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

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

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.

Study Overview

• Status: Completed
• Conditions: Plaque, Dental
• Intervention / Treatment: Drug: fluoride toothpaste containing 1450 ppm of MFP in a PCC base and eugenol gum product; Drug: fluoride toothpaste containing 1450 ppm of MFP in a PCC base

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Dresden, Germany, 01307
    • Universitätsklinikum Carl Gustav Carus Technische Universität Dresden Department of Periodontology Fetscherstras

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; toothpaste and gum product, brushing 2x a day for 2 minutes followed by gum product application	Drug: 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
Placebo Comparator: Group 2; toothpaste , brushing 2x a day for 2 minutes	Drug: fluoride toothpaste containing 1450 ppm of MFP in a PCC base; toothbrushing 2x a day for 2 minutes each time

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Turesky Modification of the Quigley & Hein Plaque Index	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.	baseline and six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
questionnaire	self-reported questionnaires are served as secondary efficacy variable.	six months

Collaborators and Investigators

• Sponsor: Colgate Palmolive

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2024
• Primary Completion (Actual): March 6, 2024
• Study Completion (Actual): March 6, 2024

Study Registration Dates

• First Submitted: April 3, 2024
• First Submitted That Met QC Criteria: April 15, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: plaque gingivitis
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Deposits; Dental Plaque; Physiological Effects of Drugs; Anti-Infective Agents; Protective Agents; Cariostatic Agents; Fluorides; Eugenol
• Other Study ID Numbers: CRO-2022-10-PG-MER-MW-JG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No