NCT04095442 is a NA clinical trial of Cepacol in Quadriceps Muscle, sponsored by Indiana University.

Who is sponsoring NCT04095442?

NCT04095442 is sponsored by Indiana University.

What drugs are being tested in NCT04095442?

Interventions in NCT04095442: Cepacol, Tom's Natural Mouthwash.

What condition does NCT04095442 study?

NCT04095442 studies Quadriceps Muscle.

Is NCT04095442 still recruiting?

NCT04095442 is currently completed. Last updated 18 March 2024.

Are results published for NCT04095442?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-03-18 · How we verify

NCT04095442

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Effect of Antibacterial Mouthwash on Muscle Function in Healthy Young Men and Women

Completed NA Results posted Last updated 18 March 2024

What this trial tests

NA trial testing Cepacol in Quadriceps Muscle in 32 participants. Completed in 20 March 2023.

Timeline

1 November 2019

Primary endpoint
20 March 2023

20 March 2023

Quick facts

Lead sponsor	Indiana University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	basic science
Enrollment	32
Start date	1 November 2019
Primary completion	20 March 2023
Estimated completion	20 March 2023
Sites	1 location across United States

Drugs / interventions tested

Cepacol — full drug profile →
Tom's Natural Mouthwash

Conditions studied

Quadriceps Muscle — all drugs for Quadriceps Muscle →

Sponsor

Indiana University

Who can join

Adults 18 to 30, any sex, with Quadriceps Muscle. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Muscle Function Primary · 1 day

Maximal knee extensor speed determined using isokinetic dynamometry

Group	Value	95% CI
Cepacol	11.0	± 2.2
Tom's Natural Mouthwash	13.1	± 2.5

Muscle Function Primary · 7 day

Maximal knee extensor speed determined using isokinetic dynamometry

Group	Value	95% CI
Cepacol	13.3	± 3.0
Tom's Natural Mouthwash	13.6	± 2.8

Salivary Nitrate Secondary · 1 day

Salivary concentration of nitrate

Group	Value	95% CI
Cepacol	407	± 229
Tom's Natural Mouthwash	595	± 359

Salivary Nitrite Secondary · 7 day

Salivary concentration of nitrite

Group	Value	95% CI
Cepacol	602	± 490
Tom's Natural Mouthwash	533	± 310

Breath Nitric Oxide Secondary · 1 day

Breath nitric oxide level

Group	Value	95% CI
Cepacol	17	± 10
Tom's Natural Mouthwash	20	± 9

Breath Nitric Oxide Secondary · 7 day

Breath nitric oxide level

Group	Value	95% CI
Cepacol	17	± 7
Tom's Natural Mouthwash	20	± 10

Sponsor's own description

The purpose of this study is to determine the effects of antibacterial mouthwash on muscle speed and power in healthy young men and women. We have previously demonstrated that drinking beetroot juice, a source of dietary nitrate and therefore nitric oxide, increases muscle function in this population. Antibacterial mouthwash has been shown to interfere with the conversion of dietary nitrate to nitric oxide. We therefore hypothesize that it will diminish nitric oxide bioavailability and inhibit muscle contractility.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Pilot randomized trial of the effect of antibacterial mouthwash on muscle contractile function in healthy young adults.
Gallardo EJ, Zoughaib WS, Singhal A, Hoffman RL, et al · · 2025 · PMID 39937800 · DOI 10.1371/journal.pone.0312961

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04095442 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Indiana University
Last refreshed: 18 March 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04095442.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing