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

Overview

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.

Full Title of Study: “Epidemiology, Clinical Evaluation of Black Stains and Patients’ Dietary Habits: a Clinical Trial.”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Study Primary Completion Date: January 13, 2022

Detailed Description

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.

Interventions

• Other: Lactoferrin products
  • Patiens will use a toothpaste and 2 tablets per day (between foods) for home oral care.
• Other: Probiotics products
  • Patiens will use a toothpaste and a chewing-gum (for 10 minutes a day) for home oral care.
• Other: Standard home oral care
  • Patiens will use a normal toothpaste for home oral care.

Arms, Groups and Cohorts

• Experimental: Group 1
  • Patients will use products based on lactoferrin.
• Experimental: Probiotics
  • Patients will use products based on probiotics for home oral care.
• Active Comparator: Standard therapy
  • Patients will use standard toothpastes for home oral care.

Clinical Trial Outcome Measures

Primary Measures

• 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 Measures

• 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.
• 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.
• 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • University of Pavia
• Provider of Information About this Clinical Study
  • Principal Investigator: Andrea Scribante, Research Resident, Principal Investigator – University of Pavia
• Overall Official(s)
  • Andrea Scribante, DDS, PhD., Principal Investigator, University of Pavia