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

NCT04117451 | Completed

• 1 other identifier: UPlymouth
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure; Periodontal Diseases

Outcome Measures

Primary Outcomes (2)

• Enhanced activity of oral bacteria

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

  1 week

• Enhanced cardiovascular function

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

  1 week

Study Arms (2)

Chlorhexidine

SHAM COMPARATOR

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

Other: Propolis

Propolis

EXPERIMENTAL

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

Other: Propolis

Interventions

Propolis OTHER

Investigating the impact of propolis mouthwash on oral and cardiovascular health

Chlorhexidine; Propolis

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy individuals between 18 and 50 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Plymouth: lead

Study Sites (1)

University of Plymouth

Plymouth, Devon, PL4 8AA, United Kingdom

Location

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Propolis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Resins, Plant; Biopolymers; Polymers; Macromolecular Substances; Plant Exudates; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 7, 2019
• Study Start: June 5, 2019
• Primary Completion: March 30, 2022
• Study Completion: May 3, 2022
• Last Updated: May 18, 2022

Record last verified: 2022-05

Locations

GB (1)