Hypomineralization Molar IncisorNCT06538142
Photobiomodulation and New Restorative Material for Teeth With MIH on Control of Hypersensitivity and Longevity
A study testing Photobiomodulation + Restoration with Self-cure Composite Resin, Restoration with Self-cure Composite Resin and Photobiomodulation + Restoration with Photopolymerizable Bulk-fill Composite Resin in people with Hypomineralization Molar Incisor and Hypersensitivity Dentin, run by University of Nove de Julho.
Trial summary
Introduction: Molar incisor hypomineralization (MIH) is a qualitative defect of enamel development that occurs in the mineralization phase. MIH affects one or more permanent molars and, occasionally, permanent incisors. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypomineralization Molar Incisor, Hypersensitivity Dentin
- What is being tested?
- Photobiomodulation + Restoration with Self-cure Composite Resin, Restoration with Self-cure Composite Resin and Photobiomodulation + Restoration with Photopolymerizable Bulk-fill Composite Resin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 1 Sep 2026
- 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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male and female children;
- Eight to 12 years of age;
- At least one permanent first molar with MIH (codes 5 and 6 of molar-incisor hypomineralization severity scoring system [MIH-SSS])
- Presence of hypersensitivity
- Direct viewing and access.
Who cannot join
- Clinically: signs or symptoms of pulp involvement;
- Radiographically: evidence of pulp involvement (initial periapical radiograph);
- Teeth with MIH with no indication for direct restorative treatment (multiple surfaces associated with large extensions);
- Partially erupted teeth;
- Previous restorative treatment.
About this study
Official title: Assessment of Photobiomodulation Combined With New Restorative Material for Teeth With Molar Incisor Hypomineralization on Control of Hypersensitivity and Longevity of Restorations: Randomized Controlled Blind Clinical Trial
Introduction: Molar incisor hypomineralization (MIH) is a qualitative defect of enamel development that occurs in the mineralization phase. MIH affects one or more permanent molars and, occasionally, permanent incisors.
Objective: The aim of the proposed study is to determine whether photobiomodulation combined with a new self-cure resin improves hypersensitivity in molars with MIH and caries (primary outcome). Secondary outcomes include assessing the clinical performance of the self-cure composite resin in terms of restoration longevity and comparing the effectiveness of three interventions-photobiomodulation combined with self-cure resin, self-cure resin alone, and photobiomodulation combined with bulkfill photopolymerizable resin-in controlling hypersensitivity over time.
Methods and analysis: Permanent molars with MIH in patients eight to 12 years of age will be allocated to three groups. Group 1: photobiomodulation + self-cure composite resin restoration; Group 2: self-cure composite resin restoration; Group 3: photobiomodulation + restoration in bulk-fill photopolymerizable composite resin. Photobiomodulation will be performed in a single session involving low-level laser administered to four different points. The laser will be used at a wavelength of 808 nm, power of 100 mW and energy of 1 J per points; irradiance will be 3571 mW/cm², with a total radiant exposure of 35.7 J/cm². Data normality will be checked using the Shapiro-Wilk test, and variance homogeneity will be assessed with the Levene test. Descriptive statistics will be used to present the data, with continuous variables expressed as mean and standard deviation, and categorical variables by relative frequency. To compare the VAS and SCASS scales, repeated measures ANOVA will be employed, considering the 3 groups and 5 time points. Bonferroni adjustment will be applied for post-hoc comparisons. Sphericity will be tested with Mauchly's test, and if violated, Greenhouse-Geisser correction will be applied. A significance level of 0.05 will be adopted. Ethics and dissemination: This protocol received approval from the Human Research Ethics Committee of Nove de Julho University (certificate number: xxxxxxx). The legal guardians of the children will agree to participation by signing a statement of informed consent. The results will be published in a peer-review journal and the data will be made available upon request.
- Being tested
- Photobiomodulation + Restoration with Self-cure Composite Resin, Restoration with Self-cure Composite Resin, Photobiomodulation + Restoration with Photopolymerizable Bulk-fill Composite Resin
- Medical subject headings
- Molar Hypomineralization, Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation + Restoration with Self-cure Composite ResinProcedure or surgery
- Initial periapical radiograph;
- Hypersensitivity reading (visual analogue scale for subjective pain of volunteer and SCASS for examiner's assessment);
- Application of photobiomodulation;
- Relative isolation (lip bumper, cotton roll and aspirator);
- Selective removal of carious tissue with curette (only Code 6 of MIH-SSS criteria);
- Cleaning with cotton and water;
- Application of primer (Stela; SDI, Melbourne, Vic, Australia) on dentin and/or enamel, wait 5 seconds;
- Application of mild compressed air on adhesive for 3 seconds;
- Restoration with self-cure composite resin (Stela; SDI, Melbourne, Vic, Australia) extending to adjacent demarcated opacities;
- Clinical follow up after 48 hours and at four-month intervals for a period of 12 months;
- Hypersensitivity reading after 48 hours and at four-month intervals for a period of 12 months.
