Hypomineralization Molar IncisorPhase 1/2NCT05370417
Photobiomodulation and Glass Ionomer Sealant as Complementary Treatment for Hypersensitivity in Molars With MIH
A Phase 1/2 study testing Use of fluoride toothpaste, Photobiomodulation and Simulated Laser Therapy in people with Hypomineralization Molar Incisor, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
Introduction: Photobiomodulation (PBM) shows promising results for the complementary treatment of dentin hypersensitivity; however, few studies have evaluated this treatment specifically for teeth affected by molar incisor hypomineralization (MIH). Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypomineralization Molar Incisor
- What is being tested?
- Use of fluoride toothpaste, Photobiomodulation and Simulated Laser Therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 19 Jul 2022to 12 Mar 2024
- Phase
- Phase 1/2
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy individuals (ASA I);
- Children aged 6 to 12 years with at least one permanent first molar affected by MIH grades 3 and 4 (a and b) according to the MIH Treatment Needs Index (TNI), and with hypersensitivity score 2 or higher on the visual analog scale (VAS);
- Molars with fractures and without pulp involvement or active caries;
- Molars with eruption of the entire occlusal surface and at least one-third of the vestibular surface.
Who cannot join
- Molars with hypersensitivity caused by carious lesions were excluded to avoid diagnostic confusion with pulpitis;
- Teeth that had undergone desensitizing treatments in the previous three months, except for daily use toothpaste;
- Those with fixed orthodontic appliances; Patients who experienced discomfort during the hypersensitivity test, or those unable to tolerate the procedure were also excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Photobiomodulation and Glass Ionomer Sealant as Complementary Treatment for Hypersensitivity in Molars With MIH in Children - Protocol for a Blinded Randomized Clinical Trial.
Introduction: Photobiomodulation (PBM) shows promising results for the complementary treatment of dentin hypersensitivity; however, few studies have evaluated this treatment specifically for teeth affected by molar incisor hypomineralization (MIH). The aim of this study was to assess the effects of photobiomodulation combined with glass ionomer sealant on hypersensitivity in molars with MIH. Methods: Forty-nine children six to twelve years of age with a molar affected by MIH (Grade 3, 4a or 4b) of the MIH-TNI (Treatment Needs Index) criteria were randomly allocated to two groups - Group 1 (control group) (n = 25): toothpaste with fluoride concentration ≥ 1000 ppm (Parts Per Million) twice per day, glass ionomer sealant and simulated PBM; Group 2 (study group) (n = 24): toothpaste with fluoride concentration ≥ 1000 ppm twice per day, glass ionomer sealant and active PBM. Data collection involved the record of MIH, Schiff cold air sensitivity scale (SCASS), visual analog scale (VAS), the simplified oral hygiene index (OHI) and the colour, coverage, caries (CCC) sealant evaluation system. Results: Forty-six children completed the study and were evaluated one month after the onset of treatment. A significant reduction in the Schiff Cold Air Sensitivity Scale (SCASS) was found only in the active PBM group. Reductions in Visual Analog Scale (VAS) scores were observed in both groups, with a statistically significant difference between the groups at the 48-hour and 1-month assessments following PBM application. Similarly, significant differences in the Oral Hygiene Index (OHI) were found only in the active PBM group when comparing baseline values to those after 48 hours and one month. A significant difference between the groups was noted for sealant durability at one month, with better scores in the active PBM group. Conclusion: The administration of photobiomodulation combined with glass ionomer cement improves hypersensitivity and oral hygiene in molars with MIH. The improvement in oral hygiene increases the quantity of remaining sealant on teeth with MIH.
- Conditions
- Hypomineralization Molar Incisor
- Being tested
- Use of fluoride toothpaste, Photobiomodulation, Simulated Laser Therapy, Sealant 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.
Use of fluoride toothpasteOther
The participants received oral hygiene instructions - routine brushing twice per day with toothpaste containing 1000 ppm of fluoride. All participants received a toothbrush and toothpaste to ensure standardization. The aim of this intervention was to assess whether the participants' brushing technique would improve with desensitization.
PhotobiomodulationRadiation
For laser application, the following dosimetric parameters will be used:
Low level laser diode (infra red) wavelength 808nm with a power of 100mW. Three sessions: initial session, after 48 hours and after one month. LLL was applied to three perpendicular points in contact with the surface on the mesial vestibular and distal cervical faces and in the center of the occlusal face. An energy of 1 J was applied for 10 seconds at each point.
Simulated Laser TherapyProcedure or surgery
The same application described in the laser therapy group will be simulated, with the device turned off.
Sealant applicationProcedure or surgery
A glass ionomer sealant will be applied to the occlusal surface of the first permanent molar.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Sham comparator | Participants in this group received toothpaste with fluoride concentration ≥ 1000 ppm (Parts Per Million), glass ionomer sealant and simulated low-level laser. Receives: Other: Use of fluoride toothpaste; Procedure: Simulated Laser Therapy; Procedure: Sealant application |
| Study Group | Active comparator | Participants in this group received toothpaste with fluoride concentration ≥ 1000 ppm (Parts Per Million), glass ionomer sealant and active low-level laser. Receives: Other: Use of fluoride toothpaste; Radiation: Photobiomodulation; Procedure: Sealant application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pain - Visual analog scale (VAS)
The perception of pain in children was assessed using the Wong-Baker Faces Pain Rating Scale. This scale facilitates communication, allowing for a more accurate assessment of the pain reported by the child.
Measured: Baseline, 48 hours after the procedures and 1 month after.
