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Completed

NCT Number: NCT05821712

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinica Odontoiatrica Montesani

Roma, Rome, 00187, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

mouthwash

0.057% sodium fluoride Mouthwash

Drug

mouthwash

Primary outcomes

  1. Gingival inflammation

    Time frame: baseline

    Loe-Silness Gingival Index

  2. Gingival inflammation

    Time frame: 3 months

    Loe-Silness Gingival Index

  3. Gingival inflammation

    Time frame: 6 months

    Loe-Silness Gingival Index

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 20, 2023
Registry last updated
Apr 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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