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OpenTrials
Completed

NCT Number: NCT04117451

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Plymouth

Plymouth, Devon, PL4 8AA, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy individuals between 18 and 50 years old

Exclusion criteria

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

Treatment and study plan

Propolis

Other

Investigating the impact of propolis mouthwash on oral and cardiovascular health

Primary outcomes

  1. Enhanced activity of oral bacteria

    Time frame: 1 week

    The nitrate-reducing nitrate activity of oral bacterial will be measured before and after each treatment

  2. Enhanced cardiovascular function

    Time frame: 1 week

    Blood pressure and microvascular response to a hyperaemia reactive test will be measured before and after each treatment

Sponsors and collaborators

Lead sponsor

University of Plymouth

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 7, 2019
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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