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

Primary Purpose

Plaque, Gum Disease

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride Mouthwash
0.057% sodium fluoride Mouthwash
Sponsored by
Colgate Palmolive
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Plaque

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Clinica Odontoiatrica Montesani

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

0.057% sodium fluoride Mouthwash

Arm Description

mouthwash

mouthwash

Outcomes

Primary Outcome Measures

Gingival inflammation
Loe-Silness Gingival Index
Gingival inflammation
Loe-Silness Gingival Index
Gingival inflammation
Loe-Silness Gingival Index

Secondary Outcome Measures

Full Information

First Posted
March 27, 2023
Last Updated
April 7, 2023
Sponsor
Colgate Palmolive
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1. Study Identification

Unique Protocol Identification Number
NCT05821712
Brief Title
A New Mouthwash on Reducing Dental Plaque and Helping Prevent Gum Problems
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 8, 2021 (Actual)
Primary Completion Date
September 24, 2021 (Actual)
Study Completion Date
September 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Colgate Palmolive

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque, Gum Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride Mouthwash
Arm Type
Experimental
Arm Description
mouthwash
Arm Title
0.057% sodium fluoride Mouthwash
Arm Type
Active Comparator
Arm Description
mouthwash
Intervention Type
Drug
Intervention Name(s)
0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride Mouthwash
Intervention Description
mouthwash
Intervention Type
Drug
Intervention Name(s)
0.057% sodium fluoride Mouthwash
Intervention Description
mouthwash
Primary Outcome Measure Information:
Title
Gingival inflammation
Description
Loe-Silness Gingival Index
Time Frame
baseline
Title
Gingival inflammation
Description
Loe-Silness Gingival Index
Time Frame
3 months
Title
Gingival inflammation
Description
Loe-Silness Gingival Index
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luigi Montesani, MD, DDS
Organizational Affiliation
Clinica Odontoiatrica Montesani
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica Odontoiatrica Montesani
City
Roma
State/Province
Rome
ZIP/Postal Code
00187
Country
Italy

12. IPD Sharing Statement

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

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