PlaquePhase 3NCT05821712

A New Mouthwash on Reducing Dental Plaque and Helping Prevent Gum Problems

A Phase 3 study testing 0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride Mouthwash and 0.057% sodium fluoride Mouthwash in people with Plaque and Gum Disease, run by Colgate Palmolive at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This 6-month clinical study was designed to investigate clinical efficacy on plaque and gingivitis for the Meridol Base Mouthwash containing 0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride as compared to a Negative Control Mouthwash containing 0.057% sodium fluoride after 3 and 6 months of product… Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Plaque, Gum Disease
What is being tested?: 0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride Mouthwash and 0.057% sodium fluoride Mouthwash
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteItaly
Study dates: 8 Mar 2021to 24 Sep 2021
Phase: Phase 3
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 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subjects, ages 18-70, inclusive.
Availability for the six-month duration of the clinical research study.
Good general health.
Initial gingivitis index of at least 1.0 as determined by the use of the Loe-Silness Gingival Index.
Initial plaque index of at least 1.5 as determined by the use of the Quigley-Hein Plaque Index.
Signed Informed Consent Form

Who cannot join

Presence of orthodontic bands.
Tumor(s) of the soft or hard tissues of the oral cavity.
Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
Five or more carious lesions requiring immediate restorative treatment.
Antibiotic use any time during the one-month period prior to entry into the study.
Participation in any other clinical study or test panel within the one month prior to entry into the study.

Show all 12Show fewer

Dental prophylaxis during the past two weeks prior to baseline examinations.
History of allergies to oral care/personal care consumer products or their ingredients.
On any prescription medicines that might interfere with the study outcome.
An existing medical condition that prohibits eating or drinking for periods up to 4 hours.
History of alcohol or drug abuse.
Self-reported pregnant or lactating subjects

Trial locations and contacts

1 site in 1 country.

Italy1 site

Clinica Odontoiatrica Montesani
Roma, Rome, 00187

Other trials in Italy

About this study

Official title: Investigation of Clinical Efficacy of a New Mouthwash on Reducing Dental Plaque and Helping Prevent Gum Problems as Compared to a Control Mouthwash - a Six-month Study in Italy

Conditions: Plaque, Gum Disease
Being tested: 0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride Mouthwash, 0.057% sodium fluoride Mouthwash
Medical subject headings: Plaque, Amyloid, Gingival Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride MouthwashDrug
mouthwash
0.057% sodium fluoride MouthwashDrug
mouthwash

Study groups in NCT05821712
Study group	Role	What they receive
0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride Mouthwash	Experimental	mouthwash Receives: Drug: 0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride Mouthwash
0.057% sodium fluoride Mouthwash	Active comparator	mouthwash Receives: Drug: 0.057% sodium fluoride Mouthwash

What is being measured

The primary outcome is the main question the study is designed to answer.

Gingival inflammation
Loe-Silness Gingival Index
Measured: baseline
Gingival inflammation
Loe-Silness Gingival Index
Measured: 3 months
Gingival inflammation
Loe-Silness Gingival Index
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Mar 202124 Sep 2021

First posted20 Apr 2023
Study start8 Mar 2021
Primary completion24 Sep 2021
Study completion24 Sep 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PlaqueStudies of the same condition, open and under way.
More trials run by Colgate PalmoliveThe 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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05821712
Sponsor's protocol ID: CRO-2020-12-PGN-MMW-ITA-YPZ
Status last verified: Apr 2023
First submitted: 27 Mar 2023
Last updated: 20 Apr 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Montesani L, Montesani L, Mateo L, Daep C, Huber N, Isapour G, Zhang YP. Antibacterial and clinical effectiveness of a mouthwash with a novel active system of amine + zinc lactate + fluoride: a randomized controlled trial. Clin Oral Investig. 2024 Jan 13;28(1):90. doi: 10.1007/s00784-023-05487-0.
PubMed 38217757

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
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A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
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Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
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All Plaque trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigation of Clinical Efficacy of a New Mouthwash on Reducing Dental Plaque and Helping Prevent Gum Problems as Compared to a Control Mouthwash - a Six-month Study in Italy
ClinicalTrials.gov ID: NCT05821712
Acronym / sponsor ID: CRO-2020-12-PGN-MMW-ITA-YPZ
Conditions: Plaque, Gum Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Colgate PalmoliveIndustry (pharma, biotech, devices)
Study start: 8 Mar 2021 (actual)
Primary completion: 24 Sep 2021 (actual)
Study completion: 24 Sep 2021 (actual)
First posted: 20 Apr 2023 (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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride Mouthwash	Experimental	Drug: 0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride Mouthwashmouthwash
0.057% sodium fluoride Mouthwash	Active comparator	Drug: 0.057% sodium fluoride Mouthwashmouthwash

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Subjects, ages 18-70, inclusive.
Availability for the six-month duration of the clinical research study.
Good general health.
Initial gingivitis index of at least 1.0 as determined by the use of the Loe-Silness Gingival Index.
Initial plaque index of at least 1.5 as determined by the use of the Quigley-Hein Plaque Index.

Key exclusion criteria (12 listed)

Presence of orthodontic bands.
Tumor(s) of the soft or hard tissues of the oral cavity.
Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
Five or more carious lesions requiring immediate restorative treatment.
Antibiotic use any time during the one-month period prior to entry into the study.

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
0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride Mouthwashmouthwash	Drug	0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride Mouthwash
0.057% sodium fluoride Mouthwashmouthwash	Drug	0.057% sodium fluoride Mouthwash

Primary outcome

Gingival inflammation
Time frame: baseline
Loe-Silness Gingival Index
Gingival inflammation
Time frame: 3 months
Loe-Silness Gingival Index
Gingival inflammation
Time frame: 6 months
Loe-Silness Gingival Index

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 20 Apr 2023.
Derived from this study: PubMed 38217757Montesani L, Montesani L, Mateo L, Daep C, Huber N, Isapour G, Zhang YP. Antibacterial and clinical effectiveness of a mouthwash with a novel active system of amine + zinc lactate + fluoride: a randomized controlled trial. Clin Oral Investig. 2024 Jan 13;28(1):90. doi: 10.1007/s00784-023-05487-0.

Related trials for Plaque

Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Master Protocol Studying Multiple Amyloid-Targeting Therapies in Healthy Participants and Participants With Alzheimer's Disease
Alzheimer Disease, Amyloid
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 2
A Phase 2b Clinical Trial of YN001 in Adults With Coronary Atherosclerosis
Atherosclerosis, Coronary Artery Disease
Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Microbiome, Cytokines

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.

Luigi Montesani, MD, DDS principal investigator

Clinica Odontoiatrica Montesani

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 12 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 20 Apr 2023. 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 Italy. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Gingival inflammation (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05821712, which also lists 1 linked publication.

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 20 Apr 2023.