Skip to content

The Effect of Propolis Mouthwash Compared to Chlorhexidine Mouthwash on Oral and Cardiovascular Health

The Effect of Propolis Mouthwash Compared to Chlorhexidine Mouthwash on Oral and Cardiovascular Health

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04117451
Enrollment
45
Registered
2019-10-07
Start date
2019-06-05
Completion date
2022-05-03
Last updated
2022-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure, Periodontal Diseases

Brief summary

The oral microbiome has recently emerged as a key contributor in nitric oxide (NO) homeostasis and vascular control by increasing nitrite bioavailability. Antibacterial mouthwash containing chlorhexidine has been shown to be effective in inhibiting the nitrate-reducing activity of oral bacteria, and increasing blood pressure in normotensive and hypertensive individuals. Recent research has also shown that chlorhexidine mouthwash lowered salivary pH and increased salivary lactate and glucose. This was also associated with changes on the activity and diversity of oral bacteria that are susceptible to increase the risk of periodontal disease. On the other hand, mouthwash containing propolis has similar antimicrobial effects than chlorhexidine, but adding some positive outcomes such as increased salivary antioxidant capacity. This may suggest that propolis mouthwash modulates the activity/diversity of oral bacteria. Thus, this study aims to investigate the effect of propolis mouthwash on the nitrate-reducing activity of oral bacteria and vascular function compared to chlorhexidine in healthy humans.

Detailed description

Methods: Participants: Adult healthy and non-smoker individuals will be recruited. The study will be approved by the Human Ethics Committee of the University of Plymouth. Main protocol: Participants will visit the laboratory on two different occasions. At the first visit, basic anthropometrical measurements will be taken before to collect a blood (6 mL) and saliva (3 mL) samples under fasting conditions. Then, the nitrate reducing capacity of oral bacteria will be measured using a 10 mL of a free-nitrite water solution containing sodium nitrate. Participants will rinse their mouth for 5 min. Then, the mouth rinse will be collected into a sterile tube to analyse the absolute concentration of nitrite. Following this, blood pressure will be taken in triplicate on the left arm using an electronic sphygmomanometer. Then, microvascular function will be measured on the left forearm (extensor digitorum) using a hyperaemia reactive test. At the end of this visit and following a double-blind and non-cross over design participants will be allocated in one group: 1) chlorhexidine mouthwash or 2) propolis mouthwash. Participants will be given 14 tubes of 10 mL of mouthwash to rinse their mouth twice a day for a week before to return to the laboratory a week later and to undertake the same measurements.

Interventions

OTHERPropolis

Investigating the impact of propolis mouthwash on oral and cardiovascular health

Sponsors

University of Plymouth
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

Healthy individuals between 18 and 50 years old

Exclusion criteria

1. Smoking 2. To have hypertension, dyslipidaemia, diabetes, cancer or other physiological and mental disorders 3. Existing interventions affecting the oral bacteria: mouthwash, tongue scrapes 4. To have taken antibiotics within the last month. 5. In females, to have irregular menstrual periods, less than or greater than 28 days over the last 3 months

Design outcomes

Primary

MeasureTime frameDescription
Enhanced activity of oral bacteria1 weekThe nitrate-reducing nitrate activity of oral bacterial will be measured before and after each treatment
Enhanced cardiovascular function1 weekBlood pressure and microvascular response to a hyperaemia reactive test will be measured before and after each treatment

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026