Efficacy of an Antibacterial Toothpaste and Patients' Satisfaction

NCT ID: NCT05569850

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2023-07-15

Brief Summary

The primary objective of this randomized controlled clinical trial (RCCT) will be to compare the efficacy in reducing the quantity of Streptococcus mutans (S. Mutans) in saliva of a recently introduced toothpaste compared to a commercially available toothpaste. The secondary outcomes will be to assess patients' impression of the toothpastes (in terms of taste, satisfaction etc.), and to investigate potential changes in dentin hypersensitivity, plaque formation and gingival inflammation.

Conditions

Caries; Gingivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Recently introduced toothpaste

Brushing twice a day with a recently introduced toothpaste.

Group Type: EXPERIMENTAL

Brushing

Intervention Type: OTHER

Brushing the teeth 2x a day for 4 weeks.

Commercial toothpaste

Brushing twice a day with a commercially available toothpaste.

Group Type: ACTIVE_COMPARATOR

Brushing

Intervention Type: OTHER

Brushing the teeth 2x a day for 4 weeks.

Interventions

Brushing

Brushing the teeth 2x a day for 4 weeks.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patients with minimum 20 teeth;

2. Good oral hygiene level (gingival bleeding index not exceeding 20%)

3. Patients willing to participate in the study and able to sign an informed consent

Exclusion Criteria

1. Tooth anomalies (amelogenesis imperfecta, dentinogenesis imperfecta etc.);

2. Intrinsic stain (fluorosis);

3. Caries lesions;

4. Advanced periodontal disease (probing >2, spontaneous gum bleeding, tooth mobility >1);

5. Smokers;

6. Use of orthodontic devices;

7. Use of antibiotics in the last 3 months;

8. Use of antibacterial mouth rinses in the last 3 months;

9. Potential allergies;

10. Drug and alcohol abuse;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Unilever R&D

INDUSTRY

Sponsor Role: collaborator

University of Bologna

OTHER

Sponsor Role: lead

Responsible Party

Lorenzo Breschi

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

DIBINEM

Bologna, BO, Italy

Countries

Italy

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2.2022.

Identifier Type: -

Identifier Source: org_study_id