An interventional study of Propolis in Blood Pressure and Periodontal Diseases, sponsored by University of Plymouth. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-18.
Sponsored by University of Plymouth · Not applicable, Interventional, and Supportive care
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.
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.
855 studies on the registry are indexed under Periodontal Diseases; 189 are open to participants now.
This study's enrollment of 45 is close to the median of 45 across 546 interventional studies indexed under Periodontal Diseases.
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Healthy individuals between 18 and 50 years old
Exclusion Criteria:
Chlorhexidine mouthwash will be provided to participants for a week to rinse the mouth twice a day.
Other: Propolis
Propolis mouthwash will be provided to participants for a week to rinse the mouth twice a day.
Other: Propolis
Investigating the impact of propolis mouthwash on oral and cardiovascular health
Enhanced activity of oral bacteria
The nitrate-reducing nitrate activity of oral bacterial will be measured before and after each treatment
Time frame: 1 week
Enhanced cardiovascular function
Blood pressure and microvascular response to a hyperaemia reactive test will be measured before and after each treatment
Time frame: 1 week
Plan to share: Undecided — Data will be shared for collaborative research.
No publications or documents are linked to this record.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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University of Plymouth