Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04865796
Status:
COMPLETED
Last Update Posted:
2022-01-31
First Post:
2021-04-26
Brief Title:
Black Stains Epidemiology Clinical Evaluation and Dietary Habits a Clinical Trial
Sponsor:
University of Pavia
Organization:
University of Pavia
Study Overview
Official Title:
Epidemiology Clinical Evaluation of Black Stains and Patients Dietary Habits a Clinical Trial
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Gasparettos 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
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 Gasparettos 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
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 Gasparettos 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 minutesday and Biorepair Peribioma toothpaste containing probiotics
Group 3 patients will choose the best product for their home oral care
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 Gasparettos 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 minutesday and Biorepair Peribioma toothpaste containing probiotics
Group 3 patients will choose the best product for their home oral care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None