Dry MouthNCT06240806
Efficacy of Manuka Honey Oral Rinse in Treatment of Xerostomia
A study testing Manuka Honey and Saline mouthwash in people with Dry Mouth and Salivary Gland Diseases, run by British University In Egypt at 1 site in Egypt.
Trial summary
Xerostomia causes many clinical problems, including oral infections, speech difficulties, and impaired chewing and swallowing of food thus may affect the individual's quality of life, therefore this study aimed to evaluate the clinical effectiveness of Manuka honey mouth rinse using the subjective dry mouth score, and… Read more about this study
- Who is it for?
- Ages 66 years and older
- Conditions the study is for
- Dry Mouth, Salivary Gland Diseases
- What is being tested?
- Manuka Honey and Saline mouthwash
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2023to 10 Jan 2024
- 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 66 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- - Both genders, aged above 65 years.
- All patients must have complaint of xerostomia.
- Patients must be able to make reliable decision or communications.
Who cannot join
- - Smoking, Alcohol.
- Patient with history of any serious illness as malignancy.
- Patients with any autoimmune disease.
- Vulnerable groups such as pregnant females, prisoners, mentally and physically handicapped individuals.
- Known hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Manuka Honey Oral Rinse in Treatment of Xerostomia in Elderly: A Randomized Controlled Clinical Trial
Xerostomia causes many clinical problems, including oral infections, speech difficulties, and impaired chewing and swallowing of food thus may affect the individual's quality of life, therefore this study aimed to evaluate the clinical effectiveness of Manuka honey mouth rinse using the subjective dry mouth score, and patient satisfaction as primary objectives and to assess the effect of Manuka honey on the salivary flow rate, and objective dry mouth score as secondary objectives.
Read the detailed description
Xerostomia has a variety of possible etiological factors; it is generally classified as having primary and secondary causes. Primary causes comprise conditions that directly affect the salivary glands and induce xerostomia like, Sjogren's syndrome, diabetes mellitus type 1 and 2, thyroid disease, adrenal pathology, renal or hepatic diseases, hepatitis C virus infection, and HIV disease.
Secondary causes of xerostomia include the side-effects of radiation therapy or chemotherapy, rheumatoid arthritis, scleroderma, mixed connective tissues diseases, systemic lupus erythematous, graft versus host disease, anorexia, alcohol and smoking and commonly prescribed drugs (>500 medications reportedly cause dry mouth). The most common medications causing hyposalivation are those with anticholinergic activity, sympathomimetic, and benzodiazepines. The risk of xerostomia increases with the synergistic effects of xerogenic medications, multiple medications, higher doses of medication, and the duration of the medication.
Honey was found to have several benefits as an alternative medicine, it has been used as a natural medicine for more than 2000 years, mainly for wound healing. Though there are many varieties of honey, only some of them e.g. Manuka honey and Malaysian Tualang honey, have been studied in detail for their medicinal properties.
Manuka honey is a monofloral honey, produced from the nectar of flowers of Manuka tree. This variety is produced from the Apis mellifera honey bees, using New Zealand Manuka plants producing specific floral-variety named as Leptospermum scoparium. The composition of Manuka honey consists of carbohydrates, minerals, proteins, fatty acids, phenolic and flavonoid compounds. Although such compounds are found in other types of honey, other unique features also occur in Manuka honey, such as an unusually high level of methylglyoxal (MGO) formed from dihydroxyacetone (DHA) which correlates with antibacterial activity.Manuka honey shows antioxidant and anticancer properties, which are considered due to its constituents-phytochemicals working as active bio-compounds.
- Conditions
- Dry Mouth, Salivary Gland Diseases
- Being tested
- Manuka Honey, Saline mouthwash
- Medical subject headings
- Xerostomia, Salivary Gland Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manuka HoneyOther
Manuka honey will be topically applied to the oral mucosa as oral rinse based on the Biswal et al., 2003 administration protocol.
Saline mouthwashOther
Saline mouthwash will be used 3 times per day for one month
| Study group | Role | What they receive |
|---|---|---|
| Manuka honey interventional arm | Active comparator | Manuka honey used as mouth rinse in treatment of xerostomia Receives: Other: Manuka Honey |
| Saline mouthwash control group | Placebo comparator | Saline used as mouth rinse for xerostomia Receives: Other: Saline mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in subjective dry mouth score
changes in subjective dry mouth score [Time frame: baseline, 2 weeks, and 4 weeks] after manuka honey mouth rinse use higher number scores mean worse diagnosis while lower values mean better prognosis
Measured: one month
Secondary outcomes (3)
Changes in objective dry mouth score
changes in objective dry mouth score [Time frame: baseline, 2 weeks, and 4 weeks] after manuka honey mouth rinse use higher number scores mean worse diagnosis while lower values mean better prognosis
Measured: one month
Increase in Unstimulated Salivary flow rate (ml/min)
Eating and talking were prohibited during the time of collection. Unstimulated whole saliva was collected for 5 min by spitting method. The collection will be timed, so that flow rate (mL/min) could be measured As the salivary flow rates increased it means improvement
Measured: one month
Changes in salivary potential of hydrogen ion (pH)
following saliva collection, pH was measured immediately using the narrow-range pH strip system (Merck). One drop of the collected saliva was placed on the test strip and its color change reflected the pH of the saliva.
