Wound HealNCT05270382
Effect of Mouthwashes on Oral Wound Healing and Microbiome
A study testing cetylpyridinium chloride in people with Wound Heal and Oral Microbiome, run by University of Illinois Chicago at 1 site in United States.
Trial summary
The purpose of this clinical research study is to investigate if mouthwashes to be tested can affect oral mucosal wound healing and change the oral microbiome (bacteria colonization) or expression of selected biomarkers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Wound Heal, Oral Microbiome
- What is being tested?
- cetylpyridinium chloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female volunteers 18-45 years of age.
- Good general health.
- Must sign informed consent form.
- Minimum of 17 natural uncrowned teeth (excluding third molars) must be present.
Who cannot join
- Oral pathology, chronic disease, or history of allergy to testing product.
- Medical condition which requires pre-medication prior to dental visits/procedures
- Moderate or advanced periodontal disease (gum disease) or periodontal probing depths greater than 4 mm.
- Five (5) or more decayed untreated dental sites at screening (cavities).
- Impaired salivary function.
- Use of medications that can currently affect salivary flow.
Show all 18Show fewer
- Use of anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, antibiotics, antimicrobial, anti-inflammatory medication or daily analgesics within 30 days prior to the start of the study or scheduled to start such intake during the course of the study.
- Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine)
- Pregnant or nursing women.
- Participation in any other clinical study within 1 week prior to enrollment into this study.
- Use of any tobacco products.
- Subjects who must receive dental treatment during the study dates.
- Presence of an orthodontic appliance that interferes with required clinical assessments.
- History of allergy to common dentifrice ingredients.
- Subjects who wear night guard, denture retainers
- Not willing to abstain from eating crunchy (eg. Granola bars, popcorns, nuts etc) or spicy and hot foods/liquids during the study period;
- Not willing to abstain from drinking citrus fluids, alcohol, and tea during the study period
- Non English-speaking subjects
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Research Center, College of Dentistry, University of Illinois Chicago
Chicago, Illinois, 60612
About this study
Official title: Clinical Research Study to Evaluate the Effect of Colgate Mouthwashes on Oral Microbiome in Oral Tissue Samples
The purpose of this clinical research study is to investigate if mouthwashes to be tested can affect oral mucosal wound healing and change the oral microbiome (bacteria colonization) or expression of selected biomarkers.
- Conditions
- Wound Heal, Oral Microbiome
- Being tested
- cetylpyridinium chloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cetylpyridinium chlorideOther
The mouthwash is used to see the effects on wound healing and the oral microbiome.
| Study group | Role | What they receive |
|---|---|---|
| Cetylpyridinium chloride/pH adjuster 1 | Active comparator | A mouthwash contains cetylpyridinium chloride and pH adjuster 1. Receives: Other: cetylpyridinium chloride |
| Placebo 1 | Placebo comparator | A mouthwash without cetylpyridinium chloride and pH adjuster 1 Receives: Other: cetylpyridinium chloride |
| Cetylpyridinium chloride/pH adjuster 2 | Active comparator | A mouthwash contains cetylpyridinium chloride and pH adjuster 2. Receives: Other: cetylpyridinium chloride |
| Placebo 2 | Placebo comparator | A mouthwash without cetylpyridinium chloride and pH adjuster 2 Receives: Other: cetylpyridinium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing
Images of the oral wounds will be taken before and after using the mouthwash treatment on days 1, 3, 5, and 7. The images will be taken on a digital camera. The wound sizes will be measured in mm2 using ImageJ software. The wound size will be measured at each time point and will be compared between a tested mouthwash and its placebo.
Measured: 7 Days
Microbiome
Swabs will be collected from the hard palate on both the wounded and unwounded sides before and after injury and the mouthwash treatment at days 1, 3, 5, and 7. 16S rRNA sequencing will be performed to determine the bacteria microbiome. Correlations and relative abundance of bacteria will be compared at phylum and genus levels using bioinformatics tools between a mouthwash treated group and its placebo at different time points.