Restoration with Self-cure Composite ResinProcedure or surgery
- Initial periapical radiograph;
- Hypersensitivity reading (visual analogue scale for subjective pain of volunteer and SCASS for examiner's assessment);
- Relative isolation (lip bumper, cotton roll and aspirator);
- Selective removal of carious tissue with curette (only Code 6 of MIH-SSS criteria);
- Cleaning with cotton and water;
- Application of primer (Stela; SDI, Melbourne, Vic, Australia) on dentin and/or enamel, wait 5 seconds;
- Application of mild compressed air on adhesive for 3 seconds;
- Restoration with self-cure composite resin (Stela; SDI, Melbourne, Vic, Australia) extending to adjacent demarcated opacities;
- Clinical follow up after 48 hours and at four-month intervals for a period of 12 months;
- Hypersensitivity reading after 48 hours and at four-month intervals for a period of 12 months.
Photobiomodulation + Restoration with Photopolymerizable Bulk-fill Composite ResinProcedure or surgery
- Initial periapical radiograph;
- Hypersensitivity reading (visual analogue scale for subjective pain of volunteer and SCASS for examiner's assessment;
- Relative isolation;
- Application of photobiomodulation;
- Selective removal of carious tissue with curette (only Code 6 of MIH-SSS criteria);
- Selective etching of enamel adjacent to demarcated opacities with 35% phosphoric acid for 20s;
- Active application of universal adhesive (Ambar) on dentin and enamel for 20 seconds (repeat procedure);
- Application of mild compressed air on adhesive for 5 seconds;
- Photoactivation for 10s;
- Restoration with Tetric N Ceram bulk-fill composite resin; with increments up to 4 mm, extending to demarcated opacities;
- Photoactivation for 10 seconds;
- Clinical follow up after 48 hours and at four-month intervals for a period of 12 months;
- Hypersensitivity reading after 48 hours and at four-month intervals for a period of 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation + Restoration with self-cure composite resin | Experimental | The participants will receive photobiomodulation + self-cure composite resin restoration. Receives: Procedure: Photobiomodulation + Restoration with Self-cure Composite Resin |
| Restoration with Self-cure Composite Resin | Experimental | The participants will receive self-cure composite resin restoration. Receives: Procedure: Restoration with Self-cure Composite Resin |
| Photobiomodulation + Restoration with Photopolymerizable Bulk-fill Composite Resin | Experimental | The participants will receive photobiomodulation + restoration in bulk-fill photopolymerizable composite resin restoration. Receives: Procedure: Photobiomodulation + Restoration with Photopolymerizable Bulk-fill Composite Resin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypersensitivity Assessment
The Visual Analogue Scale (VAS) will be used for the subjective assessment of hypersensitivity on the part of the volunteer and the Schiff Cold Air Sensitivity Scale (SCASS) will be used for the assessment of the operator and examiner. Following isolation of the neighboring teeth with gauze, compressed air will be applied to the tooth with MIH for three seconds. The SCASS is scored as follows: 0 (no reaction); 1 (no reaction, but patient reports discomfort); 2 (patient reacts and moves away from stimulus); and 3 (patient reacts and asks operator to stop).
Measured: Prior to the procedure, 48 hours after restorative treatment and at four-month intervals for the 12-month follow-up period.
Secondary outcomes (1)
Clinical Assessment
The criteria will be the retention of the restorative material in the cavity, rupture of the enamel adjacent to the restoration and the occurrence of secondary caries. The criteria of the modified USPHS index will be used for the assessment. The restoration will be characterized as a failure and the tooth will be excluded from the study if the C score is determined for any of the USPHS criteria. Photographs of the restorations will be taken using a digital single-lens reflex (DSLR) camera (Canon EOS 700D; Canon, Tokyo, Honshu, Japan) to complement the clinical data. The visual demonstration will contribute to any necessary clarifications and make the discussion and documentation of the cases more efficient.
