Efficacy of an Antibacterial Toothpaste and Patients' Satisfaction

Gingivitis Clinical Trial

Official title:

In Vivo Evaluation of Antibacterial Toothpaste Efficiency and Patients' Satisfaction: a Double-blind Randomised Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05569850
• Other study ID #: 2.2022.
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: December 20, 2022

Study information

• Verified date: October 2022
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 20, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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;

Related Conditions & MeSH terms

• Caries
• Gingivitis

Intervention

Other:
• Brushing
Brushing the teeth 2x a day for 4 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Bologna	Unilever R&D

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacterial count of Streptococcus mutans (S. mutans)	Agar Mitis salivarius with tellurium and bacitracin (MSTB) will be used for S. mutans isolation. The 0.1 ml saliva sample will be diluted with 0.9 ml of sterile normal saline; next, decimal dilutions of saliva will be made up to 10-3. Each medium plate will be cultured from 0.1 ml of the previously diluted sample to 10-3; then, the sample will be uniformly spread on the agar plates. Finally, the plates will be sealed. They will be incubated for 48 hours at 37°C. The bacterial colonies will be observed under a stereo microscope and identified by morphology and color. The CFU will be multiplied by the number of times the sample was originally diluted and expressed as the number of colony forming units per millilitre (CFU/mL) of saliva.	4 weeks
Secondary	Plaque index	The plaque will be disclosed using a disclosing solution and recorded as follows: score 0 = absence of plaque; score 1 = separate flecks of plaque on the cervical margin; score 2 = a thin, continuous band of plaque [up to 1 mm] at the cervical margin of the tooth; score 3 = a band of plaque wider than 1 mm, but covering less than one-third of the tooth crown; score 4 = plaque covering at least one-third, but less than two-third of the crown of the tooth; score 5 = plaque covering 2/3-crown or more of the crown of the tooth.	4 weeks
Secondary	Gingival index	A North Carolina periodontal probe (Hu-Friedy, Chicago, IL, USA) will be used for determine gingival index according to the following scale: score 0 = absence of inflammation; score 1 = mild inflammation-slightly slight change in color and little change in texture; score 2 = moderate inflammation-moderate glazing, redness, edema, and hypertrophy; score 3 = severe inflammation-marked redness and hypertrophy.	4 weeks
Secondary	Dentin hypersensitivity	Patients with self-reported dentin hypersensitivity will be considered. A 1-s air blast from approximately 1 cm distance will be applied onto exposed dentine. The participant's response will be assessed using the 4-point Schiff Sensitivity Scale (from 0: participant does not respond, to 3: participant responds to stimulus, considers it painful, and requests discontinuation;	4 weeks
Secondary	Tooth colour	Participants' satisfaction before and after treatment will be recorded and the difference will be assessed. In order to obtain the data concerning patients' satisfaction with tooth color, a questionnaire containing aesthetic numeric visual-analogue scale ranging from 1 to 10 will be given to the subjects.	4 weeks