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

Plaque Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05821712
• Other study ID #: CRO-2020-12-PGN-MMW-ITA-YPZ
• Status: Completed
• Phase: Phase 3
• Start date: March 8, 2021
• Est. completion date: September 24, 2021

Study information

• Verified date: April 2023
• Source: Colgate Palmolive
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 use.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 24, 2021
• Est. primary completion date: September 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Plaque
• Gum Disease
• Plaque

Intervention

Drug:
• 0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride Mouthwash
mouthwash
• 0.057% sodium fluoride Mouthwash
mouthwash

Locations

Country	Name	City	State
Italy	Clinica Odontoiatrica Montesani	Roma	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Colgate Palmolive

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gingival inflammation	Loe-Silness Gingival Index	baseline
Primary	Gingival inflammation	Loe-Silness Gingival Index	3 months
Primary	Gingival inflammation	Loe-Silness Gingival Index	6 months