Measured: Clinical follow up after 48 hours and at four-month intervals for a period of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start1 Apr 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypomineralization Molar IncisorStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Kalil Bussadori, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538142
- Sponsor's protocol ID
- NewRestorativeMaterial
- Status last verified
- Jan 2025
- First submitted
- 31 Jul 2024
- Last updated
- 22 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ribeiro CDPV, Mandetta ARH, Pernomiam FC, Camargo CCB, Romano IMF, Sobral APT, Leal ML, Mesquita-Ferrari RA, Fernandes KPS, Horliana ACRT, Motta LJ, Duran CCG, Bussadori SK. Assessment of photobiomodulation combined with new restorative material for teeth with molar incisor hypomineralization on control of hypersensitivity and longevity of restorations: Protocol for a randomized controlled blind clinical trial. PLoS One. 2025 Aug 13;20(8):e0329641. doi: 10.1371/journal.pone.0329641. eCollection 2025.
PubMed 40802785
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Photobiomodulation Combined With New Restorative Material for Teeth With Molar Incisor Hypomineralization on Control of Hypersensitivity and Longevity of Restorations: Randomized Controlled Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT06538142
- Acronym / sponsor ID
- NewRestorativeMaterial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 5 Aug 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.
Introduction: Molar incisor hypomineralization (MIH) is a qualitative defect of enamel development that occurs in the mineralization phase. MIH affects one or more permanent molars and, occasionally, permanent incisors.
Objective: The aim of the proposed study is to determine whether photobiomodulation combined with a new self-cure resin improves hypersensitivity in molars with MIH and caries (primary outcome). Secondary outcomes include assessing the clinical performance of the self-cure composite resin in terms of restoration longevity and comparing the effectiveness of three interventions-photobiomodulation combined with self-cure resin, self-cure resin alone, and photobiomodulation combined with bulkfill photopolymerizable resin-in controlling hypersensitivity over time.
Methods and analysis: Permanent molars with MIH in patients eight to 12 years of age will be allocated to three groups. Group 1: photobiomodulation + self-cure composite resin restoration; Group 2: self-cure composite resin restoration; Group 3: photobiomodulation + restoration in bulk-fill photopolymerizable composite resin. Photobiomodulation will be performed in a single session involving low-level laser administered to four different points. The laser will be used at a wavelength of 808 nm, power of 100 mW and energy of 1 J per points; irradiance will be 3571 mW/cm², with a total radiant exposure of 35.7 J/cm². Data normality will be checked using the Shapiro-Wilk test, and variance homogeneity will be assessed with the Levene test. Descriptive statistics will be used to present the data, with continuous variables expressed as mean and standard deviation, and categorical variables by relative frequency. To compare the VAS and SCASS scales, repeated measures ANOVA will be employed, considering the 3 groups and 5 time points. Bonferroni adjustment will be applied for post-hoc comparisons. Sphericity will be tested with Mauchly's test, and if violated, Greenhouse-Geisser correction will be applied. A significance level of 0.05 will be adopted. Ethics and dissemination: This protocol received approval from the Human Research Ethics Committee of Nove de Julho University (certificate number: xxxxxxx). The legal guardians of the children will agree to participation by signing a statement of informed consent. The results will be published in a peer-review journal and the data will be made available upon request.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation + Restoration with self-cure composite resin | Experimental | Procedure: Photobiomodulation + Restoration with Self-cure Composite ResinThe participants will receive photobiomodulation + self-cure composite resin restoration. |
| Restoration with Self-cure Composite Resin | Experimental | Procedure: Restoration with Self-cure Composite ResinThe participants will receive self-cure composite resin restoration. |
| Photobiomodulation + Restoration with Photopolymerizable Bulk-fill Composite Resin | Experimental | Procedure: Photobiomodulation + Restoration with Photopolymerizable Bulk-fill Composite ResinThe participants will receive photobiomodulation + restoration in bulk-fill photopolymerizable composite resin restoration. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Male and female children;
- Eight to 12 years of age;
- At least one permanent first molar with MIH (codes 5 and 6 of molar-incisor hypomineralization severity scoring system [MIH-SSS])
- Presence of hypersensitivity
- Direct viewing and access.
Key exclusion criteria (5 listed)
- Clinically: signs or symptoms of pulp involvement;
- Radiographically: evidence of pulp involvement (initial periapical radiograph);
- Teeth with MIH with no indication for direct restorative treatment (multiple surfaces associated with large extensions);
- Partially erupted teeth;
- Previous restorative treatment.
