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

NCT04865796 | Completed

• 1 other identifier: 2021-BLACKSTAINS
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Black Stains

Keywords

Oral microbiota; Periodontal bacteria

Outcome Measures

Primary Outcomes (1)

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

  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

  Study begin, 2 and 6 months.

Secondary Outcomes (3)

• Change in DMFT (Decayed Missing Filled Teeth) score

  Study begin, 2 and 6 months.

• Change in DMFS (Decayed Missing Filled Surfaces) score

  Study begin, 2 and 6 months.

• Dietary habits

  Study begin, 2 and 6 months.

Study Arms (3)

Group 1

EXPERIMENTAL

Patients will use products based on lactoferrin.

Other: Lactoferrin products

Probiotics

EXPERIMENTAL

Patients will use products based on probiotics for home oral care.

Other: Probiotics products

Standard therapy

ACTIVE COMPARATOR

Patients will use standard toothpastes for home oral care.

Other: Standard home oral care

Interventions

Lactoferrin products OTHER

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

Group 1

Probiotics products OTHER

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

Probiotics

Standard home oral care OTHER

Patiens will use a normal toothpaste for home oral care.

Standard therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with black stains
• Patients with high compliance

You may not qualify if:

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

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

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

Pavia, Lombardy, 27100, Italy

Location

Study Officials

• Andrea Scribante, DDS, PhD.

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Resident, Principal Investigator

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: April 29, 2021
• Study Start: May 15, 2021
• Primary Completion: January 13, 2022
• Study Completion: January 16, 2022
• Last Updated: January 31, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)