Evaluation of the Antibacterial Effect of a Toothpaste Containing Zinc Lactate

Phase 3

Not yet recruiting

• Conditions: Oral Bacterial Infection
• Interventions: Combination Product: Fluoride Toothpaste; Combination Product: Zinc toothpaste

• Registration Number: NCT05628571
• Lead Sponsor: Hospital Israelita Albert Einstein

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.

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:

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

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Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-11-07
• Study First Submitted QC: 2022-11-24
• Study First Posted: 2022-11-28
• Last Update Submitted: 2023-01-11
• Last Update Posted: 2023-01-12
• Study Start: 2023-02-01
• Primary Completion: 2023-04-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

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

Exclusion Criteria

1. 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.
2. History of dental prophylaxis or treatments in the past month or during study duration.
3. History of medical treatments (e.g: antibiotic, anti-inflammatory, anticoagulant, etc.) during the month preceding study enrollment.
4. Subjects scheduled for any medical procedure during the course of the study.
5. Difficulty complying with study procedures and examinations such as excessive gagging during oral assessment etc.
6. 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.
7. History of diabetes, hepatic, renal disease, inflammatory conditions or transmittable diseases, e.g. heart disease or AIDS.
8. History of rheumatic fever or medical conditions that require prophylactic antibiotics coverage prior to dental procedures.
9. Presence of oral lesions.
10. History of active or severe periodontal disease (PD > 4) and loose teeth.
11. Gross dental caries, severe generalized cervical abrasion and/or enamel abrasion, large fractured or temporary restorations (based on visual examinations).
12. Fixed or removable orthodontic appliances or removable partial dentures.
13. Current smokers and subjects with a history of alcohol or drug abuse.
14. Use of phenolic flavored products, such as mint flavored candies and chewing gum, during the study period.
15. Unable to refrain from oral hygiene for twelve (12) hours prior to scheduled visits.
16. Positive Coronavirus Disease 2019 test 48 hours prior to the screening visit.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.