Molar Incisor HypomineralizationNCT04808180
Clinical Efficacy of Biomimetic Hydroxyapatite in the Treatment of Molar Incisor Hypomineralization.
A study testing Biorepair Shock Treatment and No treatment in people with Molar Incisor Hypomineralization, run by University of Pavia at 1 site in Italy.
Trial summary
The aim of the following study is to evaluate che clinical efficacy of a toothpaste with biomimetic hydroxyapatite for the management of Molar-Incisor Hypomineralization. Patients who agree to participate to the study will use Biorepair toothpaste for the first 7 days of the month for 3, 6 and 9 months. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Molar Incisor Hypomineralization
- What is being tested?
- Biorepair Shock Treatment and No treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 25 Mar 2021to 1 Feb 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- presence of at least 2 enamel demineralizations of permanent molars and incisors (Molar-Incisor Hypomineralization - MIH) in contralateral quadrants
- good general health (absence of systemic diseases)
Who cannot join
- patients undergoing orthodontic therapy
- patients taking drugs
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: Effects of Biomimetic Hydroxyapatite in the Treatment of Molar Incisor Hypomineralization: a Randomized Clinical Trial.
The aim of the following study is to evaluate che clinical efficacy of a toothpaste with biomimetic hydroxyapatite for the management of Molar-Incisor Hypomineralization. Patients who agree to participate to the study will use Biorepair toothpaste for the first 7 days of the month for 3, 6 and 9 months. The following indices will be measured: BEWE, Bleeding Index, Gingival index, Plaque index and the dental sensitivity test. The contralateral tooth will be used as control if not affected by MIH; otherwise, adjacent teeth will be considered.
Read the detailed description
Informed consent will be signed by the parents of the patients underage; patients will be asked the approval for the attendance of the study.
Adult patients will sign the informed consent for the treatment and for processing personal data for research purpose, with their approval for the attendance of the study.
Patients will be given for free a toothpaste with biomimetic hydroxyapatite (Biorepair Enamel-Repair Shock Treatment) and the Investigator will explain the correct procedures for home oral care. The toothpaste will be applied the first 7 days of the month for 9 months with a specific tray.
Teeth will be randomly assigned to:
- Trial group: 1 tooth with MIH from 1 quadrant will be treated with the biomimetic hydroxyapatite toothpaste. The applications will be performed for the first 7 days of the month for 9 months (1 application per day that lasts 10 minutes).
- Control group: 1 contralateral tooth with MIH will not be treated with the biomimetic hydroxyapatite toothpaste Patients will be visited after 1, 2, 3, 6 and 9 months from the baseline. For each visit, BEWE index, Bleeding Index, Gingival index, Plaque index and Dental sensitivity test. Tooth with MIH will be assessed, together with its contralaterals as control. If the contralateral tooth should suffer from MIH too, measurements will be carried out on the adjacent tooth.
- Conditions
- Molar Incisor Hypomineralization
- Being tested
- Biorepair Shock Treatment, No treatment
- Keywords
- biomimetic hydroxyapatite, enamel remineralization
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biorepair Shock TreatmentOther
Teeth from this group will undergo the application of Biorepair Toothpaste for the first 7 days of the month for 9 months (1 application per day that lasts 10 minutes).
No treatmentOther
Teeth from this group will not be treated with the experimental toothpaste.
| Study group | Role | What they receive |
|---|---|---|
| Trial Group | Experimental | Teeth from this group suffer from MIH. They will be evaluated after home oral care with BioRepair toothpaste containing microRepair®. Receives: Other: Biorepair Shock Treatment |
| Control Group | Active comparator | Teeth from this group suffer from MIH. They are in the contralateral quadrants in respect to teeth from trial group. They will not be treated with the hydroxyapatite toothpaste. Receives: Other: No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of BI - Bleeding Index
Scoring criteria:
- 0: absence of bleeding after 30 seconds
- 1: bleeding observed after 30 seconds
- 2: immediate bleeding
Measured: Study begin, 1,2,3, 6 and 9 months
Change of GI - Gingival Index (Loe and Silness, 1963)
Scoring criteria:
- 0 = normal gingiva.
- 1 = mild inflammation, edema and swelling; no bleeding.
- 2 = moderate inflammation with edema, swelling and bleeding on probing.
- 3 = severe inflammation with marked edema, redness tissues, ulceration and spontaneous bleeding.
Measured: Study begin, 1,2,3, 6 and 9 months
Change of PCR - Plaque Control Record (O'Leary, 1972)
4 surfaces scored (mesial, distal, vestibular, labial/palatal) per tooth by means of plaque relevator.
The Index is calculated multiplying the total number of surfaces with plaque per 100.
Measured: Study begin, 1,2,3, 6 and 9 months
Change in Schiff Air Index - Dental sensitivity test
Scoring criteria:
- the subject did not respond to air blasting;
- the subject responded to air blasting;
- the subject responded to air blasting and requested discontinuation;
- the subject responded to air blasting, requested discontinuation and considered the stimulus to be painful.
Measured: Study begin, 1,2,3, 6 and 9 months
Change of BEWE Index - Basic Erosive Wear Examination (Barlet et al., 2008)
Scoring criteria:
- 0: no erosive tooth wear;
- 1: initial loss of surface texture;
- 2: distinct defect, hard tissue loss < 50% of the surface area;
- 3: hard tissue loss ≥ 50% of the surface area.
