Evaluation of the Antibacterial Effect of a Toothpaste Containing Zinc Lactate

Sponsor

Hospital Israelita Albert Einstein (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05628571

Collaborator

Colgate Palmolive (Industry), Associação Latinoamericana para Promoção de Saúde Bucal e Pesquisa Odontológica (LAOHA) (Other)

130

Enrollment

Arms

4.9

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The aim of this study is to evaluate the antibacterial effect 12 hours after 4-week use of a toothpaste containing amine base, zinc lactate, and fluoride. For this, healthy people will be invited to use two different toothpaste: control - containing only fluoride; test - containing fluoride plus a combination with zinc. The primary outcome is the efficacy of the test toothpaste in the oral bacterial load reduction in samples of saliva and oral mucosa (obtained through scraping); the second outcome is effect of the test toothpaste in the expression of mucin in the oral mucosa.

Condition or Disease	Intervention/Treatment	Phase
Oral Bacterial Infection	Combination Product: Zinc toothpaste Combination Product: Fluoride Toothpaste	Phase 3

Detailed Description

Study Design This is a phase III, randomized, single center, parallel-group, double-blind clinical study to evaluate the antibacterial effect of a toothpaste containing an amine, zinc lactate, and fluoride base.

Primary Objective The objective of this study is to evaluate the antibacterial effect 12 hours after using a toothpaste containing amine, zinc lactate and fluoride for 4 weeks.

Secondary Objectives The secondary objective will be to evaluate the impact of a toothpaste containing amine, zinc lactate and fluoride in the quantification of mucin on the surface of the oral mucosa.

Study Intervention Design: Parallel Product Assignment: Randomization Number of individuals:

130 Individuals by age group: 18 to 70 Number of test groups: 2 Treatment regimen: Brushing of the entire mouth with test toothpaste Blind Mode: Double-blind Number of exposures (uses): Twice a day, unattended Study duration: 6 weeks Washout period: Yes Duration of each exposure: 2 minutes of brushing

Study Groups:

Test Group: Toothpaste containing amine base, zinc lactate and fluorine (1400 ppm F).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

130 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Masking Description:

Randomization lists will be kept confidential by the Investigator, inside a locked cabinet. As patients are included by the Examiner at the first visit (T0), the Investigator will make the allocation. The Examiner and other team members, including the Laboratory Technician, will not know the group to which the patient belongs. Toothpastes will be covered with white paper to disguise the identity of the product. Participants will also not know which group they belong to and which investigational product they are using. To this end, the products will be distributed in a separate area of the exam room by the Assistant, without the other participants being present. The samples will also be labeled with the information of the participant's first and last name initials, the randomization code and the sample collection data (type, intraoral location and collection date). The Laboratory Technician will not know which group the sample belongs to.

Primary Purpose:

Prevention

Official Title:

Clinical Research Study to Evaluate the Antibacterial Effect 12 Hours After 4-week Use of a Toothpaste Containing Amine Base, Sodium Fluoride and Zinc Lactate

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Apr 30, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Fluoride toothpaste Participants will brush their teeth with a commercially available Fluoride toothpaste (1450 ppm F) and a commercially available adult soft bristle toothbrush	Combination Product: Fluoride Toothpaste Participants will brush their teeth with a commercially available, soft-bristle adult toothbrush and toothpaste containing fluoride (1450 ppm F).
Experimental: Zinc toothpaste Participants will brush their teeth with a toothpaste containing amine base, zinc lactate and fluoride (1400 ppm F) and a commercially available adult soft bristle toothbrush	Combination Product: Zinc toothpaste Participants will brush their teeth with a commercially available, soft-bristle adult toothbrush and toothpaste containing amine-based zinc lactate (0.1%) and fluoride (1400 ppm F).

Arm

Intervention/Treatment

Placebo Comparator: Fluoride toothpaste

Participants will brush their teeth with a commercially available Fluoride toothpaste (1450 ppm F) and a commercially available adult soft bristle toothbrush

Combination Product: Fluoride Toothpaste

Participants will brush their teeth with a commercially available, soft-bristle adult toothbrush and toothpaste containing fluoride (1450 ppm F).

Experimental: Zinc toothpaste

Participants will brush their teeth with a toothpaste containing amine base, zinc lactate and fluoride (1400 ppm F) and a commercially available adult soft bristle toothbrush

Combination Product: Zinc toothpaste

Participants will brush their teeth with a commercially available, soft-bristle adult toothbrush and toothpaste containing amine-based zinc lactate (0.1%) and fluoride (1400 ppm F).

Outcome Measures

Primary Outcome Measures

Change of oral bacteria load [Baseline (previously of the interventions) and after 4 weeks of the interventions]
analysis of oral bacterial load (log10 colony-forming unit/mL) in saliva and oral mucosa biofilm samples, performed by microbial culture

Secondary Outcome Measures

Change of mucin expression in oral mucosa samples [Baseline (previously of the interventions) and after 1, 2, 3 and 4 weeks of the interventions]
quantification of mucin expression produced by the mucin gene (pg/mL) present in samples of the jugal mucosa, performed by means of an ELISA immunoenzymatic test.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Male and female subjects, ages 18-70, inclusive;
Subjects are available during study duration;
Subject is in good general health;
A minimum of 15 natural teeth with facial and lingual scorable surfaces, excluding third molars.
A willingness to read, understand, and sign the Informed Consent Form after the nature of the study has been fully explained to them.
Subjects with baseline whole mouth scores of dental plaque of 1.5 or more and gingivitis index of 1.0 or more.

Exclusion Criteria:

Participation in any other clinical study or test panel including clinical studies with oral hygiene formulations within the one month prior to entry into the study.
History of dental prophylaxis or treatments in the past month or during study duration.
History of medical treatments (e.g: antibiotic, anti-inflammatory, anticoagulant, etc.) during the month preceding study enrollment.
Subjects scheduled for any medical procedure during the course of the study.
Difficulty complying with study procedures and examinations such as excessive gagging during oral assessment etc.
History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses. Allergies to personal care/consumer products or their ingredients.
History of diabetes, hepatic, renal disease, inflammatory conditions or transmittable diseases, e.g. heart disease or AIDS.
History of rheumatic fever or medical conditions that require prophylactic antibiotics coverage prior to dental procedures.
Presence of oral lesions.
History of active or severe periodontal disease (PD > 4) and loose teeth.
Gross dental caries, severe generalized cervical abrasion and/or enamel abrasion, large fractured or temporary restorations (based on visual examinations).
Fixed or removable orthodontic appliances or removable partial dentures.
Current smokers and subjects with a history of alcohol or drug abuse.
Use of phenolic flavored products, such as mint flavored candies and chewing gum, during the study period.
Unable to refrain from oral hygiene for twelve (12) hours prior to scheduled visits.
Positive Coronavirus Disease 2019 test 48 hours prior to the screening visit.