Sponsor study identifier
interventional
40
1 country
1
Study Start
May 28, 2021
Actual (reported)Primary Completion
April 6, 2022
Actual (reported)Study Completion
April 12, 2022
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 12, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 22, 2021
Actual (reported)May 27, 2021
Actual (reported)May 28, 2021
Actual (reported)April 6, 2022
Actual (reported)April 12, 2022
Actual (reported)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
Use of Blanx Black Toothpaste
Use of Colgate Sensation White toothpaste.
Use of Blanx Black Toothpaste twice a day per at least 2 minutes.
Use of Colgate Sensation White Toothpaste twice a day per at least 2 minutes
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
Pavia, Lombardy, 27100, Italy
Andrea Scribante, DDS, PhD
University of Pavia
40 participants (actual enrollment reported by the registry).
First Submitted
May 22, 2021
First Posted
May 27, 2021
Study Start
May 28, 2021
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
April 6, 2022
Actual (reported)Study Completion
April 12, 2022
Actual (reported)Last Updated
February 10, 2023
Record last verified: 2023-02
Data will be available upon motivated request to Principal Investigator.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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