Caries, Gingivitis
Conditions
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.
Interventions
OTHERBrushing
Brushing the teeth 2x a day for 4 weeks.
Sponsors
Unilever R&D
University of Bologna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bacterial Count of Streptococcus Mutans (S. Mutans) | 4 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plaque Index | 4 weeks | 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. |
| Gingival Index | 4 weeks | 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. |
| Dentin Hypersensitivity | 4 weeks | 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; |
| Tooth Colour | 4 weeks | 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. 1 = Not satisfied at all and 10 = Very satisfied |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Recently Introduced Toothpaste Brushing twice a day with a recently introduced toothpaste.
Brushing: Brushing the teeth 2x a day for 4 weeks. | 50 |
| Commercial Toothpaste Brushing twice a day with a commercially available toothpaste.
Brushing: Brushing the teeth 2x a day for 4 weeks. | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Commercial Toothpaste | Total | Recently Introduced Toothpaste |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants | 100 Participants | 50 Participants |
| Age, Continuous | 25.3 years STANDARD_DEVIATION 0.4 | 25.5 years STANDARD_DEVIATION 0.35 | 25.7 years STANDARD_DEVIATION 0.3 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Italy | 39 participants | 85 participants | 46 participants |
| Sex: Female, Male Female | 26 Participants | 55 Participants | 29 Participants |
| Sex: Female, Male Male | 24 Participants | 45 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
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.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Recently Introduced Toothpaste | Bacterial Count of Streptococcus Mutans (S. Mutans) | 4.261 log CFU/ml | Standard Deviation 0.0867 |
| Commercial Toothpaste | Bacterial Count of Streptococcus Mutans (S. Mutans) | 4.277 log CFU/ml | Standard Deviation 0.0931 |
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;
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Recently Introduced Toothpaste | Dentin Hypersensitivity | 0.19 units on a scale | Standard Deviation 0.1 |
| Commercial Toothpaste | Dentin Hypersensitivity | 0.2 units on a scale | Standard Deviation 0.1 |
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.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Recently Introduced Toothpaste | Gingival Index | 0 score on a scale | Standard Deviation 0 |
| Commercial Toothpaste | Gingival Index | 0 score on a scale | Standard Deviation 0 |
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.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Recently Introduced Toothpaste | Plaque Index | 0.1 score on a scale | Standard Deviation 0.05 |
| Commercial Toothpaste | Plaque Index | 0.17 score on a scale | Standard Deviation 0.1 |
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. 1 = Not satisfied at all and 10 = Very satisfied
Time frame: 4 weeks
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Recently Introduced Toothpaste | Tooth Colour | 8 units on a scale | Standard Deviation 0.5 |
| Commercial Toothpaste | Tooth Colour | 7.8 units on a scale | Standard Deviation 0.5 |