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

NCT ID: NCT06366568

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-19
• Study Completion Date: 2024-03-06

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.

Conditions

Plaque, Dental

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group 1

toothpaste and gum product, brushing 2x a day for 2 minutes followed by gum product application

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

PARTICIPANTS WILL USE A EUGENOL BASED product PRIOR TO TOOTHBRUSHING

Group 2

toothpaste , brushing 2x a day for 2 minutes

Group Type: PLACEBO_COMPARATOR

fluoride toothpaste containing 1450 ppm of MFP in a PCC base

Intervention Type: DRUG

toothbrushing 2x a day for 2 minutes each time

Interventions

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

PARTICIPANTS WILL USE A EUGENOL BASED product PRIOR TO TOOTHBRUSHING

Intervention Type: DRUG

fluoride toothpaste containing 1450 ppm of MFP in a PCC base

toothbrushing 2x a day for 2 minutes each time

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Colgate Palmolive

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universitätsklinikum Carl Gustav Carus Technische Universität Dresden Department of Periodontology Fetscherstras

Dresden, , Germany

Countries

Germany

Other Identifiers

CRO-2022-10-PG-MER-MW-JG

Identifier Type: -

Identifier Source: org_study_id