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Completed

NCT Number: NCT06770114

Clinical Study to Investigate a New Mouthwash in Reducing Plaque and Helping Prevent Gum Problems on Dental Implants Over a 6-month Period of Product Use

The objective of this six-month clinical research study is to evaluate the clinical efficacy of a new mouthwash on helping prevent gum problems (gingival index scores ) in adults as compared to a control mouthwash.

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Key information

Conditions

Gingivitis Gingival Diseases Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases

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

  • Availability for the six-month duration of the clinical research study.
  • Good general health.
  • Minimum of two dental implants (2 different quadrants ), each implant must have a restoration.
  • Initial mucositis index of at least 1 .0 as determined by the use of the Mombelli Modified Gingival Index.
  • Initial plaque index of at least 1 .5 as determined by the use of the Mombelli Modified 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 ) or peri-implantitis.
  • 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

Cetylpyridinium Chloride, Zinc Lactate and Hyaluronic Acid Mouthwash

Drug

0 .075 % cetylpyridinium chloride and 0 .28 % zinc lactate

PhosFlur Mouthwash

Drug

0 .044 % sodium fluoride

Primary outcomes

  1. Mombelli Modified Gingival Index

    Time frame: baseline

    Initial mucositis index of at least 1.0 as determined by the use of the Mombelli Modified Gingival

  2. Mombelli Modified Gingival Index

    Time frame: three month

    Initial mucositis index of at least 1.0 as determined by the use of the Mombelli Modified Gingival

  3. Mombelli Modified Gingival Index

    Time frame: six month

    Initial mucositis index of at least 1.0 as determined by the use of the Mombelli Modified Gingival

  4. Mombelli Modified Plaque Index

    Time frame: baseline

    Initial plaque index of at least 1 .5 as determined by the use of the Mombelli Modified Plaque

  5. Mombelli Modified Plaque Index

    Time frame: three month

    Initial plaque index of at least 1 .5 as determined by the use of the Mombelli Modified Plaque

  6. Mombelli Modified Plaque Index

    Time frame: six month

    Initial plaque index of at least 1 .5 as determined by the use of the Mombelli Modified Plaque

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Official study title

A Clinical Study to Investigate a New Mouthwash Containing 0.075% CPC, and 0.1% Hyaluronic Acid and 0.28% Zinc Lactate as Compared to a Fluoride Mouthwash Containing 0.044% NaF in Reducing Plaque and Helping Prevent Gum Problems on Dental Implants Over a 6-month Period of Product Use

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 13, 2025
Registry last updated
Dec 1, 2025

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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