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Recruiting NCT07414173

6-month Clinical Investigation Assessing the Efficacy of an Antimicrobial Mouthrinse in Reducing Established Plaque and Improving Gum Health

Phase IV Interventional Gingivitis Dental Plaque Accumulation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Test Mouthrinse, Control Mouthrinse.
Who it may be relevant to
Registry conditions: Gingivitis, Dental Plaque Accumulation. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

The goal of this clinical trial is to evaluate the clinical efficacy of an antimicrobial mouthrinse, with a particular focus on its effect on established plaque and the improvement of gum health. Participants will: * Brush and rinse twice a day with the designated products for 6 months * Visit the clinic once every 3 months after baseline for reassessment.

Interventions

  • Other Test Mouthrinse
    Test Mouthrinse: 0.0553% NaF (250 ppm Fluoride), Amine and 0.2% Zinc Lactate dihydrate
  • Other Control Mouthrinse
    Control Mouthrinse: 0.0553% NaF(250 ppm Fluoride)

Primary outcome measures

  • Improvement of gum health as measured by the Gingival Index (Löe 1967) between the study groups. [Time frame: 6-month period]
Secondary outcome measures (1)
  • Plaque scores as measured by the Plaque Index (Turesky et al. 1970) between the study groups [Time frame: 6-month period]

Eligibility criteria

Inclusion criteria

  • Male and female subjects aged 18-70 years, inclusive.
  • Availability for the 6-month duration of the clinical research study.
  • Good general health based on the opinion of the study investigator.
  • Signed Informed Consent Form.
  • Minimum of 20 natural teeth (excluding third molars).
  • Initial gingivitis index of at least 1.5 as determined by the use of the Loe and Silness Gingival Index.
  • Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).

Exclusion criteria

  • Be under orthodontic treatment.
  • Presence of partial removable dentures.
  • Tumor(s) of the soft or hard tissues of the oral cavity.
  • Participants with current moderate or severe periodontitis (periodontitis screening index \[PSI\] >2 in more than 2 sextants or PSI >3), and/or 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 based on the examiner/PI opinion.
  • An existing medical condition that prohibits eating and/or drinking for periods up to 4 hours.
  • History of alcohol and/or drug abuse.
  • Self-reported pregnancy and/or lactating subjects.
  • Subjects with other oral diseases (including gingival hyperplasia, diseases of the oral mucosa), or any condition that the dental examiner considers exclusionary from the study.
  • Smokers or/and users of tobacco products.
  • Enrolled in an undergraduate, postgraduate, or academic dentistry program

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Germany · 1 center
  • SGS proderm GmbH — Schenefeld

Identifiers

NCT: NCT07414173 · CRO-2025-10-PG-MER-MW-ZM

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