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

NCT06366568 | Completed Phase 3

• 1 other identifier: CRO-2022-10-PG-MER-MW-JG
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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

Keywords

plaque gingivitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• questionnaire

  six months

Study Arms (2)

Group 1

EXPERIMENTAL

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

Group 2

PLACEBO COMPARATOR

toothpaste , brushing 2x a day for 2 minutes

Drug: fluoride toothpaste containing 1450 ppm of MFP in a PCC base

Interventions

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

Group 1

fluoride toothpaste containing 1450 ppm of MFP in a PCC base DRUG

toothbrushing 2x a day for 2 minutes each time

Group 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

Universitätsklinikum Carl Gustav Carus Technische Universität Dresden Department of Periodontology Fetscherstras

Dresden, 01307, Germany

Location

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 16, 2024
• Study Start: February 19, 2024
• Primary Completion: March 6, 2024
• Study Completion: March 6, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)