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 |
|---|---|---|
| Photobiomodulation + Restoration with Self-cure Composite Resin1. Initial periapical radiograph; 2. Hypersensitivity reading (visual analogue scale for subjective pain of volunteer and SCASS for examiner's assessment); 3. Application of photobiomodulation; 4. Relative isolation (lip bumper, cotton roll and aspirator); 5. Selective removal of carious tissue with curette (only Code 6 of MIH-SSS criteria); 6. Cleaning with cotton and water; 7. Application of primer (Stela; SDI, Melbourne, Vic, Australia) on dentin and/or enamel, wait 5 seconds; 8. Application of mild compressed air on adhesive for 3 seconds; 9. Restoration with self-cure composite resin (Stela; SDI, Melbourne, Vic, Australia) extending to adjacent demarcated opacities; 10. Clinical follow up after 48 hours and at four-month intervals for a period of 12 months; 11. Hypersensitivity reading after 48 hours and at four-month intervals for a period of 12 months. | Procedure or surgery | Photobiomodulation + Restoration with self-cure composite resin |
| Restoration with Self-cure Composite Resin1. Initial periapical radiograph; 2. Hypersensitivity reading (visual analogue scale for subjective pain of volunteer and SCASS for examiner's assessment); 3. Relative isolation (lip bumper, cotton roll and aspirator); 4. Selective removal of carious tissue with curette (only Code 6 of MIH-SSS criteria); 5. Cleaning with cotton and water; 6. Application of primer (Stela; SDI, Melbourne, Vic, Australia) on dentin and/or enamel, wait 5 seconds; 7. Application of mild compressed air on adhesive for 3 seconds; 8. Restoration with self-cure composite resin (Stela; SDI, Melbourne, Vic, Australia) extending to adjacent demarcated opacities; 9. Clinical follow up after 48 hours and at four-month intervals for a period of 12 months; 10. Hypersensitivity reading after 48 hours and at four-month intervals for a period of 12 months. | Procedure or surgery | Restoration with Self-cure Composite Resin |
| Photobiomodulation + Restoration with Photopolymerizable Bulk-fill Composite Resin1. Initial periapical radiograph; 2. Hypersensitivity reading (visual analogue scale for subjective pain of volunteer and SCASS for examiner's assessment; 3. Relative isolation; 4. Application of photobiomodulation; 5. Selective removal of carious tissue with curette (only Code 6 of MIH-SSS criteria); 6. Selective etching of enamel adjacent to demarcated opacities with 35% phosphoric acid for 20s; 7. Active application of universal adhesive (Ambar) on dentin and enamel for 20 seconds (repeat procedure); 8. Application of mild compressed air on adhesive for 5 seconds; 9. Photoactivation for 10s; 10. Restoration with Tetric N Ceram bulk-fill composite resin; with increments up to 4 mm, extending to demarcated opacities; 11. Photoactivation for 10 seconds; 12. Clinical follow up after 48 hours and at four-month intervals for a period of 12 months; 13. Hypersensitivity reading after 48 hours and at four-month intervals for a period of 12 months. | Procedure or surgery | Photobiomodulation + Restoration with Photopolymerizable Bulk-fill Composite Resin |
Primary outcome
Hypersensitivity Assessment
Time frame: Prior to the procedure, 48 hours after restorative treatment and at four-month intervals for the 12-month follow-up period.
The Visual Analogue Scale (VAS) will be used for the subjective assessment of hypersensitivity on the part of the volunteer and the Schiff Cold Air Sensitivity Scale (SCASS) will be used for the assessment of the operator and examiner. Following isolation of the neighboring teeth with gauze, compressed air will be applied to the tooth with MIH for three seconds. The SCASS is scored as follows: 0 (no reaction); 1 (no reaction, but patient reports discomfort); 2 (patient reacts and moves away from stimulus); and 3 (patient reacts and asks operator to stop).
1 secondary outcome
Clinical Assessment
Time frame: Clinical follow up after 48 hours and at four-month intervals for a period of 12 months
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 22 Jan 2025.
- Derived from this study: PubMed 40802785Ribeiro CDPV, Mandetta ARH, Pernomiam FC, Camargo CCB, Romano IMF, Sobral APT, Leal ML, Mesquita-Ferrari RA, Fernandes KPS, Horliana ACRT, Motta LJ, Duran CCG, Bussadori SK. Assessment of photobiomodulation combined with new restorative material for teeth with molar incisor hypomineralization on control of hypersensitivity and longevity of restorations: Protocol for a randomized controlled blind clinical trial. PLoS One. 2025 Aug 13;20(8):e0329641. doi: 10.1371/journal.pone.0329641. eCollection 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation + Restoration with Self-cure Composite Resin, Restoration with Self-cure Composite Resin and Photobiomodulation + Restoration with Photopolymerizable Bulk-fill Composite Resin in people with Hypomineralization Molar Incisor and Hypersensitivity Dentin, run by University of Nove de Julho.
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 5 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: opening soon, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Hypersensitivity Assessment (time frame: Prior to the procedure, 48 hours after restorative treatment and at four-month intervals for the 12-month follow-up period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06538142, which also lists 1 linked publication.
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 22 Jan 2025.