Black Stains' Epidemiology, Clinical Evaluation and Dietary Habits: a Clinical Trial.
NCT ID: NCT04865796
Last Updated: 2022-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
45 participants
INTERVENTIONAL
2021-05-15
2022-01-16
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group 1
Patients will use products based on lactoferrin.
Lactoferrin products
Patiens will use a toothpaste and 2 tablets per day (between foods) for home oral care.
Probiotics
Patients will use products based on probiotics for home oral care.
Probiotics products
Patiens will use a toothpaste and a chewing-gum (for 10 minutes a day) for home oral care.
Standard therapy
Patients will use standard toothpastes for home oral care.
Standard home oral care
Patiens will use a normal toothpaste for home oral care.
Interventions
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Lactoferrin products
Patiens will use a toothpaste and 2 tablets per day (between foods) for home oral care.
Probiotics products
Patiens will use a toothpaste and a chewing-gum (for 10 minutes a day) for home oral care.
Standard home oral care
Patiens will use a normal toothpaste for home oral care.
Eligibility Criteria
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Inclusion Criteria
* Patients with high compliance
Exclusion Criteria
* Pregnant or breastfeeding women
* Patients undergoing anti-cancer therapy
* Patients with low compliance
18 Years
ALL
No
Sponsors
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University of Pavia
OTHER
Responsible Party
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Andrea Scribante
Research Resident, Principal Investigator
Principal Investigators
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Andrea Scribante, DDS, PhD.
Role: PRINCIPAL_INVESTIGATOR
University of Pavia
Locations
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Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
Pavia, Lombardy, Italy
Countries
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Other Identifiers
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2021-BLACKSTAINS
Identifier Type: -
Identifier Source: org_study_id
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