Measured: 5 Days
Secondary outcomes (1)
Biomarker expression
Real time polymerase chain reaction will be used to assess the mRNA expression of biomarkers in wound biopsy samples collected at days 1 and 3 post wounding and mouthwash treatment. The biomarkers include collagen I, collagen III, metalloproteinase-2, metalloproteinase-9, Interleukin-1β, Interleukin-6, and vascular endothelial growth factor. The fold changes of biomarker mRNA expression at each time point over the expression in unwounded tissues will be compared between a tested mouthwash and its placebo.
Measured: 3 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start1 Feb 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Praveen Kumar Gajendrareddy, University of Illinois Chicago
- Investigators
- Praveen Gajendrareddy, BDS, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05270382
- Sponsor's protocol ID
- 2018-1417
- Other IDs
- CRO-2018-SAL-08-MW-DC
- Status last verified
- Feb 2024
- First submitted
- 7 Dec 2021
- Last updated
- 22 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research Study to Evaluate the Effect of Colgate Mouthwashes on Oral Microbiome in Oral Tissue Samples
- ClinicalTrials.gov ID
- NCT05270382
- Acronym / sponsor ID
- 2018-1417
- Conditions
- Wound Heal, Oral Microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 8 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical research study is to investigate if mouthwashes to be tested can affect oral mucosal wound healing and change the oral microbiome (bacteria colonization) or expression of selected biomarkers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cetylpyridinium chloride/pH adjuster 1 | Active comparator | Other: cetylpyridinium chlorideA mouthwash contains cetylpyridinium chloride and pH adjuster 1. |
| Placebo 1 | Placebo comparator | Other: cetylpyridinium chlorideA mouthwash without cetylpyridinium chloride and pH adjuster 1 |
| Cetylpyridinium chloride/pH adjuster 2 | Active comparator | Other: cetylpyridinium chlorideA mouthwash contains cetylpyridinium chloride and pH adjuster 2. |
| Placebo 2 | Placebo comparator | Other: cetylpyridinium chlorideA mouthwash without cetylpyridinium chloride and pH adjuster 2 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female volunteers 18-45 years of age.
- Good general health.
- Must sign informed consent form.
- Minimum of 17 natural uncrowned teeth (excluding third molars) must be present.
Key exclusion criteria (18 listed)
- Oral pathology, chronic disease, or history of allergy to testing product.
- Medical condition which requires pre-medication prior to dental visits/procedures
- Moderate or advanced periodontal disease (gum disease) or periodontal probing depths greater than 4 mm.
- Five (5) or more decayed untreated dental sites at screening (cavities).
- Impaired salivary function.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cetylpyridinium chlorideThe mouthwash is used to see the effects on wound healing and the oral microbiome. | Other | Cetylpyridinium chloride/pH adjuster 1, Cetylpyridinium chloride/pH adjuster 2, Placebo 1, Placebo 2 |
Primary outcome
Wound healing
Time frame: 7 Days
Images of the oral wounds will be taken before and after using the mouthwash treatment on days 1, 3, 5, and 7. The images will be taken on a digital camera. The wound sizes will be measured in mm2 using ImageJ software. The wound size will be measured at each time point and will be compared between a tested mouthwash and its placebo.
Microbiome
Time frame: 5 Days
Swabs will be collected from the hard palate on both the wounded and unwounded sides before and after injury and the mouthwash treatment at days 1, 3, 5, and 7. 16S rRNA sequencing will be performed to determine the bacteria microbiome. Correlations and relative abundance of bacteria will be compared at phylum and genus levels using bioinformatics tools between a mouthwash treated group and its placebo at different time points.
1 secondary outcome
Biomarker expression
Time frame: 3 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Wound Heal
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Feasibility of a Digital Self-help Program for Functional Hypothalamic Amenorrhea (HEAL-FHA Pilot)
Functional Hypothalamic Amenorrhea
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Active, not recruiting
Alveolar Ridge Reconstruction in Post-extraction Sites Using a Magnesium Resorbable Membrane. An Explorative Study
Bone Augmentation, Alveolar Ridge Augmentation
Recruiting
Effect Of Resistive Capactive Electrical Transfer Therapy In Difficult-to-heal Wounds
Difficult-to-heal Wounds
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Praveen Gajendrareddy, BDS, PhD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cetylpyridinium chloride in people with Wound Heal and Oral Microbiome, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing (time frame: 7 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.