Glucose Metabolism Disorders (Including Diabetes Mellitus)NCT07172009
The Effect of Chlorhexidine Mouthwash on Postprandial Glucose Response in Healthy Individuals
A study testing Chlorhexidine mouthwash in people with Glucose Metabolism Disorders (Including Diabetes Mellitus), run by University of Plymouth at 1 site in United Kingdom.
Trial summary
The digestion of carbohydrates begins in the mouth through the salivary enzyme amylase which breaks food starches into maltose and disaccharides. The mouth also has a large community of microorganisms which include bacteria, fungi, viruses and protozoa that can also assist in the digestion of carbohydrates. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glucose Metabolism Disorders (Including Diabetes Mellitus)
- What is being tested?
- Chlorhexidine mouthwash
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Jun 2022to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
None listed.
Who cannot join
- The main exclusion criteria is pregnancy, people following cancer treatment, taking immunosuppressant or antibiotics and using antibacterial mouthwash for less than 2 weeks before the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Plymouth
Plymouth, Devon, PL4 8AA
Raul Bescos, PhD, 07599034710, Raul.Bescos@plymouth.ac.uk
Patricia Casas, PhD, Patricia.Casas@plymouth.ac.uk
About this study
The digestion of carbohydrates begins in the mouth through the salivary enzyme amylase which breaks food starches into maltose and disaccharides. The mouth also has a large community of microorganisms which include bacteria, fungi, viruses and protozoa that can also assist in the digestion of carbohydrates. Mouthwashes containing antibacterial compounds such as chlorhexidine are used to kill oral bacteria, but current evidence indicates that a majority of these bacteria are essential for human health.
The aim of this study is to investigate whether chlorhexidine mouthwash can also affect the digestion of carbohydrates. At least 25 individuals will be recruited. Participants will visit the laboratory in two occasions. A saliva and blood sample (fingertip to measure blood glucose) will be taken at baseline. Then, using a randomized, cross-over and double-blind design, the participants will rinse their mouth for two minutes with a placebo or chlorhexidine mouthwash. Then, participants will eat 50 g of white bread and blood glucose will be measured (fingertips) every 30 min for the following 2 hours. Another saliva sample will be collected at the end of each test.
Read the detailed description
Blood glucose is measured at baseline and following food intake using a blood glucose meter (ACCU-CHEK Performa, Roche, USA). Participants are then provided with 10 mL of the assigned mouthwash according to randomisation. Mouthwashes are blinded for both researchers and participants, as they are prepared by an external individual, covered, and labelled with group numbers. This ensures that neither participants nor researchers can identify the treatment allocation.
Oral rinsing is performed for 2 minutes before participants spit out the mouthwash. The mouthwashes used include:
Chlorhexidine di-gluconate (0.2%) (Corsodyl, GlaxoSmithKline, England) Placebo (water with yellow food colouring)
Following the mouth rinse, participants consume a pre-weighed breakfast meal consisting of 40 g of Hubbard's Foodstore® strawberry jam (Sainsbury's Supermarkets Ltd., London, UK) spread over 50 g of soft white bread (Sainsbury's Supermarkets Ltd., Northern Ireland, UK).
Blood glucose measurements are taken at 15, 30, 45, 60, 90, and 120 minutes post-meal.Baseline blood glucose values are used as reference points. For analysis, only the differences between baseline and subsequent time-point measurements are considered. The mean iAUC is calculated for each mouthwash condition (chlorhexidine and placebo).
Each participant completes the protocol twice, once for each mouthwash condition, with a minimum washout period of 48 hours between sessions.
