Evaluation of Two Different Toothpastes for Clinical Management of Extrinsic Stains.

Study Overview
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Brief Summary
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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: 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, collecting again the indices and improving home oral care.

Detailed Description
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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.

Official Title
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Evaluation of Two Different Toothpastes for the Clinical Management of Extrinsic Stains: Randomized Clinical Trial.

Conditions
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Extrinsic Staining of Tooth - Medication

Intervention / Treatment
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* Other: Blanx Black Toothpaste
* Other: Colgate Sensation White


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Presence of extrinsic stains Patients with high compliance Exclusion Criteria: Underage patients Patients suffering from neurological or psychiatric disorders Pregnant women Patients undergoing anticancer chemotherapy Patients with low compliance

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trial Group<br>Use of Blanx Black Toothpaste | Other: Blanx Black Toothpaste<br>* Use of Blanx Black Toothpaste twice a day per at least 2 minutes.<br>|
| Active Comparator: Control Group<br>Use of Colgate Sensation White toothpaste. | Other: Colgate Sensation White<br>* Use of Colgate Sensation White Toothpaste twice a day per at least 2 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BOP - Bleeding on Probing (percentage) | 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. Percentage of sites with bleeding on probing determines the BOP%. | Baseline, 10 days, 1 month, 3 months | 
| Change in MLI - Modified Lobene Index | 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. | Baseline, 10 days, 1 month, 3 months | 
| Change in Plaque Control Record (PCR%) | % assessment of the amount of plaque on dental surfaces; it is detected on 4 surfaces: distal, mesial, vestibular, lingual / palatal. The number of sites with plaque is divided by the total number of sites available in the mouth and multiplied by 100. Results indicate the index as a percentage.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. | Baseline, 10 days, 1 month, 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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toothpaste, extrinsic stains