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

Primary Purpose

Blood Pressure, Periodontal Diseases

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Propolis
Sponsored by
University of Plymouth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Blood Pressure

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Plymouth

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Chlorhexidine

Propolis

Arm Description

Chlorhexidine mouthwash will be provided to participants for a week to rinse the mouth twice a day.

Propolis mouthwash will be provided to participants for a week to rinse the mouth twice a day.

Outcomes

Primary Outcome Measures

Enhanced activity of oral bacteria
The nitrate-reducing nitrate activity of oral bacterial will be measured before and after each treatment
Enhanced cardiovascular function
Blood pressure and microvascular response to a hyperaemia reactive test will be measured before and after each treatment

Secondary Outcome Measures

Full Information

First Posted
October 3, 2019
Last Updated
May 17, 2022
Sponsor
University of Plymouth
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1. Study Identification

Unique Protocol Identification Number
NCT04117451
Brief Title
The Effect of Propolis Mouthwash Compared to Chlorhexidine Mouthwash on Oral and Cardiovascular Health
Official Title
The Effect of Propolis Mouthwash Compared to Chlorhexidine Mouthwash on Oral and Cardiovascular Health
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 5, 2019 (Actual)
Primary Completion Date
March 30, 2022 (Actual)
Study Completion Date
May 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Plymouth

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Pressure, Periodontal Diseases

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chlorhexidine
Arm Type
Sham Comparator
Arm Description
Chlorhexidine mouthwash will be provided to participants for a week to rinse the mouth twice a day.
Arm Title
Propolis
Arm Type
Experimental
Arm Description
Propolis mouthwash will be provided to participants for a week to rinse the mouth twice a day.
Intervention Type
Other
Intervention Name(s)
Propolis
Intervention Description
Investigating the impact of propolis mouthwash on oral and cardiovascular health
Primary Outcome Measure Information:
Title
Enhanced activity of oral bacteria
Description
The nitrate-reducing nitrate activity of oral bacterial will be measured before and after each treatment
Time Frame
1 week
Title
Enhanced cardiovascular function
Description
Blood pressure and microvascular response to a hyperaemia reactive test will be measured before and after each treatment
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of Plymouth
City
Plymouth
State/Province
Devon
ZIP/Postal Code
PL4 8AA
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data will be shared for collaborative research.

Learn more about this trial

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

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