Efficacy of an Antibacterial Toothpaste and Patients' Satisfaction

University of Bologna

Status: Completed

Conditions: Caries; Gingivitis

Treatments: Other: Brushing

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05569850

2.2022.

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Recently introduced toothpaste

Experimental group

Description:

Brushing twice a day with a recently introduced toothpaste.

Treatment:

Other: Brushing

Commercial toothpaste

Active Comparator group

Description:

Brushing twice a day with a commercially available toothpaste.

Treatment:

Other: Brushing