Clinical trial NCT04904978: Evaluation of Two Different Toothpastes for Clinical Management of Extrinsic Stains.
Official title: Evaluation of Two Different Toothpastes for the Clinical Management of Extrinsic Stains: Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Extrinsic Staining of Tooth - Medication
Keywords: toothpaste
extrinsic stains
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2021-05-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to assess the efficacy of Blanx Black Toothpaste against extrinsic stains of teeth.

Patients who sign the informed consent will participate to the study.

At the baseline, the collection of Plaque Index, modified Lobene index and Bleeding Index will be performed, giving the instruction for a proper home oral hygiene. Professional supragingival and subgingival dental hygiene with piezoelectric will be performed. Then, patients will be randomly divided into two groups:

* Trial Group will use Blanx Black Toothpaste (2 minutes brushing) twice a day for the all the study duration;
* Control Group will use Colgate Sensation White Toothpaste (2 minutes brushing) twice a day.

Patients will be reevaluated after 10 days, after 1 month and after 3 months, collecting again the indices and improving home oral care.

Detailed description: The aim of the study is to assess the efficacy of Blanx Black Toothpaste against extrinsic stains of teeth.

For this purpose, patients addressing to the Dental Hygiene Unit that agree to participate to the study will be enrolled after signing the informed consent.

At the baseline, the collection of Plaque Index, modified Lobene index and Bleeding Index will be performed, giving the instruction for a proper home oral hygiene. Professional supragingival and subgingival dental hygiene with piezoelectric will be performed. Then, patients will be randomly divided into two groups:

* Trial Group will use Blanx Black Toothpaste (2 minutes brushing) twice a day for the all the study duration;
* Control Group will use Colgate Sensation White Toothpaste (2 minutes brushing) twice a day.

Patients will be reevaluated after 10 days, after 1 month and after 3 months. After the reinforcement of home oral hygiene, the above mentioned indices will be collected.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Presence of extrinsic stains
* Patients with high compliance

Exclusion Criteria:

* Underage patients
* Patients suffering from neurological or psychiatric disorders
* Pregnant women
* Patients undergoing anticancer chemotherapy
* Patients with low compliance

Primary outcomes:
measure: Change in BOP - Bleeding on Probing (percentage)
timeFrame: Baseline, 10 days, 1 month, 3 months
measure: Change in MLI - Modified Lobene Index
timeFrame: Baseline, 10 days, 1 month, 3 months
measure: Change in Plaque Control Record (PCR%)
timeFrame: Baseline, 10 days, 1 month, 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
state: Lombardy
Study officials:
affiliation: University of Pavia
name: Andrea Scribante, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: