Extrinsic Staining of Tooth - MedicationNCT04904978
Evaluation of Two Different Toothpastes for Clinical Management of Extrinsic Stains.
A study testing Blanx Black Toothpaste and Colgate Sensation White in people with Extrinsic Staining of Tooth - Medication, run by University of Pavia at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Extrinsic Staining of Tooth - Medication
- What is being tested?
- Blanx Black Toothpaste and Colgate Sensation White
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 28 May 2021to 12 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Presence of extrinsic stains
- Patients with high compliance
Who cannot join
- Underage patients
- Patients suffering from neurological or psychiatric disorders
- Pregnant women
- Patients undergoing anticancer chemotherapy
- Patients with low compliance
Trial locations and contacts
1 site in 1 country.
Italy1 site
Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
Pavia, Lombardy, 27100
About this study
Official title: Evaluation of Two Different Toothpastes for the Clinical Management of Extrinsic Stains: Randomized Clinical Trial.
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.
Read more
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.
Read the 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.
- Conditions
- Extrinsic Staining of Tooth - Medication
- Being tested
- Blanx Black Toothpaste, Colgate Sensation White
- Keywords
- toothpaste, extrinsic stains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blanx Black ToothpasteOther
Use of Blanx Black Toothpaste twice a day per at least 2 minutes.
Colgate Sensation WhiteOther
Use of Colgate Sensation White Toothpaste twice a day per at least 2 minutes
| Study group | Role | What they receive |
|---|---|---|
| Trial Group | Experimental | Use of Blanx Black Toothpaste Receives: Other: Blanx Black Toothpaste |
| Control Group | Active comparator | Use of Colgate Sensation White toothpaste. Receives: Other: Colgate Sensation White |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BOP - Bleeding on Probing (percentage)
Site-specific assessment of the presence or absence of gum bleeding after the insertion of the periodontal probe for the detection of PPD, detected on 6 sites.
Percentage of sites with bleeding on probing determines the BOP%.
Measured: Baseline, 10 days, 1 month, 3 months
Change in MLI - Modified Lobene Index
The facial surface of each anterior tooth was divided into two regions. The first is the gingival region which was a crescent-shaped band of the labial surface about 2 mm wide adjacent to the free margin of the gingiva and extending to the crest of the interdental papillae of the adjacent teeth. The second is the body region which constitutes the remainder of the labial surface of the tooth.
The gingival and body regions were scored separately.
Intensity - Scoring criteria:
- 0: no stain;
- 1: mild stain, from yellow to light brown or gray;
- 2: mild stain, brown colored;
- 3: heavy stain, from dark brown to black.
Area - Scoring criteria:
- 0: no stain;
- 1: 1/3 extension of the stain;
- 2: from 1/3 to 2/3 extension of the stain;
- 3: stain covering over two-thirds of the region. stain extent.
Measured: Baseline, 10 days, 1 month, 3 months
Change in Plaque Control Record (PCR%)
% assessment of the amount of plaque on dental surfaces; it is detected on 4 surfaces: distal, mesial, vestibular, lingual / palatal. The number of sites with plaque is divided by the total number of sites available in the mouth and multiplied by 100. Results indicate the index as a percentage.Scoring criteria:
- 0: no bleeding
- 1: mild bleeding
- 2: severe bleeding The number of bleeding sites is divided per the total number of probed sites; the ratio is multiplied X 100.
Measured: Baseline, 10 days, 1 month, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start28 May 2021
- Primary completion6 Apr 2022
- Study completion12 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extrinsic Staining of Tooth - MedicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Scribante, University of Pavia
- Investigators
- Andrea Scribante, DDS, PhD, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904978
- Sponsor's protocol ID
- 2021-BLANKSBLACK
- Status last verified
- Feb 2023
- First submitted
- 22 May 2021
- Last updated
- 10 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon motivated request to Principal Investigator.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Two Different Toothpastes for the Clinical Management of Extrinsic Stains: Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04904978
- Acronym / sponsor ID
- 2021-BLANKSBLACK
- Conditions
- Extrinsic Staining of Tooth - Medication
- Keywords
- toothpaste, extrinsic stains
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 28 May 2021 (actual)
- Primary completion
- 6 Apr 2022 (actual)
- Study completion
- 12 Apr 2022 (actual)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trial Group | Experimental | Other: Blanx Black ToothpasteUse of Blanx Black Toothpaste |
| Control Group | Active comparator | Other: Colgate Sensation WhiteUse of Colgate Sensation White toothpaste. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years
- Presence of extrinsic stains
- Patients with high compliance
Key exclusion criteria (5 listed)
- Underage patients
- Patients suffering from neurological or psychiatric disorders
- Pregnant women
- Patients undergoing anticancer chemotherapy
- Patients with low compliance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blanx Black ToothpasteUse of Blanx Black Toothpaste twice a day per at least 2 minutes. | Other | Trial Group |
| Colgate Sensation WhiteUse of Colgate Sensation White Toothpaste twice a day per at least 2 minutes | Other | Control Group |
Primary outcome
Change in BOP - Bleeding on Probing (percentage)
Time frame: Baseline, 10 days, 1 month, 3 months
Site-specific assessment of the presence or absence of gum bleeding after the insertion of the periodontal probe for the detection of PPD, detected on 6 sites. Percentage of sites with bleeding on probing determines the BOP%.
Change in MLI - Modified Lobene Index
Time frame: Baseline, 10 days, 1 month, 3 months
The facial surface of each anterior tooth was divided into two regions. The first is the gingival region which was a crescent-shaped band of the labial surface about 2 mm wide adjacent to the free margin of the gingiva and extending to the crest of the interdental papillae of the adjacent teeth. The second is the body region which constitutes the remainder of the labial surface of the tooth. The gingival and body regions were scored separately. Intensity - Scoring criteria: * 0: no stain; * 1: mild stain, from yellow to light brown or gray; * 2: mild stain, brown colored; * 3: heavy stain, from dark brown to black. Area - Scoring criteria: * 0: no stain; * 1: 1/3 extension of the stain; * 2: from 1/3 to 2/3 extension of the stain; * 3: stain covering over two-thirds of the region. stain extent.
Change in Plaque Control Record (PCR%)
Time frame: Baseline, 10 days, 1 month, 3 months
% assessment of the amount of plaque on dental surfaces; it is detected on 4 surfaces: distal, mesial, vestibular, lingual / palatal. The number of sites with plaque is divided by the total number of sites available in the mouth and multiplied by 100. Results indicate the index as a percentage.Scoring criteria: * 0: no bleeding * 1: mild bleeding * 2: severe bleeding The number of bleeding sites is divided per the total number of probed sites; the ratio is multiplied X 100.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Individual participant dataSharing planned: No. Data will be available upon motivated request to Principal Investigator.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Scribante, DDS, PhD principal investigator
University of Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blanx Black Toothpaste and Colgate Sensation White in people with Extrinsic Staining of Tooth - Medication, run by University of Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BOP - Bleeding on Probing (percentage) (time frame: Baseline, 10 days, 1 month, 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.