XerostomiaNCT01627626
Effect of 0.1% Pilocarpine Mouthwash on Xerostomia
A study testing Pilocarpine and saline in people with Xerostomia, run by Jeong-seong Kwon at 1 site in South Korea.
Trial summary
The aim of this study is to evaluate the effect of 0.1% pilocarpine mouthwash on subjective dryness, minor salivary flow rates and unstimulated whole salivary flow rate in xerostomic patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Xerostomia
- What is being tested?
- Pilocarpine and saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2011to Mar 2012
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- xerostomia for 3 months or more, and
- adults aged 20 years and older.
Who cannot join
- acute asthma attack
- acute iritis
- narrow angle glaucoma
- pilocarpine allergy
- pregnancy
- lactating women, and
- person who was treating xerostomia with artificial saliva, pilocarpine, or etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of 0.1% Pilocarpine Mouthwash on Xerostomia : Double-blind, Randomized Controlled Trial
The aim of this study is to evaluate the effect of 0.1% pilocarpine mouthwash on subjective dryness, minor salivary flow rates and unstimulated whole salivary flow rate in xerostomic patients.
- Conditions
- Xerostomia
- Being tested
- Pilocarpine, saline
- Keywords
- xerostomia, pilocarpine mouthwash, minor salivary gland secretion
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PilocarpineDrug
0.1% pilocarpine solution which diluted 2% pilocarpine hydrochloride eyedrop with 0.9% saline.
subjects were instructed to mouthwash with 10ml of solution for 1 minute.
salineDrug
0.9% saline solution
| Study group | Role | What they receive |
|---|---|---|
| 0.1% pilocarpine mouthwash | Experimental | 0.1% pilocarpine solution which diluted 2% pilocarpine hydrochloride eyedrop with 0.9% saline Receives: Drug: Pilocarpine |
| 0.9% saline mouthwash | Placebo comparator | 0.9% saline as a mouthwash Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in minor salivary flow rates at 60 minutes
Minor salivary flow rates (from buccal, lower labial and palatal mucosa) were measured before and after using the mouthwash at predetermined times: baseline, immediately (0 min), and 30 and 60 minutes after. The Periotron 8000 device (Oraflow, New York, USA)was used to measure the flow rate (µl/cm2 per min) of saliva from the minor glands, in accordance with the method of Eliasson et al. (1996).
Measured: before and after using the mouthwash (baseline, immediately, 30 minutes, 60 minutes)
Secondary outcomes (3)
Change from baseline in the severity of oral dryness at 60 minutes
The severity of oral dryness was measured on a numerical rating scale (NRS ; 0-10, where 0=no dry mouth and 10=the worst dry mouth imaginable) before and after using the mouthwash at predetermined times: baseline, immediately (0 min), and 30 and 60 minutes after.
Measured: Before and after using mouthwash (baseline, immediately, 30 minutes, 60 minutes)
Change from baseline in the unstimulated whole salivary flow rates at 60 minutes
Unstimulated whole salivary flow rates (ml/min) were measured before and after using the mouthwash at predetermined times: baseline, and 60 minutes after. Unstimulated whole saliva was collected via the spitting method for 10 minutes while the subject was sitting in an upright position with the head slightly tilted forward and the eyes open after resting for 5 minutes. Subjects were instructed to minimize their orofacial movements during measurement.
Measured: Before and after using mouthwash (baseline, 60 minutes)
Change from baseline in the severity of oral dryness, minor salivary flow rates, and the unstimulated whole saliva flow rate at 4 weeks
The severity of oral dryness, minor salivary flow rates, and the unstimulated whole salivary flow rates were measured after using the prescribed mouthwash regularly (with 10 ml of the solution for 1 minute, three times per day) for 4 weeks.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2012 (estimated)
- Study startAug 2011
- Primary completionOct 2011
- Study completionMar 2012
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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeong-seong Kwon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jeong-seong Kwon, Yonsei University
- Investigators
- Jeong-Seung Kwon, DDS,MSD,PhD, Principal investigator, Yonsei University Dental Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01627626
- Sponsor's protocol ID
- 2-2011-0032
- Status last verified
- Jun 2012
- First submitted
- 13 Jun 2012
- Last updated
- 26 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 0.1% Pilocarpine Mouthwash on Xerostomia : Double-blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01627626
- Acronym / sponsor ID
- 2-2011-0032
- Conditions
- Xerostomia
- Keywords
- xerostomia, pilocarpine mouthwash, minor salivary gland secretion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Jeong-seong KwonUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 26 Jun 2012 (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.
The aim of this study is to evaluate the effect of 0.1% pilocarpine mouthwash on subjective dryness, minor salivary flow rates and unstimulated whole salivary flow rate in xerostomic patients.
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 |
|---|---|---|
| 0.1% pilocarpine mouthwash | Experimental | Drug: Pilocarpine0.1% pilocarpine solution which diluted 2% pilocarpine hydrochloride eyedrop with 0.9% saline |
| 0.9% saline mouthwash | Placebo comparator | Drug: saline0.9% saline as a mouthwash |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- xerostomia for 3 months or more, and
- adults aged 20 years and older.
Key exclusion criteria (7 listed)
- acute asthma attack
- acute iritis
- narrow angle glaucoma
- pilocarpine allergy
- pregnancy
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 |
|---|---|---|
| Pilocarpine0.1% pilocarpine solution which diluted 2% pilocarpine hydrochloride eyedrop with 0.9% saline. subjects were instructed to mouthwash with 10ml of solution for 1 minute. | Drug | 0.1% pilocarpine mouthwash |
| saline0.9% saline solution | Drug | 0.9% saline mouthwash |
Primary outcome
Change from baseline in minor salivary flow rates at 60 minutes
Time frame: before and after using the mouthwash (baseline, immediately, 30 minutes, 60 minutes)
Minor salivary flow rates (from buccal, lower labial and palatal mucosa) were measured before and after using the mouthwash at predetermined times: baseline, immediately (0 min), and 30 and 60 minutes after. The Periotron 8000 device (Oraflow, New York, USA)was used to measure the flow rate (µl/cm2 per min) of saliva from the minor glands, in accordance with the method of Eliasson et al. (1996).
3 secondary outcomes
Change from baseline in the severity of oral dryness at 60 minutes
Time frame: Before and after using mouthwash (baseline, immediately, 30 minutes, 60 minutes)
Change from baseline in the unstimulated whole salivary flow rates at 60 minutes
Time frame: Before and after using mouthwash (baseline, 60 minutes)
Change from baseline in the severity of oral dryness, minor salivary flow rates, and the unstimulated whole saliva flow rate at 4 weeks
Time frame: 4 weeks
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 26 Jun 2012.
Related trials for Xerostomia
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
Recruiting
Evaluation of the Prevalence, and Immunological Characteristics of Small Fiber Neuropathy in Patients With Primary Sjögren's Syndrome
Sjögren's Syndrome, Small Fiber Neuropathy
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.
Jeong-Seung Kwon, DDS,MSD,PhD principal investigator
Yonsei University Dental Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilocarpine and saline in people with Xerostomia, run by Jeong-seong Kwon at 1 site in South Korea.
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 7 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 26 Jun 2012. 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 South Korea. 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?
Change from baseline in minor salivary flow rates at 60 minutes (time frame: before and after using the mouthwash (baseline, immediately, 30 minutes, 60 minutes)). 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 Jun 2012.