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Completed

NCT Number: NCT04865796

Black Stains' Epidemiology, Clinical Evaluation and Dietary Habits: a Clinical Trial.

The aim of this study is to investigate epidemiology and treatment possibilities of black stains, with the assessment of a possible correlation with patients' dietary habits.

Patients will be randomly divided into three groups. For each group, clinical evaluation will be performed at the study begin, after 2 and after 6 months.

At the study begin, evaluation of black stains with Gasparetto's classification will be assessed; then professional oral hygiene with ultrasonic scaler will be performed, plus glycine and polish; then, products for home oral care will be given to patients, depending on the groups. The clinical situation will be re-evaluated after 2 and after 6 months. Home oral care will be performed with different products, containing lactoferrin (group 1) and probiotics (group 2). The control group (Group 3) will use normal products.

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Key information

Conditions

Black Stains

Age range

18 year and older

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 this study is to investigate epidemiology and treatment possibilities of black stains, with the assessment of a possible correlation with patients' dietary habits.

Patients will be randomly divided into three groups. For each group, clinical evaluation will be performed at the study begin, after 2 and after 6 months.

At the study begin, evaluation of black stains with Gasparetto's classification will be assessed; then professional oral hygiene with ultrasonic scaler will be performed, plus glycine and polish; then, products for home oral care will be given to patients, depending on the groups. The clinical situation will be re-evaluated after 2 and after 6 months.

Home oral care will be performed as follows:

  • Group 1: patients will use 2 Forhans GengiFor tables (between foods) and Forhans Scudo Naturale toothpaste containing lactoferrin.
  • Group 2: patients will use Biorepair Peribioma chewing-gum for 10 minutes/day and Biorepair Peribioma toothpaste containing probiotics.
  • Group 3: patients will choose the best product for their home oral care.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients with black stains
  • Patients with high compliance

Exclusion criteria

  • Patients suffering from psychological, neurological or psychiatric disorders
  • Pregnant or breastfeeding women
  • Patients undergoing anti-cancer therapy
  • Patients with low compliance

Treatment and study plan

Lactoferrin products

Other

Patiens will use a toothpaste and 2 tablets per day (between foods) for home oral care.

Probiotics products

Other

Patiens will use a toothpaste and a chewing-gum (for 10 minutes a day) for home oral care.

Standard home oral care

Other

Patiens will use a normal toothpaste for home oral care.

Primary outcomes

  1. Change in the extension of black stains (Gasparetto et al., 2003)

    Time frame: Study begin, 2 and 6 months.

    Scoring criteria:

    • 1: presence of pigmented dots or thin lines with incomplete coalescence parallel to gingival margin;
    • 2: continuous pigmented lines, which can be easily observed and limited to half of the cervical third of the tooth surface;
    • 3: presence of pigmented stains extending beyond half of the cervical third of the tooth surface

Secondary outcomes

  1. Change in DMFT (Decayed Missing Filled Teeth) score

    Time frame: Study begin, 2 and 6 months.

    It's the measure of caries experience worldwide. This index gives the sum of an individual's decayed, missing, and filled permanent teeth. It ranges from 0 to 32 (including the wisdom teeth). The higher the score, the worst the oral health condition of the patient.

  2. Change in DMFS (Decayed Missing Filled Surfaces) score

    Time frame: Study begin, 2 and 6 months.

    It's the measure of caries experience worldwide. This index gives the sum of an individual's decayed, missing, and filled permanent surfaces. It ranges from 0 to 148 (including the wisdom teeth). The higher the score, the worst the oral health condition of the patient.

  3. Dietary habits

    Time frame: Study begin, 2 and 6 months.

    Patients will ask to assess if there is a consumption of the following foods and drinks ≤ 3 times /months, ≤ 6/week, ≥ 1/day:

    Beet Swiss chard Broccoli Candies Meat Cabbage Desserts Fresh fruit Dairy product Legumes Spinach Eggs Vegetable Coffee Coca Cola Natural juices Red juices The Red wine

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Registry information

Official study title

Epidemiology, Clinical Evaluation of Black Stains and Patients' Dietary Habits: a Clinical Trial.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 29, 2021
Registry last updated
Jan 31, 2022

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.

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