Additionally, risk level for clinical management will be assessed.
Measured: Study begin, 1,2,3, 6 and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start25 Mar 2021
- Primary completion30 Jan 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molar Incisor HypomineralizationStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 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
- NCT04808180
- Sponsor's protocol ID
- 2021-MIH
- Status last verified
- Mar 2022
- First submitted
- 16 Mar 2021
- Last updated
- 4 Apr 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 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Biomimetic Hydroxyapatite in the Treatment of Molar Incisor Hypomineralization: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04808180
- Acronym / sponsor ID
- 2021-MIH
- Conditions
- Molar Incisor Hypomineralization
- Keywords
- biomimetic hydroxyapatite, enamel remineralization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 22 Mar 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 following study is to evaluate che clinical efficacy of a toothpaste with biomimetic hydroxyapatite for the management of Molar-Incisor Hypomineralization. Patients who agree to participate to the study will use Biorepair toothpaste for the first 7 days of the month for 3, 6 and 9 months. The following indices will be measured: BEWE, Bleeding Index, Gingival index, Plaque index and the dental sensitivity test. The contralateral tooth will be used as control if not affected by MIH; otherwise, adjacent teeth will be considered.
Detailed description
Informed consent will be signed by the parents of the patients underage; patients will be asked the approval for the attendance of the study.
Adult patients will sign the informed consent for the treatment and for processing personal data for research purpose, with their approval for the attendance of the study.
Patients will be given for free a toothpaste with biomimetic hydroxyapatite (Biorepair Enamel-Repair Shock Treatment) and the Investigator will explain the correct procedures for home oral care. The toothpaste will be applied the first 7 days of the month for 9 months with a specific tray.
Teeth will be randomly assigned to:
- Trial group: 1 tooth with MIH from 1 quadrant will be treated with the biomimetic hydroxyapatite toothpaste. The applications will be performed for the first 7 days of the month for 9 months (1 application per day that lasts 10 minutes).
- Control group: 1 contralateral tooth with MIH will not be treated with the biomimetic hydroxyapatite toothpaste Patients will be visited after 1, 2, 3, 6 and 9 months from the baseline. For each visit, BEWE index, Bleeding Index, Gingival index, Plaque index and Dental sensitivity test. Tooth with MIH will be assessed, together with its contralaterals as control. If the contralateral tooth should suffer from MIH too, measurements will be carried out on the adjacent tooth.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trial Group | Experimental | Other: Biorepair Shock TreatmentTeeth from this group suffer from MIH. They will be evaluated after home oral care with BioRepair toothpaste containing microRepair®. |
| Control Group | Active comparator | Other: No treatmentTeeth from this group suffer from MIH. They are in the contralateral quadrants in respect to teeth from trial group. They will not be treated with the hydroxyapatite toothpaste. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- presence of at least 2 enamel demineralizations of permanent molars and incisors (Molar-Incisor Hypomineralization - MIH) in contralateral quadrants
- good general health (absence of systemic diseases)
Key exclusion criteria (2 listed)
- patients undergoing orthodontic therapy
- patients taking drugs
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 |
|---|---|---|
| Biorepair Shock TreatmentTeeth from this group will undergo the application of Biorepair Toothpaste for the first 7 days of the month for 9 months (1 application per day that lasts 10 minutes). | Other | Trial Group |
| No treatmentTeeth from this group will not be treated with the experimental toothpaste. | Other | Control Group |
Primary outcome
Change of BI - Bleeding Index
Time frame: Study begin, 1,2,3, 6 and 9 months
Scoring criteria: * 0: absence of bleeding after 30 seconds * 1: bleeding observed after 30 seconds * 2: immediate bleeding
Change of GI - Gingival Index (Loe and Silness, 1963)
Time frame: Study begin, 1,2,3, 6 and 9 months
Scoring criteria: * 0 = normal gingiva. * 1 = mild inflammation, edema and swelling; no bleeding. * 2 = moderate inflammation with edema, swelling and bleeding on probing. * 3 = severe inflammation with marked edema, redness tissues, ulceration and spontaneous bleeding.
Change of PCR - Plaque Control Record (O'Leary, 1972)
Time frame: Study begin, 1,2,3, 6 and 9 months
4 surfaces scored (mesial, distal, vestibular, labial/palatal) per tooth by means of plaque relevator. The Index is calculated multiplying the total number of surfaces with plaque per 100.
Change in Schiff Air Index - Dental sensitivity test
Time frame: Study begin, 1,2,3, 6 and 9 months
Scoring criteria: 0. the subject did not respond to air blasting; 1. the subject responded to air blasting; 2. the subject responded to air blasting and requested discontinuation; 3. the subject responded to air blasting, requested discontinuation and considered the stimulus to be painful.
Change of BEWE Index - Basic Erosive Wear Examination (Barlet et al., 2008)
Time frame: Study begin, 1,2,3, 6 and 9 months
Scoring criteria: * 0: no erosive tooth wear; * 1: initial loss of surface texture; * 2: distinct defect, hard tissue loss < 50% of the surface area; * 3: hard tissue loss ≥ 50% of the surface area. Additionally, risk level for clinical management will be assessed.
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 4 Apr 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 Biorepair Shock Treatment and No treatment in people with Molar Incisor Hypomineralization, 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 2 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 4 Apr 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 of BI - Bleeding Index (time frame: Study begin, 1,2,3, 6 and 9 months). The study lists 5 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 4 Apr 2022.