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OpenTrials
Completed

NCT Number: NCT04904978

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

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.

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Key information

Conditions

Extrinsic Staining of Tooth - Medication

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Pavia, Lombardy, 27100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blanx Black Toothpaste

Other

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

Colgate Sensation White

Other

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

Primary outcomes

  1. 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%.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 27, 2021
Registry last updated
Feb 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.