As salivary pH increased it means improvement
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start1 Dec 2023
- Primary completion15 Dec 2023
- Study completion10 Jan 2024
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 Dry MouthStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The experimental group will use a 20ml of (Manuka honey) in 100 ml purified water as mouthwash three times a day (preferably after their meals), kept it for one minute, and then poured it out . the control arm followed the same protocol with normal saline rinses in the same opaque bottles 3 times per day.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240806
- Sponsor's protocol ID
- 23-061
- Status last verified
- Jan 2024
- First submitted
- 14 Jan 2024
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ghalwash D, El-Gawish A, Abou-Bakr A. Efficacy of Manuka honey oral rinse in treatment of xerostomia among elderly patients: a randomized controlled trial. BMC Oral Health. 2025 May 23;25(1):777. doi: 10.1186/s12903-025-06125-9.
PubMed 40410721
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Manuka Honey Oral Rinse in Treatment of Xerostomia in Elderly: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06240806
- Acronym / sponsor ID
- 23-061
- Conditions
- Dry Mouth, Salivary Gland Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 5 Feb 2024 (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.
Xerostomia causes many clinical problems, including oral infections, speech difficulties, and impaired chewing and swallowing of food thus may affect the individual's quality of life, therefore this study aimed to evaluate the clinical effectiveness of Manuka honey mouth rinse using the subjective dry mouth score, and patient satisfaction as primary objectives and to assess the effect of Manuka honey on the salivary flow rate, and objective dry mouth score as secondary objectives.
Detailed description
Xerostomia has a variety of possible etiological factors; it is generally classified as having primary and secondary causes. Primary causes comprise conditions that directly affect the salivary glands and induce xerostomia like, Sjogren's syndrome, diabetes mellitus type 1 and 2, thyroid disease, adrenal pathology, renal or hepatic diseases, hepatitis C virus infection, and HIV disease.
Secondary causes of xerostomia include the side-effects of radiation therapy or chemotherapy, rheumatoid arthritis, scleroderma, mixed connective tissues diseases, systemic lupus erythematous, graft versus host disease, anorexia, alcohol and smoking and commonly prescribed drugs (>500 medications reportedly cause dry mouth). The most common medications causing hyposalivation are those with anticholinergic activity, sympathomimetic, and benzodiazepines. The risk of xerostomia increases with the synergistic effects of xerogenic medications, multiple medications, higher doses of medication, and the duration of the medication.
Honey was found to have several benefits as an alternative medicine, it has been used as a natural medicine for more than 2000 years, mainly for wound healing. Though there are many varieties of honey, only some of them e.g. Manuka honey and Malaysian Tualang honey, have been studied in detail for their medicinal properties.
Manuka honey is a monofloral honey, produced from the nectar of flowers of Manuka tree. This variety is produced from the Apis mellifera honey bees, using New Zealand Manuka plants producing specific floral-variety named as Leptospermum scoparium. The composition of Manuka honey consists of carbohydrates, minerals, proteins, fatty acids, phenolic and flavonoid compounds. Although such compounds are found in other types of honey, other unique features also occur in Manuka honey, such as an unusually high level of methylglyoxal (MGO) formed from dihydroxyacetone (DHA) which correlates with antibacterial activity.Manuka honey shows antioxidant and anticancer properties, which are considered due to its constituents-phytochemicals working as active bio-compounds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The experimental group will use a 20ml of (Manuka honey) in 100 ml purified water as mouthwash three times a day (preferably after their meals), kept it for one minute, and then poured it out . the control arm followed the same protocol with normal saline rinses in the same opaque bottles 3 times per day.
| Arm | Type | Receives |
|---|---|---|
| Manuka honey interventional arm | Active comparator | Other: Manuka HoneyManuka honey used as mouth rinse in treatment of xerostomia |
| Saline mouthwash control group | Placebo comparator | Other: Saline mouthwashSaline used as mouth rinse for xerostomia |
Who may qualify
- Ages
- 66 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- - Both genders, aged above 65 years.
- All patients must have complaint of xerostomia.
- Patients must be able to make reliable decision or communications.
Key exclusion criteria (5 listed)
- - Smoking, Alcohol.
- Patient with history of any serious illness as malignancy.
- Patients with any autoimmune disease.
- Vulnerable groups such as pregnant females, prisoners, mentally and physically handicapped individuals.
- Known hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation.
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 |
|---|---|---|
| Manuka HoneyManuka honey will be topically applied to the oral mucosa as oral rinse based on the Biswal et al., 2003 administration protocol. | Other | Manuka honey interventional arm |
| Saline mouthwashSaline mouthwash will be used 3 times per day for one month | Other | Saline mouthwash control group |
Primary outcome
Changes in subjective dry mouth score
Time frame: one month
changes in subjective dry mouth score [Time frame: baseline, 2 weeks, and 4 weeks] after manuka honey mouth rinse use higher number scores mean worse diagnosis while lower values mean better prognosis
3 secondary outcomes
Changes in objective dry mouth score
Time frame: one month
Increase in Unstimulated Salivary flow rate (ml/min)
Time frame: one month
Changes in salivary potential of hydrogen ion (pH)
Time frame: one month
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 5 Feb 2024.
- Derived from this study: PubMed 40410721Ghalwash D, El-Gawish A, Abou-Bakr A. Efficacy of Manuka honey oral rinse in treatment of xerostomia among elderly patients: a randomized controlled trial. BMC Oral Health. 2025 May 23;25(1):777. doi: 10.1186/s12903-025-06125-9.
Related trials for Dry Mouth
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manuka Honey and Saline mouthwash in people with Dry Mouth and Salivary Gland Diseases, run by British University In Egypt at 1 site in Egypt.
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 5 Feb 2024. 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 Egypt. 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 subjective dry mouth score (time frame: one month). 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 NCT06240806, 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 5 Feb 2024.