Effect of Antibacterial Mouthwash on Muscle Function in Healthy Young Men and Women
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|ClinicalTrials.gov Identifier: NCT04095442|
Recruitment Status : Suspended (COVID-19 pandemic)
First Posted : September 19, 2019
Last Update Posted : April 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Quadriceps Muscle||Drug: Cepacol Drug: Tom's Natural Mouthwash||Early Phase 1|
Study Visit One:
During an initial visit, subjects will complete the informed consent process, be instructed on the requirements of the study, and practice the exercise protocol (see below).
Study Visit Two:
Subjects will be tested after they have avoided exercise, caffeine, alcohol, chewing gum, and foods high in nitrate (e.g., spinach, beets, collard greens) for at least 24 hours. They will also be asked to not use any mouthwash products during this period. They will then provide provide a saliva sample for subsequent measurement of nitrate and nitrite concentrations and have their breath nitric oxide levels measured using a portable analyzer. The maximal knee extensor speed and power of their knee extensor muscles will then be measured using an isokinetic dynamometer. This machine can control the speed of movement while measuring the maximal force (torque) that a subject can voluntarily produce.
Subjects will then be randomly assigned to receive either an antibacterial mouthwash (Cepacol©, Reckitt Benckiser, Parsippany, NJ) or, as a control solution, an alcohol-free "natural" mouthwash (Tom's of Maine©, Kennebunk, ME). Participants will be asked to rinse their mouth as directed on the product's packaging for 30 s twice per day for 7 (+/-2) days and to record the usage of the mouthwash on a provided form. Subjects will then return for Study Visit 3 (see below). This is considered a single-blind study, which means that the investigators will not know what type of mouthwash a subject is receives.
Study Visit Three:
At the end of the treatment period, subjects will be asked to return to undergo the same procedures as described for Study Visit Two.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||Effect of Antibacterial Mouthwash on Muscle Function in Healthy Young Men and Women|
|Actual Study Start Date :||November 1, 2019|
|Estimated Primary Completion Date :||October 2021|
|Estimated Study Completion Date :||October 2021|
|Active Comparator: Cepacol||
Twice-daily use of Cepacol per the manufacturer's guidelines
|Sham Comparator: Tom's Natural Mouthwash||
Drug: Tom's Natural Mouthwash
Twice-daily use of Tom's Natural Mouthwash per the manufacturer's guidelines
- Muscle function [ Time Frame: 1 day ]Maximal knee extensor speed and power determined using isokinetic dynamometry
- Muscle function [ Time Frame: 7 day ]Maximal knee extensor speed and power determined using isokinetic dynamometry
- Salivary nitrate/nitrite [ Time Frame: 1 day ]Salivary concentrations of nitrate and nitrite
- Salivary nitrate/nitrite [ Time Frame: 7 day ]Salivary concentrations of nitrate and nitrite
- Breath nitric oxide [ Time Frame: 1 day ]Breath nitric oxide level
- Breath nitric oxide [ Time Frame: 7 day ]Breath nitric oxide level
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04095442
|United States, Indiana|
|Indiana University School of Health and Human Sciences|
|Indianapolis, Indiana, United States, 46202|