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

February 9, 2023 updated by: Andrea Scribante, University of Pavia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in BOP - Bleeding on Probing (percentage)
Time Frame: 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.

Percentage of sites with bleeding on probing determines the BOP%.
Baseline, 10 days, 1 month, 3 months
Change in MLI - Modified Lobene Index
Time Frame: 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.
Baseline, 10 days, 1 month, 3 months
Change in Plaque Control Record (PCR%)
Time Frame: Baseline, 10 days, 1 month, 3 months

% 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 28, 2021

Primary Completion (ACTUAL)

April 6, 2022

Study Completion (ACTUAL)

April 12, 2022

Study Registration Dates

First Submitted

May 22, 2021

First Submitted That Met QC Criteria

May 26, 2021

First Posted (ACTUAL)

May 27, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2023

Last Update Submitted That Met QC Criteria

February 9, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-BLANKSBLACK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be available upon motivated request to Principal Investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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