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CompletedNCT04904978Updated Feb 10, 2023

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

An interventional study of Blanx Black Toothpaste and Colgate Sensation White in Extrinsic Staining of Tooth - Medication, sponsored by University of Pavia. Completed at 1 site in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-02-10.

Sponsored by University of Pavia · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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:

  • 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.

Read the 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.

02

Conditions studied

  • Extrinsic Staining of Tooth - Medication

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Keywords

  • toothpaste
  • extrinsic stains
03

In context

Tooth Discoloration

102 studies on the registry are indexed under Tooth Discoloration; 19 are open to participants now.

This study's enrollment of 40 is below the median of 48 across 95 interventional studies indexed under Tooth Discoloration.

Browse Tooth Discoloration studies →

Lead sponsor

University of Pavia is the lead sponsor of 141 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age > 18 years
  • Presence of extrinsic stains
  • Patients with high compliance

Exclusion criteria

Exclusion Criteria:

  • Underage patients
  • Patients suffering from neurological or psychiatric disorders
  • Pregnant women
  • Patients undergoing anticancer chemotherapy
  • Patients with low compliance
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Trial Group

    Use of Blanx Black Toothpaste

    Other: Blanx Black Toothpaste

  • Active comparator
    Control Group

    Use of Colgate Sensation White toothpaste.

    Other: Colgate Sensation White

Interventions

  • OtherBlanx Black Toothpaste

    Use of Blanx Black Toothpaste twice a day per at least 2 minutes.

  • OtherColgate Sensation White

    Use of Colgate Sensation White Toothpaste twice a day per at least 2 minutes

06

What researchers measure

Primary outcomes

  1. 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%.

    Time frame: Baseline, 10 days, 1 month, 3 months

  2. 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.

    Time frame: Baseline, 10 days, 1 month, 3 months

  3. 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.

    Time frame: Baseline, 10 days, 1 month, 3 months

07

Study locations

1 site
  • Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
    Pavia, Lombardy 27100, Italy
08

References and documents

Individual participant data

Plan to share: No — Data will be available upon motivated request to Principal Investigator.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04904978
Lead sponsor
University of Pavia
Responsible party
Andrea Scribante (Research Resident, Principal Investigator, University of Pavia) — Principal investigator
First posted
May 27, 2021
Start date
May 28, 2021
Primary completion
Apr 6, 2022
Completion
Apr 12, 2022
Last update
Feb 10, 2023

Study contacts

Andrea Scribante, DDS, PhD
principal investigator · University of Pavia

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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