cavity during alimentation may impact swallowing biomechanics.
Oral tissue dryness is a complex issue. Hyposalivation and xerostomia span numerous clinical pathologies and are known side effects of many therapeutic agents. Hyposalivation occurs when there are objective signs of a reduction of the amount of saliva produced by the salivary glands and can be measured using sialometry. Xerostomia refers to the subjective symptoms of dry mouth and can only be assessed through a person's perception of the presence of symptoms. A person may experience xerostomia with or without hyposalivation or experience hyposalivation with or without xerostomia. Hyposalivation is a commonly complaint in older adults. Additionally, patients with hyposalivation and xerostomia frequently report symptoms of dysphagia, or difficulty swallowing.
To alleviate symptoms associated with hyposalivation, such as the perception of dry mouth, or xerostomia, many people use over-the-counter artificial saliva products such as Biotene® Oral Balance Moisturizing Gel (Biotene). There is, however, a paucity of evidence examining the effect of these products on oral health-related quality of life, mastication, and swallowing. The goal of this study therefore, is to compare the effects of Biotene® Oral Balance Moisturizing Gel (Biotene) with the effects of a sham condition on oral health-related quality of life, masticatory efficiency, and perceived swallowing effort in four groups of participants: 1) Participants not experiencing xerostomia or hyposalivation, 2) Participants experiencing xerostomia and hyposalivation, 3) Participants experiencing xerostomia but not hyposalivation, 4) Participants experiencing hyposalivation but not xerostomia.
It is hypothesized that, following the application of Biotene® Oralbalance Moisturizing Gel, all groups of participants will experience improved oral health-related quality of life, improved masticatory efficiency a reduction in perceived swallowing effort. The reduction will be significant when compared with that of the sham condition. Participants with xerostomia and/or hyposalivation will demonstrate greater improvement in oral health-related quality of life, improvement in masticatory efficiency, and reduction in perceived swallowing effort compared with those who do not experience xerostomia and/or hyposalivation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This project will use a crossover, repeated measures design to test the previously stated hypotheses. The benefits of using this design include improved control of between-subject variability and improved statistical power.
| Arm | Type | Receives |
|---|---|---|
| Biotene® followed by Sham | Experimental | Device: Biotene® Oralbalance Moisturizing GelRecruited volunteers will each participate in two experimental sessions. Participants will be randomized into either Protocol A or Protocol B. In their first session, participants in Protocol A will undergo baseline mastication, swallowing, salivary, and oral health-related quality of life testing, then they will receive the experimental condition. For the experimental condition, participants will be instructed to apply Biotene® Oralbalance Moisturizing Gel according to package directions. Testing will then be repeated. In the second session, after baseline testing, participants will receive the sham condition (instead of the experimental condition). For the sham condition, participants will be instructed to rinse their mouth with room temperature distilled water. Testing will then be repeated. |
| Sham followed by Biotene® | Experimental | Device: Biotene® Oralbalance Moisturizing GelRecruited volunteers will each participate in two experimental sessions. Participants will be randomized into two protocols: 1) Protocol A and 2) Protocol B. In their first session, participants in Protocol B will undergo baseline mastication, swallowing, salivary, and oral health-related quality of life testing, then they will receive the sham condition. Testing will then be repeated. In the second session, after baseline testing, participants will receive the experimental condition (instead of the sham condition). Testing will then be repeated. |
Who may qualify
- Ages
- 19 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Medically stable adults
- Age 19 years of age or older
- Able to sit upright independently and transfer to a chair
- Able to eat foods requiring mastication
- Decision-making capacity to provide informed consent
Key exclusion criteria (6 listed)
- Acute illness or uncontrolled medical condition
- Allergies to any pharmaceuticals
- Allergies to medical tape/adhesive
- Allergies to Nabisco Saltines® or any of the ingredients
- Participant-reported issues with excess saliva and/or drooling
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 |
|---|---|---|
| Biotene® Oralbalance Moisturizing GelBiotene® Oralbalance Moisturizing Gel will be applied to the oral cavity according to the package directions. | Device | Biotene® followed by Sham, Sham followed by Biotene® |
Primary outcome
Change in Perceived Swallowing Effort after application of Biotene®/Sham
Time frame: baseline, after application of Biotene®/sham
Participants will be instructed to swallow and use a visual analog scale to rate the perceived swallowing effort by bisecting a 100mm line anchored with "no effort" and "extreme effort" (higher scores indicate a worse outcome). After the experimental or sham condition has been applied, participants will re-rate their perceived swallowing effort.
4 secondary outcomes
Change in Spontaneous Swallowing Frequency after application of Biotene®/Sham
Time frame: baseline, after application of the Biotene®/sham
Change in the Test of Masticating and Swallowing Solids (TOMASS) after application of Biotene®/Sham
Time frame: baseline, after application of the Biotene®/sham
Change in the Effectiveness of Mastication and Swallowing after application of Biotene®/Sham
Time frame: baseline, after application of the Biotene®/sham
Change in Oral Health-Related Quality of Life after application of the Biotene®/sham
Time frame: baseline, after application of the Biotene®/sham condition, half hour increments until responses revert to baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Leigha Rock, PhD principal investigator
Nova Scotia Health Authority/Dalhousie University
Questions about this trial
What is this clinical trial studying?
A study testing Biotene® Oralbalance Moisturizing Gel in people with Xerostomia and Hyposalivation, run by Nova Scotia Health Authority.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 26 Mar 2020. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leigha Rock, PhD (902.494.8864, leigha.rock@dal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Perceived Swallowing Effort after application of Biotene®/Sham (time frame: baseline, after application of Biotene®/sham). 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 26 Mar 2020.