Molar Incisor HypomineralizationNCT06396988
Clinical Efficacy of Calcium and Sodium Phosphosilicate (Novamin) in the Treatment of MIH (Molar Incisor Hypolimineralization) in Pediatric Patients
A study testing Novamin application and Parodontax application 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 the clinical efficacy of a toothpaste with calcium and sodium phosphosilicate in the treatment of demineralization of the dental enamel of molars and incisors in pediatric patients. Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Molar Incisor Hypomineralization
- What is being tested?
- Novamin application and Parodontax application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 15 May 2024to 15 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Presence of at least 2 demineralizations of the dental enamel of molars and incisors (molar incisor hypomineralization-MIH) on contralateral permanent teeth
- Patients with mild or moderate MIH
- Good general health (absence of particular systemic pathologies)
Who cannot join
- Patients undergoing orthodontic therapy
- Patients taking drugs
- Patients with severe MIH (tooth surface with defect \> 2/3, post-eruptive enamel breakage)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
Pavia, Lombardy, 27100
About this study
Official title: Clinical Efficacy of Calcium and Sodium Phosphosilicate (Novamin) in the Treatment of MIH (Molar Incisor Hypolimineralization) in Pediatric Patients: Randomized Clinical Trial
The aim of the following study is to evaluate the clinical efficacy of a toothpaste with calcium and sodium phosphosilicate in the treatment of demineralization of the dental enamel of molars and incisors in pediatric patients. Patients who agree to participate to the study will use 2 different toothpaste Sensodyne Repair and Protect and Parodontax, which will used with split mouth design. The following indices will be measured: BEWE, Bleeding Index, Gingival Index, Plaque Index, Dental sensitivity test- Schiff, Pain Intensity Index- VAS and PPD.
Read the detailed description
Informed consent will be signed by the parents of the patients underage and will be asked the approval for the attendance of the study. To the parents of pediatric patients will be given for free the 2 toothpastes and will be explain the correct procedures for home oral care. The method used in the study is "Split-Mouth" design, in which contralateral teeth with MIH will used for control group. For the study the patients must have at least two demineralizations present on contralateral permanent molars or incisors. The toothpaste used for the study consist in 2 different types: Sensodyne Repair\&Protect (used for the Trial group) and Parodontax Complete Protection (used for the control group).
The 2 toothpastes will be applied once a day, before going to sleep after normal oral hygiene, for at least two minutes for 28 days after each meeting. The products must be used in minimal quantities, in pea-size doses, applying it on the tooth with the finger while performing a massage, under the supervision of the parents and then rinsing.
At each meeting will be taken all the indices and the timing is: T0- study begin, T1- after 1 month, T2-after 3 months, T3- after 6 months, T4- after 9 months, T5- after 12 months.
- Conditions
- Molar Incisor Hypomineralization
- Being tested
- Novamin application, Parodontax application
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novamin applicationOther
Teeth from this group will be treated with the application of Sensodyne Repair\&Protect Toothpaste for 28 days after each visit (1 application per day for 2 minutes).
Parodontax applicationOther
Teeth from this group will be treated with the application of Parodontax Complete Protection Toothpaste for 28 days after each visit (1 application per day for 2 minutes).
| Study group | Role | What they receive |
|---|---|---|
| Novamin | Experimental | Not described Receives: Other: Novamin application |
| Parodontax | Active comparator | Not described Receives: Other: Parodontax application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bleeding Index
0: absence of bleeding after 30 seconds
- bleeding observed after 30 seconds
- immediate bleeding
Measured: Study begin, 1, 3, 6, 9, 12 months
Change in Gingival Index
0: normal gingiva
- mild inflammation, edema and swelling, no bleeding
- moderate inflammation with edema, sweelling and bleeding on probing
- severe inflammation with marked edema, redness tissues, ulceration and spontaneous bleeding
Measured: Study begin, 1, 3, 6, 9, 12 months
Change in Plaque Control Record
The index is calculated multiplying the total number of surfaces with plaque per 100
Measured: Study begin, 1, 3, 6, 9, 12 months
Change in Schiff Air Index
0: 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, 3, 6, 9, 12 months
Change in Basic Erosive Wear Examination
0: no erosive tooth wear
- initial loss of surface texture
- distinct defect, hard tissue loss \< 50% of the surface area
- hard tissue loss ≥ 50% of the surface area
Measured: Study begin, 1, 3, 6, 9, 12 months
Change in Wong- Backer faces pain rating scales
0-1: no pain 1-2: milde pain 3-4: moderate pain 5-6: acute pain 7-8: very severe pain 9-10: unbearable pain
Measured: Study begin, 1, 3, 6, 9, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start15 May 2024
- Primary completion10 Jan 2027 (estimated)
- Study completion15 Jan 2027 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Split-mouth study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
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
- NCT06396988
- Sponsor's protocol ID
- 2024-MIHNOVAMIN
- Status last verified
- Jun 2024
- First submitted
- 29 Apr 2024
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon motivated request to the PI.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Calcium and Sodium Phosphosilicate (Novamin) in the Treatment of MIH (Molar Incisor Hypolimineralization) in Pediatric Patients: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06396988
- Acronym / sponsor ID
- 2024-MIHNOVAMIN
- Conditions
- Molar Incisor Hypomineralization
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 10 Jan 2027 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 2 May 2024 (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 the clinical efficacy of a toothpaste with calcium and sodium phosphosilicate in the treatment of demineralization of the dental enamel of molars and incisors in pediatric patients. Patients who agree to participate to the study will use 2 different toothpaste Sensodyne Repair and Protect and Parodontax, which will used with split mouth design. The following indices will be measured: BEWE, Bleeding Index, Gingival Index, Plaque Index, Dental sensitivity test- Schiff, Pain Intensity Index- VAS and PPD.
