Evaluation of the Antibacterial Effect of a Toothpaste Containing Zinc Lactate

Oral Bacterial Infection Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05628571
• Other study ID #: CRO-2022-05-MC-MD-BZ-BS
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: February 1, 2023
• Est. completion date: June 30, 2023

Study information

• Verified date: November 2022
• Source: Hospital Israelita Albert Einstein
• Contact: Leticia M Bezinelli, PhD
• Phone: 55 11 91589350
• Email: lebezinelli[@]einstein.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

C

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: June 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bacterial Infections
• Oral Bacterial Infection

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein	Associação Latinoamericana para Promoção de Saúde Bucal e Pesquisa Odontológica (LAOHA), Colgate Palmolive

References & Publications (7)

Aguirre A, Mendoza B, Levine MJ, Hatton MN, Douglas WH. In vitro characterization of human salivary lubrication. Arch Oral Biol. 1989;34(8):675-7. doi: 10.1016/0003-9969(89)90024-1. — View Citation

Ben Lagha A, Yang Y, Trivedi HM, Masters JG, Grenier D. A Dual Zinc plus Arginine formulation attenuates the pathogenic properties of Porphyromonas gingivalis and protects gingival keratinocyte barrier function in an in vitro model. J Oral Microbiol. 2020 Aug 4;12(1):1798044. doi: 10.1080/20002297.2020.1798044. Erratum In: J Oral Microbiol. 2020 Sep 2;12(1):1813916. — View Citation

Carda-Dieguez M, Moazzez R, Mira A. Functional changes in the oral microbiome after use of fluoride and arginine containing dentifrices: a metagenomic and metatranscriptomic study. Microbiome. 2022 Sep 28;10(1):159. doi: 10.1186/s40168-022-01338-4. — View Citation

Creeth JE, Karwal R, Hara AT, Zero DT. A Randomized in situ Clinical Study of Fluoride Dentifrices on Enamel Remineralization and Resistance to Demineralization: Effects of Zinc. Caries Res. 2018;52(1-2):129-138. doi: 10.1159/000479823. Epub 2018 Jan 5. — View Citation

Delgado E, Garcia-Godoy F, Montero-Aguilar M, Mateo LR, Ryan M. A Clinical Investigation of a Dual Zinc plus Arginine Dentifrice in Reducing Established Dental Plaque and Gingivitis Over a Six-Month Period of Product Use. J Clin Dent. 2018 Sep;29(Spec No A):A33-40. — View Citation

Kindblom C, Davies JR, Herzberg MC, Svensater G, Wickstrom C. Salivary proteins promote proteolytic activity in Streptococcus mitis biovar 2 and Streptococcus mutans. Mol Oral Microbiol. 2012 Oct;27(5):362-72. doi: 10.1111/j.2041-1014.2012.00650.x. Epub 2012 May 25. — View Citation

Manus LM, Daep CA, Begum-Gafur R, Makwana E, Won B, Yang Y, Huang XY, Maloney V, Trivedi HM, Wu D, Masters JG. Enhanced In Vitro Zinc Bioavailability through Rational Design of a Dual Zinc plus Arginine Dentifrice. J Clin Dent. 2018 Sep;29(Spec No A):A10-19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of oral bacteria load	analysis of oral bacterial load (log10 colony-forming unit/mL) in saliva and oral mucosa biofilm samples, performed by microbial culture	Baseline (previously of the interventions) and after 4 weeks of the interventions
Secondary	Change of mucin expression in oral mucosa samples	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.	Baseline (previously of the interventions) and after 1, 2, 3 and 4 weeks of the interventions