XerostomiaNCT05640362
Efficacy of Natural Enzymes Mouthwash: a Randomised Controlled Trial
A study testing Natural enzymes mouthwash and Benzydamine mouthwash in people with Xerostomia and Dry Mouth, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
The goal of this clinical is to assess the efficacy of natural enzymes mouthwash in the treatment of xerostomia (dry mouth). The main questions it aims to answer are: (1) the efficacy of natural enzymes mouthwash in the symptomatic treatment of xerostomia; and (2) the response of xerostomia patients towards natural… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Xerostomia, Dry Mouth
- What is being tested?
- Natural enzymes mouthwash and Benzydamine mouthwash
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteMalaysia
- Study dates
- 10 Nov 2016to 24 Mar 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years old and above,
- complained of dry mouth (xerostomia), and
- taking nutrition orally
Who cannot join
- patients who had been using mouthwash for xerostomia in the past 1 week,
- unable to provide saliva samples,
- unable to chew paraffin wax for stimulated saliva,
- patients with oral motor function deficits, and
- those with severe cognitive deterioration.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Faculty of Dentistry, Universiti Kebangsaan Malaysia
Kuala Lumpur, 50300
About this study
The goal of this clinical is to assess the efficacy of natural enzymes mouthwash in the treatment of xerostomia (dry mouth). The main questions it aims to answer are: (1) the efficacy of natural enzymes mouthwash in the symptomatic treatment of xerostomia; and (2) the response of xerostomia patients towards natural enzymes mouthwash. Participants were given a mouthwash to be used. Intervention group received natural enzymes moisturising mouthwash, while control group received benzydamine mouthwash. Mouthwashes were repacked, labelled with specific code and were given to participants by third-party. Subjects were instructed to rinse with the mouthwash 4 times per day at a specific period, for 2 weeks. Data were compared within each arm before and after using the mouthwashes; and between both arms after using the mouthwashes.
- Conditions
- Xerostomia, Dry Mouth
- Being tested
- Natural enzymes mouthwash, Benzydamine mouthwash
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural enzymes mouthwashOther
Also called Oral7 mouthwash
Natural enzymes mouthwash contains numerous natural protein-enzymes, including lactoferrin, lysozyme, lactoperoxidase, glucose oxidase. These active ingredients were proposed to render this mouthwash to act as salivary substitutes by reinforcing the functions of available saliva, hence reinforcing the immune system in the oral cavity. It was expected to relieve the symptoms in xerostomia patients, and even more if the patients have salivary flow reduction by improving the functions of the limited amount of saliva. The potential mechanisms of action of the mouthwash to treat xerostomia may be related to: (1) lubrication effects to wet the oral mucosal surfaces; (2) antimicrobial properties that will reduce risks of mucosal irritation by infections; (3) absence of alcohol in the mouthwash Subjects were instructed to rinse with the mouthwash 4 times per day at a specific period, for 2 weeks.
Benzydamine mouthwashOther
Also called Difflam mouthwash
Subjects were instructed to rinse with the mouthwash 4 times per day at a specific period, for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Benzydamine mouthwash | Placebo comparator | Not described Receives: Other: Benzydamine mouthwash |
| Natural enzymes mouthwash | Experimental | Not described Receives: Other: Natural enzymes mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in symptoms
Symptoms of xerostomia assessment using Xerostomia Inventory
Measured: At Day 0 and Day 14 of intervention
Secondary outcomes (2)
Changes in clinical signs
Signs of xerostomia assessment using Clinical Oral Dryness Score (CODS)
Measured: At Day 0 and Day 14 of intervention
Salivary flow rate
Resting and stimulated salivary flow rate
Measured: At Day 0 and Day 14 of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start10 Nov 2016
- Primary completion9 Mar 2017
- Study completion24 Mar 2017
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rifqah Nordin, MClinDent, Principal investigator, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640362
- Sponsor's protocol ID
- UKM PPI/111/8/JEP-2016-582
- Status last verified
- Nov 2022
- First submitted
- 28 Nov 2022
- Last updated
- 7 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chiam TL, Choo J, Ashar A, Hussaini HM, Rajandram RK, Nordin R. Efficacy of natural enzymes mouthwash: a randomised controlled trial. Clin Oral Investig. 2024 Apr 19;28(5):259. doi: 10.1007/s00784-024-05658-7.