- Being tested
- Chlorhexidine mouthwash, Placebo mouthwash
- Medical subject headings
- Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine mouthwashOther
Rinsing the mouth with chlorhexidine mouthwash for 2 minutes before consuming 50 g of carbohydrates
Placebo mouthwashOther
Rinsing the mouth with placebo mouthwash for 2 minutes before consuming 50 g of carbohydrates
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine | Experimental | Not described Receives: Other: Chlorhexidine mouthwash |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start8 Jun 2022
- Primary completion10 Dec 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose Metabolism Disorders (Including Diabetes Mellitus)Studies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Plymouth
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raul Bescos, University of Plymouth
- Investigators
- Raul Bescos Garcia, Principal investigator, University of Plymouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172009
- Sponsor's protocol ID
- 3275
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chlorhexidine Mouthwash on Postprandial Glucose Response in Healthy Individuals
- ClinicalTrials.gov ID
- NCT07172009
- Acronym / sponsor ID
- 3275
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of PlymouthUniversity, hospital or other
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- 10 Dec 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 15 Sep 2025 (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 digestion of carbohydrates begins in the mouth through the salivary enzyme amylase which breaks food starches into maltose and disaccharides. The mouth also has a large community of microorganisms which include bacteria, fungi, viruses and protozoa that can also assist in the digestion of carbohydrates. Mouthwashes containing antibacterial compounds such as chlorhexidine are used to kill oral bacteria, but current evidence indicates that a majority of these bacteria are essential for human health.
The aim of this study is to investigate whether chlorhexidine mouthwash can also affect the digestion of carbohydrates. At least 25 individuals will be recruited. Participants will visit the laboratory in two occasions. A saliva and blood sample (fingertip to measure blood glucose) will be taken at baseline. Then, using a randomized, cross-over and double-blind design, the participants will rinse their mouth for two minutes with a placebo or chlorhexidine mouthwash. Then, participants will eat 50 g of white bread and blood glucose will be measured (fingertips) every 30 min for the following 2 hours. Another saliva sample will be collected at the end of each test.
Detailed description
Blood glucose is measured at baseline and following food intake using a blood glucose meter (ACCU-CHEK Performa, Roche, USA). Participants are then provided with 10 mL of the assigned mouthwash according to randomisation. Mouthwashes are blinded for both researchers and participants, as they are prepared by an external individual, covered, and labelled with group numbers. This ensures that neither participants nor researchers can identify the treatment allocation.
Oral rinsing is performed for 2 minutes before participants spit out the mouthwash. The mouthwashes used include:
Chlorhexidine di-gluconate (0.2%) (Corsodyl, GlaxoSmithKline, England) Placebo (water with yellow food colouring)
Following the mouth rinse, participants consume a pre-weighed breakfast meal consisting of 40 g of Hubbard's Foodstore® strawberry jam (Sainsbury's Supermarkets Ltd., London, UK) spread over 50 g of soft white bread (Sainsbury's Supermarkets Ltd., Northern Ireland, UK).
Blood glucose measurements are taken at 15, 30, 45, 60, 90, and 120 minutes post-meal.Baseline blood glucose values are used as reference points. For analysis, only the differences between baseline and subsequent time-point measurements are considered. The mean iAUC is calculated for each mouthwash condition (chlorhexidine and placebo).
Each participant completes the protocol twice, once for each mouthwash condition, with a minimum washout period of 48 hours between sessions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine | Experimental | Other: Chlorhexidine mouthwash |
| Placebo | Placebo comparator | Other: Placebo mouthwash |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- The main exclusion criteria is pregnancy, people following cancer treatment, taking immunosuppressant or antibiotics and using antibacterial mouthwash for less than 2 weeks before the study.
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 |
|---|---|---|
| Chlorhexidine mouthwashRinsing the mouth with chlorhexidine mouthwash for 2 minutes before consuming 50 g of carbohydrates | Other | Chlorhexidine |
| Placebo mouthwashRinsing the mouth with placebo mouthwash for 2 minutes before consuming 50 g of carbohydrates | Other | Placebo |
Primary outcome
Blood glucose
Time frame: 2 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
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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.
Raul Bescos Garcia principal investigator
University of Plymouth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chlorhexidine mouthwash in people with Glucose Metabolism Disorders (Including Diabetes Mellitus), run by University of Plymouth at 1 site in United Kingdom.
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 0 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 19 Sep 2025. 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raul Bescos Garcia (07599034710, Raul.Bescos@plymouth.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose (time frame: 2 hours). 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 19 Sep 2025.