Efficacy of a Eugenol-based Product to Improve the Quality of Toothbrushing and Relieving Gum Discomfort Areas
- Conditions
- Plaque, Dental
- Interventions
- Drug: fluoride toothpaste containing 1450 ppm of MFP in a PCC base and eugenol gum productDrug: fluoride toothpaste containing 1450 ppm of MFP in a PCC base
- Registration Number
- NCT06366568
- Lead Sponsor
- Colgate Palmolive
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 fluoride toothpaste containing 1450 ppm of MFP in a PCC base and eugenol gum product toothpaste and gum product, brushing 2x a day for 2 minutes followed by gum product application Group 2 fluoride toothpaste containing 1450 ppm of MFP in a PCC base toothpaste , brushing 2x a day for 2 minutes
- Primary Outcome Measures
Name Time Method Turesky Modification of the Quigley & Hein Plaque Index 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 Outcome Measures
Name Time Method questionnaire six months self-reported questionnaires are served as secondary efficacy variable.
Trial Locations
- Locations (1)
Universitätsklinikum Carl Gustav Carus Technische Universität Dresden Department of Periodontology Fetscherstras
🇩🇪Dresden, Germany