PubMed 38639763
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Natural Enzymes Mouthwash: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05640362
- Acronym / sponsor ID
- UKM PPI/111/8/JEP-2016-582
- Conditions
- Xerostomia, Dry Mouth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 10 Nov 2016 (actual)
- Primary completion
- 9 Mar 2017 (actual)
- Study completion
- 24 Mar 2017 (actual)
- First posted
- 7 Dec 2022 (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 goal of this clinical is to assess the efficacy of natural enzymes mouthwash in the treatment of xerostomia (dry mouth). The main questions it aims to answer are: (1) the efficacy of natural enzymes mouthwash in the symptomatic treatment of xerostomia; and (2) the response of xerostomia patients towards natural enzymes mouthwash. Participants were given a mouthwash to be used. Intervention group received natural enzymes moisturising mouthwash, while control group received benzydamine mouthwash. Mouthwashes were repacked, labelled with specific code and were given to participants by third-party. Subjects were instructed to rinse with the mouthwash 4 times per day at a specific period, for 2 weeks. Data were compared within each arm before and after using the mouthwashes; and between both arms after using the mouthwashes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Benzydamine mouthwash | Placebo comparator | Other: Benzydamine mouthwash |
| Natural enzymes mouthwash | Experimental | Other: Natural enzymes mouthwash |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years old and above,
- complained of dry mouth (xerostomia), and
- taking nutrition orally
Key exclusion criteria (5 listed)
- patients who had been using mouthwash for xerostomia in the past 1 week,
- unable to provide saliva samples,
- unable to chew paraffin wax for stimulated saliva,
- patients with oral motor function deficits, and
- those with severe cognitive deterioration.
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 |
|---|---|---|
| Natural enzymes mouthwashAlso: Oral7 mouthwashNatural enzymes mouthwash contains numerous natural protein-enzymes, including lactoferrin, lysozyme, lactoperoxidase, glucose oxidase. These active ingredients were proposed to render this mouthwash to act as salivary substitutes by reinforcing the functions of available saliva, hence reinforcing the immune system in the oral cavity. It was expected to relieve the symptoms in xerostomia patients, and even more if the patients have salivary flow reduction by improving the functions of the limited amount of saliva. The potential mechanisms of action of the mouthwash to treat xerostomia may be related to: (1) lubrication effects to wet the oral mucosal surfaces; (2) antimicrobial properties that will reduce risks of mucosal irritation by infections; (3) absence of alcohol in the mouthwash Subjects were instructed to rinse with the mouthwash 4 times per day at a specific period, for 2 weeks. | Other | Natural enzymes mouthwash |
| Benzydamine mouthwashAlso: Difflam mouthwashSubjects were instructed to rinse with the mouthwash 4 times per day at a specific period, for 2 weeks. | Other | Benzydamine mouthwash |
Primary outcome
Changes in symptoms
Time frame: At Day 0 and Day 14 of intervention
Symptoms of xerostomia assessment using Xerostomia Inventory
2 secondary outcomes
Changes in clinical signs
Time frame: At Day 0 and Day 14 of intervention
Salivary flow rate
Time frame: At Day 0 and Day 14 of intervention
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 7 Dec 2022.
- Derived from this study: PubMed 38639763Chiam TL, Choo J, Ashar A, Hussaini HM, Rajandram RK, Nordin R. Efficacy of natural enzymes mouthwash: a randomised controlled trial. Clin Oral Investig. 2024 Apr 19;28(5):259. doi: 10.1007/s00784-024-05658-7.
- Individual participant dataSharing planned: No
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.
Rifqah Nordin, MClinDent principal investigator
National University of Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Natural enzymes mouthwash and Benzydamine mouthwash in people with Xerostomia and Dry Mouth, run by National University of Malaysia at 1 site in Malaysia.
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 3 inclusion and 5 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 7 Dec 2022. 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 Malaysia. 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?
Changes in symptoms (time frame: At Day 0 and Day 14 of 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 NCT05640362, 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 7 Dec 2022.