Evaluation of Two Different Toothpastes for Clinical Management of Extrinsic Stains.
Study Details
Study Description
Brief Summary
The aim of the study is to assess the efficacy of Blanx Black Toothpaste against extrinsic stains of teeth.
Patients who sign the informed consent will participate to the study.
At the baseline, the collection of Plaque Index, modified Lobene index and Bleeding Index will be performed, giving the instruction for a proper home oral hygiene. Professional supragingival and subgingival dental hygiene with piezoelectric will be performed. Then, patients will be randomly divided into two groups:
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Trial Group will use Blanx Black Toothpaste (2 minutes brushing) twice a day for the all the study duration;
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Control Group will use Colgate Sensation White Toothpaste (2 minutes brushing) twice a day.
Patients will be reevaluated after 10 days, after 1 month and after 3 months, collecting again the indices and improving home oral care.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The aim of the study is to assess the efficacy of Blanx Black Toothpaste against extrinsic stains of teeth.
For this purpose, patients addressing to the Dental Hygiene Unit that agree to participate to the study will be enrolled after signing the informed consent.
At the baseline, the collection of Plaque Index, modified Lobene index and Bleeding Index will be performed, giving the instruction for a proper home oral hygiene. Professional supragingival and subgingival dental hygiene with piezoelectric will be performed. Then, patients will be randomly divided into two groups:
-
Trial Group will use Blanx Black Toothpaste (2 minutes brushing) twice a day for the all the study duration;
-
Control Group will use Colgate Sensation White Toothpaste (2 minutes brushing) twice a day.
Patients will be reevaluated after 10 days, after 1 month and after 3 months. After the reinforcement of home oral hygiene, the above mentioned indices will be collected.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Trial Group Use of Blanx Black Toothpaste |
Other: Blanx Black Toothpaste
Use of Blanx Black Toothpaste twice a day per at least 2 minutes.
|
| Active Comparator: Control Group Use of Colgate Sensation White toothpaste. |
Other: Colgate Sensation White
Use of Colgate Sensation White Toothpaste twice a day per at least 2 minutes
|
Outcome Measures
Primary Outcome Measures
- Change in PI - Plaque Index (percentage) [Baseline, 10 days, 1 month, 3 months]
Evaluation of the presence of plaque with a disclosing agent on the 4 surfaces of teeth on the total amount of dental surfaces multiplied per 100.
- Change in MLI - Modified Lobene Index [Baseline, 10 days, 1 month, 3 months]
The facial surface of each anterior tooth was divided into two regions. The first is the gingival region which was a crescent-shaped band of the labial surface about 2 mm wide adjacent to the free margin of the gingiva and extending to the crest of the interdental papillae of the adjacent teeth. The second is the body region which constitutes the remainder of the labial surface of the tooth. The gingival and body regions were scored separately. Intensity - Scoring criteria: 0: no stain; 1: mild stain, from yellow to light brown or gray; 2: mild stain, brown colored; 3: heavy stain, from dark brown to black. Area - Scoring criteria: 0: no stain; 1: 1/3 extension of the stain; 2: from 1/3 to 2/3 extension of the stain; 3: stain covering over two-thirds of the region. stain extent.
- Change in BI - Bleeding Index [Baseline, 10 days, 1 month, 3 months]
Site-specific assessment of the presence or absence of gum bleeding after the insertion of the periodontal probe for the detection of PPD, detected on 6 sites and recorded after 30 seconds from the insertion of the probe. Scoring criteria: 0: no bleeding 1: mild bleeding 2: severe bleeding The number of bleeding sites is divided per the total number of probed sites; the ratio is multiplied X 100.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age > 18 years
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Presence of extrinsic stains
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Patients with high compliance
Exclusion Criteria:
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Underage patients
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Patients suffering from neurological or psychiatric disorders
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Pregnant women
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Patients undergoing anticancer chemotherapy
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Patients with low compliance
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia | Pavia | Lombardy | Italy | 27100 |
Sponsors and Collaborators
- University of Pavia
Investigators
- Principal Investigator: Andrea Scribante, DDS, PhD, University of Pavia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021-BLANKSBLACK