Efficacy of an Antibacterial Toothpaste and Patients' Satisfaction

Study Overview
=================
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.

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

Conditions
-----------------
Caries, Gingivitis

Intervention / Treatment
-----------------
* Other: Brushing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with minimum 20 teeth; Good oral hygiene level (gingival bleeding index not exceeding 20%) Patients willing to participate in the study and able to sign an informed consent Exclusion Criteria: Tooth anomalies (amelogenesis imperfecta, dentinogenesis imperfecta etc.); Intrinsic stain (fluorosis); Caries lesions; Advanced periodontal disease (probing >2, spontaneous gum bleeding, tooth mobility >1); Smokers; Use of orthodontic devices; Use of antibiotics in the last 3 months; Use of antibacterial mouth rinses in the last 3 months; Potential allergies; Drug and alcohol abuse;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Recently introduced toothpaste<br>Brushing twice a day with a recently introduced toothpaste. | Other: Brushing<br>* Brushing the teeth 2x a day for 4 weeks.<br>|
| Active Comparator: Commercial toothpaste<br>Brushing twice a day with a commercially available toothpaste. | Other: Brushing<br>* Brushing the teeth 2x a day for 4 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 |