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| Name | Class |
|---|---|
| Unilever R&D | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recently introduced toothpaste | Experimental | Brushing twice a day with a recently introduced toothpaste. |
|
| Commercial toothpaste | Active Comparator | Brushing twice a day with a commercially available toothpaste. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brushing | Other | Brushing the teeth 2x a day for 4 weeks. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DIBINEM | Bologna | BO | 40125 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39572408 | Derived | Josic U, Maravic T, Mazzitelli C, Rinaldi L, D'Alessandro C, D'Urso D, Pellegrino G, Mazzoni A, Breschi L. The clinical and microbiological efficacy of a zinc-citrate/hydroxyapatite/potassium-citrate containing toothpaste: a double-blind randomized controlled clinical trial. Clin Oral Investig. 2024 Nov 22;28(12):652. doi: 10.1007/s00784-024-06052-z. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Recently Introduced Toothpaste | Brushing twice a day with a recently introduced toothpaste. Brushing: Brushing the teeth 2x a day for 4 weeks. |
| FG001 | Commercial Toothpaste | Brushing twice a day with a commercially available toothpaste. Brushing: Brushing the teeth 2x a day for 4 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Recently Introduced Toothpaste | Brushing twice a day with a recently introduced toothpaste. Brushing: Brushing the teeth 2x a day for 4 weeks. |
| BG001 | Commercial Toothpaste | Brushing twice a day with a commercially available toothpaste. Brushing: Brushing the teeth 2x a day for 4 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | log CFU/ml | 4 weeks |
|
Up to 4 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Recently Introduced Toothpaste | Brushing twice a day with a recently introduced toothpaste. Brushing: Brushing the teeth 2x a day for 4 weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Lorenzo Breschi | DIBINE, University of Bologna | +393482210664 | lorenzo.breschi@unibo.it |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 20, 2024 | Nov 20, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 20, 2024 | Nov 20, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D014099 | Toothbrushing |
| ID | Term |
|---|---|
| D009910 | Oral Hygiene |
| D011313 | Preventive Dentistry |
| D003813 | Dentistry |
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| 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. 1 = "Not satisfied at all" and 10 = "Very satisfied" | 4 weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Potential patients were recruited through local advertisement or on-site, during routine dental check-ups within the Dental Clinic (DIBINEM, University of Bologna, Italy). | There was a drop-out of patients. | Number | participants |
|
| OG001 | Commercial Toothpaste | Brushing twice a day with a commercially available toothpaste. Brushing: Brushing the teeth 2x a day for 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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; | Posted | Mean | Standard Deviation | units on a scale | 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. 1 = "Not satisfied at all" and 10 = "Very satisfied" | Posted | Median | Standard Deviation | units on a scale | 4 weeks |
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|
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Commercial Toothpaste | Brushing twice a day with a commercially available toothpaste. Brushing: Brushing the teeth 2x a day for 4 weeks. | 0 | 50 | 0 | 50 | 0 | 50 |
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| D009057 |
| Stomatognathic Diseases |