Evaluation of Two Different Toothpastes for Clinical Management of Extrinsic Stains.

NCT ID: NCT04904978

Last Updated: 2023-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-28

Study Completion Date

2022-04-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Extrinsic Staining of Tooth - Medication

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Trial Group

Use of Blanx Black Toothpaste

Group Type EXPERIMENTAL

Blanx Black Toothpaste

Intervention Type OTHER

Use of Blanx Black Toothpaste twice a day per at least 2 minutes.

Control Group

Use of Colgate Sensation White toothpaste.

Group Type ACTIVE_COMPARATOR

Colgate Sensation White

Intervention Type OTHER

Use of Colgate Sensation White Toothpaste twice a day per at least 2 minutes

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Blanx Black Toothpaste

Use of Blanx Black Toothpaste twice a day per at least 2 minutes.

Intervention Type OTHER

Colgate Sensation White

Use of Colgate Sensation White Toothpaste twice a day per at least 2 minutes

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Pavia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Andrea Scribante

Research Resident, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Andrea Scribante, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pavia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Pavia, Lombardy, Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021-BLANKSBLACK

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Dentinal Hypersensitivity Reduction
NCT06244290 COMPLETED PHASE3
Clinical Study to Evaluate Dental Plaque
NCT00758290 COMPLETED PHASE3