XerostomiaNCT02317172
Efficacy of Novel Edible Gel-based Artificial Saliva in Thai Geriatric Populations With Systemic Diseases
A study testing Gel-based artificial saliva in people with Xerostomia and Hypertension, run by Dental Innovation Foundation Under Royal Patronage at 1 site in Thailand.
Trial summary
Elderly people usually have systemic diseases and take medications that can cause dry mouth. The purpose of this study is to determine whether continuous use of edible, gel-based artificial saliva in geriatric population with dry mouth problems will reduce signs and symptoms of dry mouth and improve quality of… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Xerostomia, Hypertension, Diabetes Mellitus
- What is being tested?
- Gel-based artificial saliva
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2012to Mar 2013
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have systemic diseases such as hypertension or diabetes mellitus and take medications that can cause dry mouth
- Report symptoms of dry mouth
Who cannot join
- Subjects with uncontrolled systemic diseases
- Subjects who aspirate upon eating
- Subjects who smoke
- Subjects who are allergic to component of the intervention
Trial locations and contacts
1 site in 1 country.
About this study
Elderly people usually have systemic diseases and take medications that can cause dry mouth. The purpose of this study is to determine whether continuous use of edible, gel-based artificial saliva in geriatric population with dry mouth problems will reduce signs and symptoms of dry mouth and improve quality of patients' saliva.
Read the detailed description
A pre-post test trial was conducted in 120 elders with xerostomia. All subjects received a total of 50 ml (10ml x 5 times) OMJ per day. Subjective and objective dry mouth scores, salivary pH, buffering capacity and satisfaction were monitored at 2 weeks and 1 month use, compared to baseline. The data were analyzed by Repeated Measure ANOVA.
- Conditions
- Xerostomia, Hypertension, Diabetes Mellitus
- Being tested
- Gel-based artificial saliva
- Keywords
- Saliva substitute, Edible gel, Xerostomia, Diabetes Mellitus, Hypertension
- Medical subject headings
- Xerostomia, Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gel-based artificial salivaOther
Also called Oral moisturizing jelly
Gel-based artificial saliva is a novel gel-like, edible moisturizing gel designed to relieve dry mouth.
| Study group | Role | What they receive |
|---|---|---|
| Gel-based artificial saliva | Experimental | Continuous oral intake of edible gel-based artificial saliva (30-50 ml/day) for four weeks Receives: Other: Gel-based artificial saliva |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in subjective dry mouth score
The outcome measure (subjective dry mouth score) will be measured before and 2 and 4 weeks after continuous usage of edible gel-based artificial saliva (30-50 ml/day for at least 5 days per week)
Measured: baseline, 2 weeks and 4 weeks after intervention
Secondary outcomes (4)
Changes in objective dry mouth score
The outcome measure will be measured before and 2 and 4 weeks after continuous usage of edible gel-based artificial saliva (30-50 ml/day for at least 5 days per week)
Measured: baseline, 2 weeks and 4 weeks after intervention
Changes in salivary Potential of Hydrogen ion (pH)
The outcome measure will be measured before and 2 and 4 weeks after continuous usage of edible gel-based artificial saliva (30-50 ml/day for at least 5 days per week)
Measured: baseline, 2 weeks and 4 weeks after intervention
Changes in salivary buffering capacity
The outcome measure will be measured before and 2 and 4 weeks after continuous usage of edible gel-based artificial saliva (30-50 ml/day for at least 5 days per week)
Measured: baseline, 2 weeks and 4 weeks after intervention
Satisfaction of the edible gel-based artificial saliva
All subjects will try a few spoon of the edible gel based saliva and a commercially available inedible gel-based saliva. Then, all subjects will be interviewed for satisfaction of both products and compare the results.
Measured: at the first day of trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2014 (estimated)
- Study startOct 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dental Innovation Foundation Under Royal Patronage
- Sponsor type
- University, hospital or other
- Collaborators
- Thammasat University, Srinakharinwirot University, Mahidol University, Ministry of Health, Thailand
- Responsible party
- Sponsor
- Investigators
- Aroonwan Lam-ubol, DDS, PhD, Principal investigator, Srinakharinwirot University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02317172
- Sponsor's protocol ID
- DIF-03
- Status last verified
- Dec 2014
- First submitted
- 11 Dec 2014
- Last updated
- 15 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Dalodom S, Lam-Ubol A, Jeanmaneechotechai S, Takamfoo L, Intachai W, Duangchada K, Hongsachum B, Kanjanatiwat P, Vacharotayangul P, Trachootham D. Influence of oral moisturizing jelly as a saliva substitute for the relief of xerostomia in elderly patients with hypertension and diabetes mellitus. Geriatr Nurs. 2016 Mar-Apr;37(2):101-9. doi: 10.1016/j.gerinurse.2015.10.014. Epub 2015 Nov 26.
