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

Sponsor

Colgate Palmolive (Industry)

Overall Status

Completed

CT.gov ID

NCT05821712

Collaborator

(none)

Enrollment

Location

Arms

6.6

Actual Duration (Months)

12.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Plaque Gum Disease	Drug: 0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride Mouthwash Drug: 0.057% sodium fluoride Mouthwash	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Mar 8, 2021

Actual Primary Completion Date :

Sep 24, 2021

Actual Study Completion Date :

Sep 24, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride Mouthwash mouthwash	Drug: 0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride Mouthwash mouthwash
Active Comparator: 0.057% sodium fluoride Mouthwash mouthwash	Drug: 0.057% sodium fluoride Mouthwash mouthwash

Arm

Intervention/Treatment

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

mouthwash

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

mouthwash

Active Comparator: 0.057% sodium fluoride Mouthwash

mouthwash

Drug: 0.057% sodium fluoride Mouthwash

mouthwash

Outcome Measures

Primary Outcome Measures

Gingival inflammation [baseline]
Loe-Silness Gingival Index
Gingival inflammation [3 months]
Loe-Silness Gingival Index
Gingival inflammation [6 months]
Loe-Silness Gingival Index

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinica Odontoiatrica Montesani	Roma	Rome	Italy	00187

Sponsors and Collaborators

Colgate Palmolive

Investigators

Principal Investigator: Luigi Montesani, MD, DDS, Clinica Odontoiatrica Montesani

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Colgate Palmolive

ClinicalTrials.gov Identifier:

NCT05821712

Other Study ID Numbers:

CRO-2020-12-PGN-MMW-ITA-YPZ

First Posted:

Apr 20, 2023

Last Update Posted:

Apr 20, 2023

Last Verified:

Apr 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 20, 2023