NCT05821712

Brief 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 use.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2021

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 8, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2021

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 20, 2023

Completed
Last Updated

April 20, 2023

Status Verified

April 1, 2023

Enrollment Period

7 months

First QC Date

March 27, 2023

Last Update Submit

April 7, 2023

Conditions

PlaqueGum Disease

Outcome Measures

Primary Outcomes (3)

  • Gingival inflammation

    Loe-Silness Gingival Index

    baseline

  • Gingival inflammation

    Loe-Silness Gingival Index

    3 months

  • Gingival inflammation

    Loe-Silness Gingival Index

    6 months

Study Arms (2)

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

EXPERIMENTAL

mouthwash

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

0.057% sodium fluoride Mouthwash

ACTIVE COMPARATOR

mouthwash

Drug: 0.057% sodium fluoride Mouthwash

Interventions

0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride MouthwashDRUG

mouthwash

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

mouthwash

0.057% sodium fluoride Mouthwash

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Odontoiatrica Montesani

Roma, Rome, 00187, Italy

Location

Related Publications (1)

  • 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.

    PMID: 38217757DERIVED

MeSH Terms

Conditions

Plaque, AmyloidGingival Diseases

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Luigi Montesani, MD, DDS

    Clinica Odontoiatrica Montesani

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2023

First Posted

April 20, 2023

Study Start

March 8, 2021

Primary Completion

September 24, 2021

Study Completion

September 24, 2021

Last Updated

April 20, 2023

Record last verified: 2023-04

Locations

IT(1)