Detailed description
Informed consent will be signed by the parents of the patients underage and will be asked the approval for the attendance of the study. To the parents of pediatric patients will be given for free the 2 toothpastes and will be explain the correct procedures for home oral care. The method used in the study is "Split-Mouth" design, in which contralateral teeth with MIH will used for control group. For the study the patients must have at least two demineralizations present on contralateral permanent molars or incisors. The toothpaste used for the study consist in 2 different types: Sensodyne Repair\&Protect (used for the Trial group) and Parodontax Complete Protection (used for the control group).
The 2 toothpastes will be applied once a day, before going to sleep after normal oral hygiene, for at least two minutes for 28 days after each meeting. The products must be used in minimal quantities, in pea-size doses, applying it on the tooth with the finger while performing a massage, under the supervision of the parents and then rinsing.
At each meeting will be taken all the indices and the timing is: T0- study begin, T1- after 1 month, T2-after 3 months, T3- after 6 months, T4- after 9 months, T5- after 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Split-mouth study
| Arm | Type | Receives |
|---|---|---|
| Novamin | Experimental | Other: Novamin application |
| Parodontax | Active comparator | Other: Parodontax application |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Presence of at least 2 demineralizations of the dental enamel of molars and incisors (molar incisor hypomineralization-MIH) on contralateral permanent teeth
- Patients with mild or moderate MIH
- Good general health (absence of particular systemic pathologies)
Key exclusion criteria (3 listed)
- Patients undergoing orthodontic therapy
- Patients taking drugs
- Patients with severe MIH (tooth surface with defect \> 2/3, post-eruptive enamel breakage)
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 |
|---|---|---|
| Novamin applicationTeeth from this group will be treated with the application of Sensodyne Repair\&Protect Toothpaste for 28 days after each visit (1 application per day for 2 minutes). | Other | Novamin |
| Parodontax applicationTeeth from this group will be treated with the application of Parodontax Complete Protection Toothpaste for 28 days after each visit (1 application per day for 2 minutes). | Other | Parodontax |
Primary outcome
Change in Bleeding Index
Time frame: Study begin, 1, 3, 6, 9, 12 months
0: absence of bleeding after 30 seconds 1. bleeding observed after 30 seconds 2. immediate bleeding
Change in Gingival Index
Time frame: Study begin, 1, 3, 6, 9, 12 months
0: normal gingiva 1. mild inflammation, edema and swelling, no bleeding 2. moderate inflammation with edema, sweelling and bleeding on probing 3. severe inflammation with marked edema, redness tissues, ulceration and spontaneous bleeding
Change in Plaque Control Record
Time frame: Study begin, 1, 3, 6, 9, 12 months
The index is calculated multiplying the total number of surfaces with plaque per 100
Change in Schiff Air Index
Time frame: Study begin, 1, 3, 6, 9, 12 months
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 in Basic Erosive Wear Examination
Time frame: Study begin, 1, 3, 6, 9, 12 months
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
Change in Wong- Backer faces pain rating scales
Time frame: Study begin, 1, 3, 6, 9, 12 months
0-1: no pain 1-2: milde pain 3-4: moderate pain 5-6: acute pain 7-8: very severe pain 9-10: unbearable pain
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Individual participant dataSharing planned: No. Data will be available upon motivated request to the PI.
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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.
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 Novamin application and Parodontax application 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 3 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 18 Jun 2024. 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?
This study is still under way. Results are not available in the source record yet.
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 Bleeding Index (time frame: Study begin, 1, 3, 6, 9, 12 months). The study lists 6 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 18 Jun 2024.