PubMed 26631691
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Novel Edible Gel-based Artificial Saliva in Thai Geriatric Populations With Systemic Diseases
- ClinicalTrials.gov ID
- NCT02317172
- Acronym / sponsor ID
- DIF-03
- Conditions
- Xerostomia, Hypertension, Diabetes Mellitus
- Keywords
- Saliva substitute, Edible gel, Xerostomia, Diabetes Mellitus, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Dental Innovation Foundation Under Royal PatronageUniversity, hospital or other
- Collaborators
- Thammasat University, Srinakharinwirot University, Mahidol University, Ministry of Health, Thailand
- Study start
- Oct 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 15 Dec 2014 (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.
Elderly people usually have systemic diseases and take medications that can cause dry mouth. The purpose of this study is to determine whether continuous use of edible, gel-based artificial saliva in geriatric population with dry mouth problems will reduce signs and symptoms of dry mouth and improve quality of patients' saliva.
Detailed description
A pre-post test trial was conducted in 120 elders with xerostomia. All subjects received a total of 50 ml (10ml x 5 times) OMJ per day. Subjective and objective dry mouth scores, salivary pH, buffering capacity and satisfaction were monitored at 2 weeks and 1 month use, compared to baseline. The data were analyzed by Repeated Measure ANOVA.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gel-based artificial saliva | Experimental | Other: Gel-based artificial salivaContinuous oral intake of edible gel-based artificial saliva (30-50 ml/day) for four weeks |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have systemic diseases such as hypertension or diabetes mellitus and take medications that can cause dry mouth
- Report symptoms of dry mouth
Key exclusion criteria (4 listed)
- Subjects with uncontrolled systemic diseases
- Subjects who aspirate upon eating
- Subjects who smoke
- Subjects who are allergic to component of the intervention
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 |
|---|---|---|
| Gel-based artificial salivaAlso: Oral moisturizing jellyGel-based artificial saliva is a novel gel-like, edible moisturizing gel designed to relieve dry mouth. | Other | Gel-based artificial saliva |
Primary outcome
Changes in subjective dry mouth score
Time frame: baseline, 2 weeks and 4 weeks after intervention
The outcome measure (subjective dry mouth score) will be measured before and 2 and 4 weeks after continuous usage of edible gel-based artificial saliva (30-50 ml/day for at least 5 days per week)
4 secondary outcomes
Changes in objective dry mouth score
Time frame: baseline, 2 weeks and 4 weeks after intervention
Changes in salivary Potential of Hydrogen ion (pH)
Time frame: baseline, 2 weeks and 4 weeks after intervention
Changes in salivary buffering capacity
Time frame: baseline, 2 weeks and 4 weeks after intervention
Satisfaction of the edible gel-based artificial saliva
Time frame: at the first day of trial
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 15 Dec 2014.
- Derived from this study: PubMed 26631691Dalodom S, Lam-Ubol A, Jeanmaneechotechai S, Takamfoo L, Intachai W, Duangchada K, Hongsachum B, Kanjanatiwat P, Vacharotayangul P, Trachootham D. Influence of oral moisturizing jelly as a saliva substitute for the relief of xerostomia in elderly patients with hypertension and diabetes mellitus. Geriatr Nurs. 2016 Mar-Apr;37(2):101-9. doi: 10.1016/j.gerinurse.2015.10.014. Epub 2015 Nov 26.
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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.
Aroonwan Lam-ubol, DDS, PhD principal investigator
Srinakharinwirot University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gel-based artificial saliva in people with Xerostomia and Hypertension, run by Dental Innovation Foundation Under Royal Patronage at 1 site in Thailand.
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 2 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 15 Dec 2014. 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 Thailand. 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.
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?
Changes in subjective dry mouth score (time frame: baseline, 2 weeks and 4 weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02317172, which also lists 1 linked publication.
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 15 Dec 2014.