Black StainsNCT04865796
Black Stains' Epidemiology, Clinical Evaluation and Dietary Habits: a Clinical Trial.
A study testing Lactoferrin products, Probiotics products and Standard home oral care in people with Black Stains, run by University of Pavia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Black Stains
- What is being tested?
- Lactoferrin products, Probiotics products and Standard home oral care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- 15 May 2021to 16 Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with black stains
- Patients with high compliance
Who cannot join
- Patients suffering from psychological, neurological or psychiatric disorders
- Pregnant or breastfeeding women
- Patients undergoing anti-cancer therapy
- 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: Epidemiology, Clinical Evaluation of Black Stains and Patients' Dietary Habits: a Clinical Trial.
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 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.
Read the 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 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
- Black Stains
- Being tested
- Lactoferrin products, Probiotics products, Standard home oral care
- Keywords
- Oral microbiota, Periodontal bacteria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactoferrin productsOther
Patiens will use a toothpaste and 2 tablets per day (between foods) for home oral care.
Probiotics productsOther
Patiens will use a toothpaste and a chewing-gum (for 10 minutes a day) for home oral care.
Standard home oral careOther
Patiens will use a normal toothpaste for home oral care.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Patients will use products based on lactoferrin. Receives: Other: Lactoferrin products |
| Probiotics | Experimental | Patients will use products based on probiotics for home oral care. Receives: Other: Probiotics products |
| Standard therapy | Active comparator | Patients will use standard toothpastes for home oral care. Receives: Other: Standard home oral care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the extension of black stains (Gasparetto et al., 2003)
Scoring criteria:
- 1: presence of pigmented dots or thin lines with incomplete coalescence parallel to gingival margin;
- 2: continuous pigmented lines, which can be easily observed and limited to half of the cervical third of the tooth surface;
- 3: presence of pigmented stains extending beyond half of the cervical third of the tooth surface
Measured: Study begin, 2 and 6 months.
Secondary outcomes (3)
Change in DMFT (Decayed Missing Filled Teeth) score
It's the measure of caries experience worldwide. This index gives the sum of an individual's decayed, missing, and filled permanent teeth. It ranges from 0 to 32 (including the wisdom teeth). The higher the score, the worst the oral health condition of the patient.
Measured: Study begin, 2 and 6 months.
Change in DMFS (Decayed Missing Filled Surfaces) score
It's the measure of caries experience worldwide. This index gives the sum of an individual's decayed, missing, and filled permanent surfaces. It ranges from 0 to 148 (including the wisdom teeth). The higher the score, the worst the oral health condition of the patient.
Measured: Study begin, 2 and 6 months.
Dietary habits
Patients will ask to assess if there is a consumption of the following foods and drinks ≤ 3 times /months, ≤ 6/week, ≥ 1/day:
Beet Swiss chard Broccoli Candies Meat Cabbage Desserts Fresh fruit Dairy product Legumes Spinach Eggs Vegetable Coffee Coca Cola Natural juices Red juices The Red wine
Measured: Study begin, 2 and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start15 May 2021
- Primary completion13 Jan 2022
- Study completion16 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Black StainsStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 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
- NCT04865796
- Sponsor's protocol ID
- 2021-BLACKSTAINS
- Status last verified
- Jan 2022
- First submitted
- 26 Apr 2021
- Last updated
- 31 Jan 2022
- 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 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology, Clinical Evaluation of Black Stains and Patients' Dietary Habits: a Clinical Trial.
- ClinicalTrials.gov ID
- NCT04865796
- Acronym / sponsor ID
- 2021-BLACKSTAINS
- Conditions
- Black Stains
- Keywords
- Oral microbiota, Periodontal bacteria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 13 Jan 2022 (actual)
- Study completion
- 16 Jan 2022 (actual)
- First posted
- 29 Apr 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 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 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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Lactoferrin productsPatients will use products based on lactoferrin. |
| Probiotics | Experimental | Other: Probiotics productsPatients will use products based on probiotics for home oral care. |
| Standard therapy | Active comparator | Other: Standard home oral carePatients will use standard toothpastes for home oral care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients with black stains
- Patients with high compliance
Key exclusion criteria (4 listed)
- Patients suffering from psychological, neurological or psychiatric disorders
- Pregnant or breastfeeding women
- Patients undergoing anti-cancer therapy
- 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 |
|---|---|---|
| Lactoferrin productsPatiens will use a toothpaste and 2 tablets per day (between foods) for home oral care. | Other | Group 1 |
| Probiotics productsPatiens will use a toothpaste and a chewing-gum (for 10 minutes a day) for home oral care. | Other | Probiotics |
| Standard home oral carePatiens will use a normal toothpaste for home oral care. | Other | Standard therapy |
Primary outcome
Change in the extension of black stains (Gasparetto et al., 2003)
Time frame: Study begin, 2 and 6 months.
Scoring criteria: * 1: presence of pigmented dots or thin lines with incomplete coalescence parallel to gingival margin; * 2: continuous pigmented lines, which can be easily observed and limited to half of the cervical third of the tooth surface; * 3: presence of pigmented stains extending beyond half of the cervical third of the tooth surface
3 secondary outcomes
Change in DMFT (Decayed Missing Filled Teeth) score
Time frame: Study begin, 2 and 6 months.
Change in DMFS (Decayed Missing Filled Surfaces) score
Time frame: Study begin, 2 and 6 months.
Dietary habits
Time frame: Study begin, 2 and 6 months.
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 31 Jan 2022.
- Individual participant dataSharing planned: No. Data will be available upon motivated request to Principal Investigator
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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 Lactoferrin products, Probiotics products and Standard home oral care in people with Black Stains, 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 2 inclusion and 4 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 31 Jan 2022. 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 the extension of black stains (Gasparetto et al., 2003) (time frame: Study begin, 2 and 6 months.). 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 31 Jan 2022.