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Completed

NCT Number: NCT06048627

Anti-gingivitis Mouthrinse

The purpose of this study is to prove whether a fluoride/zinc lactate containing mouthrinse is able to reduce dental plaque and gingival inflammation in patients who have gingivitis when applied twice daily during brushing at home over a period of 12 weeks.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Technische Universität Dresden

Dresden, 01307, Germany

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 20 uncrowned permanent natural teeth (excluding third molars).
  • Initial gingivitis index of at least 1.5 as determined by the use of the Gingival Index (Löe 1967).
  • Initial plaque index of at least 1.5 as determined by the use of the Plaque Index (Turesky et al. 1970).
  • Signed Informed Consent Form.

Exclusion criteria

  • Presence of orthodontic bands.
  • Malign tumor(s) of the soft or hard tissues of the oral cavity.
  • 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.
  • Participants who have systemic diseases that require regular systemic medication intake that may affect the gingival condition (e.g. antibiotics, phenytoin, nifedipine, cyclosporine, steroids, antiphlogistics).
  • Participants who require antibiotic treatments for dental appointments.
  • Participants with current moderate or severe chronic or aggressive periodontitis (periodontitis screening index [PSI] >2 in more than 2 sextants or PSI >3).
  • Subjects with caries requiring treatment (e.g., caries with cavity) or other oral diseases (including gingival hyperplasia, diseases of the oral mucosa);
  • Smokers or/and users of tobacco products.
  • Persons, who are unable to give their consent (e.g., persons who have limited legal capacity)

Treatment and study plan

Amine/zinc lactate/fluoride system

Drug

Amine/zinc lactate/fluoride system (250 ppm F), meridol®, Colgate-Palmolive

Negative Control

Drug

Sodium fluoride mouthwash 250 ppm

Primary outcomes

  1. Whole-mouth Mean Modified Gingival Index (MGI)

    Time frame: Baseline, 3 weeks, 12 weeks, 24 weeks

    Gingivitis, gingival severity and gingival, interproximal scores as measured by the Gingival Index as difference from baseline to 24 weeks between the study groups.

Secondary outcomes

  1. Turesky Modification of the Quigley Hein Plaque Index (PI)

    Time frame: Baseline, 3 weeks, 12 weeks, 24 weeks

    Plaque, plaque severity and plaque interproximal scores as measured by the Plaque Index as difference from baseline to 24 weeks between the study groups and at each time-point.

  2. Intraoral scans

    Time frame: Baseline, 3 weeks, 12 weeks, 24 weeks

    Quantitative changes & before/after imagery from intraoral scans

  3. Patient-reported experiences

    Time frame: Baseline, 3 weeks, 12 weeks, 24 weeks

    Changes in participant-reported experience as determined through participant-questionnaire

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Official study title

Clinical Investigation to Assess the Efficacy of an Antimicrobial Mouthrinse in the Reduction of Established Plaque and Gingivitis: a 6-month Clinical Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 21, 2023
Registry last updated
May 21, 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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