Clinical trial NCT06366568: Efficacy of a Eugenol-based Product to Improve the Quality of Toothbrushing and Relieving Gum Discomfort Areas
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plaque, Dental
Keywords: plaque gingivitis
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2024-04-16
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Turesky Modification of the Quigley & Hein Plaque Index
timeFrame: baseline and six months
Secondary outcomes:
measure: questionnaire
timeFrame: six months
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus Technische Universität Dresden Department of Periodontology Fetscherstras
Study officials:
References: