Skip to main content
OpenTrials
Completed

NCT Number: NCT06366568

Efficacy of a Eugenol-based Product to Improve the Quality of Toothbrushing and Relieving Gum Discomfort Areas

The objective of this study is to evaluate the efficacy of a eugenol-based product in improving the quality of toothbrushing and relieving areas of gingival discomfort. This is a randomized, controlled, parallel, examiner-blind clinical trial.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Universitätsklinikum Carl Gustav Carus Technische Universität Dresden Department of Periodontology Fetscherstras

Dresden, 01307, Germany

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • You must provide consent to participate by signing this informed consent form.
  • Available for the two(2) week study duration.
  • You must be at least eighteen(18) years old and not older than seventy(70) years of age.
  • You must not smoke.
  • You must be in good general health for participation in the study, based on the opinion of the study investigator.
  • You must have at least 20 natural permanent teeth.
  • Your teeth must meet the scoring entry criteria for dental plaque and gingivitis(gum inflammation) at the discretion of the study examiner.
  • You must meet the scoring criteria for gum discomfort, determined using your responses to the survey questionnaire.
  • You must have no known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the study examiner.

Exclusion criteria

  • Medical condition which requires premedication prior to dental visits/procedures.
  • Presence of fix/ removable prosthodontics dentures that may interfere with this study clinical examinations.
  • Advanced periodontal disease (gum disease) and/or treatment for periodontal disease (including surgery) within the past twelve months.
  • Five (5) or more decayed, untreated dental sites (cavities) and/or any dental condition requiring urgent dental care.

Abnormalities/diseases of the soft or hard oral tissues.

  • Orthodontic appliances/bands/lingual bars that interfere with any clinical assessment (plaque scoring)
  • Current smokers and/or tobacco users and/or a history of alcohol or drug abuse.
  • Use of drugs that can affect salivary flow.
  • Use of antibiotics one (1) month prior to study entry and/or during participation in this study.
  • Use of any over the counter medications other than analgesics that could interfere with the study at PI discretion.
  • Self-reported pregnancy and/or breastfeeding.
  • Current Participation in another clinical study or during the month prior to this clinical study entry.
  • Known allergies and/or reactions to common dentifrice ingredients.
  • Medical condition which prohibits not eating/drinking or chewing gum for four (4) hours prior to your scheduled visits.
  • Immunocompromised conditions (AIDS, immunosuppressive drug therapy).
  • Infectious disease and/or other blood borne diseases (Hepatitis series, HIV, tuberculosis).

Treatment and study plan

fluoride toothpaste containing 1450 ppm of MFP in a PCC base and eugenol gum product

Drug

PARTICIPANTS WILL USE A EUGENOL BASED product PRIOR TO TOOTHBRUSHING

fluoride toothpaste containing 1450 ppm of MFP in a PCC base

Drug

toothbrushing 2x a day for 2 minutes each time

Primary outcomes

  1. Turesky Modification of the Quigley & Hein Plaque Index

    Time frame: baseline and six months

    Reduction in plaque measurement is served as primary efficacy variable are served. The scoring scheme for the Turesky Modification of the Quigley-Hein dental plaque index is as follows: 0 = no plaque. 1 = separate flecks of plaque at the cervical margin of the tooth. 2 = a thin continuous band of plaque (up to 1 mm) at the cervical margin of the tooth.

Secondary outcomes

  1. questionnaire

    Time frame: six months

    self-reported questionnaires are served as secondary efficacy variable.

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Official study title

Clinical Investigation to Assess the Efficacy of a Eugenol-based Product in Improving the Quality of Toothbrushing Measured by Plaque Assessment and Patient Perception Questionnaire and Relieving Gum Discomfort Areas

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 16, 2024
Registry last updated
Apr 16, 2024

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.

Published trials that share one or more normalized conditions with this study.