Changes in the Schiff Cold Air Sensitivity Scale (SCASS)
The (SCASS) will be used to assess subject response to this stimulus (0=no response to the stimulus; 1=no response to the stimulus, patient considers stimulus to be painful; 2= response to stimulus, patient moves from the stimulus; 3= response to the stimulus, patient moves from the stimulus and requests immediate discontinuation of the stimulus).
Measured: Baseline, 48 hours after the procedures and 1 month after.
Secondary outcomes (2)
Changes in the Simplified Oral Hygiene Index (Greene and Vermillion)
Analysis of soft plaque deposit:
Code 0 = no deposits or pigmentation Code 1 = deposits covering less than 1/3 or presence of pigmentation Code 2 = deposits covering more than 1/3 but less than 2/3 Code 3 = deposits covering more than 2/3 of tooth surface
Measured: Baseline, 48 hours after the procedures and 1 month after.
Sealant Assessment System
The retention of the sealant was evaluated after 1 month using the CCC Sealant Evaluation System. For statistical purposes, the following classification was considered: A: sealant present; B: Sealant present on 50% of fissure pattern but some missing; C: Sealant present on 50% of fissure pattern.; D: no sealant present.
Measured: Baseline, 48 hours after the procedures and 1 month after.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start19 Jul 2022
- Primary completion20 Mar 2023
- Study completion12 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
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
- NCT05370417
- Sponsor's protocol ID
- PBMDHMI
- Status last verified
- Oct 2024
- First submitted
- 6 May 2022
- Last updated
- 3 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fossati AL, Mandetta ARH, Sobral APT, Bruno LH, Viarengo NO, Sertaje MRF, Santos EM, Goncalves MLL, Mesquita-Ferrari RA, Fernandes KPS, Horliana ACRT, Motta LJ, Deana AM, Dos Santos-Pinto LAM, Bussadori SK. Randomized clinical trial of photobiomodulation and glass ionomer sealant for hypersensitivity in molar incisor hypomineralization. Sci Rep. 2025 Aug 29;15(1):31911. doi: 10.1038/s41598-025-17454-8.
PubMed 40883469Fossati AL, Sobral APT, Hermida Bruno MLL, Viarengo NO, Sertaje MRF, Santos EM, Goncalves MLL, Ferrari RAM, Fernandes KPS, Horliana ACRT, Motta LJ, Bussadori SK. Photobiomodulation and glass ionomer sealant as complementary treatment for hypersensitivity in molar incisor hypomineralisation in children: protocol for a blinded randomised clinical trial. BMJ Open. 2023 Jun 14;13(6):e068102. doi: 10.1136/bmjopen-2022-068102.
PubMed 37316315
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photobiomodulation and Glass Ionomer Sealant as Complementary Treatment for Hypersensitivity in Molars With MIH in Children - Protocol for a Blinded Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05370417
- Acronym / sponsor ID
- PBMDHMI
- Conditions
- Hypomineralization Molar Incisor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 19 Jul 2022 (actual)
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 12 Mar 2024 (actual)
- First posted
- 11 May 2022 (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: Photobiomodulation (PBM) shows promising results for the complementary treatment of dentin hypersensitivity; however, few studies have evaluated this treatment specifically for teeth affected by molar incisor hypomineralization (MIH). The aim of this study was to assess the effects of photobiomodulation combined with glass ionomer sealant on hypersensitivity in molars with MIH. Methods: Forty-nine children six to twelve years of age with a molar affected by MIH (Grade 3, 4a or 4b) of the MIH-TNI (Treatment Needs Index) criteria were randomly allocated to two groups - Group 1 (control group) (n = 25): toothpaste with fluoride concentration ≥ 1000 ppm (Parts Per Million) twice per day, glass ionomer sealant and simulated PBM; Group 2 (study group) (n = 24): toothpaste with fluoride concentration ≥ 1000 ppm twice per day, glass ionomer sealant and active PBM. Data collection involved the record of MIH, Schiff cold air sensitivity scale (SCASS), visual analog scale (VAS), the simplified oral hygiene index (OHI) and the colour, coverage, caries (CCC) sealant evaluation system. Results: Forty-six children completed the study and were evaluated one month after the onset of treatment. A significant reduction in the Schiff Cold Air Sensitivity Scale (SCASS) was found only in the active PBM group. Reductions in Visual Analog Scale (VAS) scores were observed in both groups, with a statistically significant difference between the groups at the 48-hour and 1-month assessments following PBM application. Similarly, significant differences in the Oral Hygiene Index (OHI) were found only in the active PBM group when comparing baseline values to those after 48 hours and one month. A significant difference between the groups was noted for sealant durability at one month, with better scores in the active PBM group. Conclusion: The administration of photobiomodulation combined with glass ionomer cement improves hypersensitivity and oral hygiene in molars with MIH. The improvement in oral hygiene increases the quantity of remaining sealant on teeth with MIH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Sham comparator | Other: Use of fluoride toothpaste, Procedure: Simulated Laser Therapy, Procedure: Sealant applicationParticipants in this group received toothpaste with fluoride concentration ≥ 1000 ppm (Parts Per Million), glass ionomer sealant and simulated low-level laser. |
| Study Group | Active comparator | Other: Use of fluoride toothpaste, Radiation: Photobiomodulation, Procedure: Sealant applicationParticipants in this group received toothpaste with fluoride concentration ≥ 1000 ppm (Parts Per Million), glass ionomer sealant and active low-level laser. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy individuals (ASA I);
- Children aged 6 to 12 years with at least one permanent first molar affected by MIH grades 3 and 4 (a and b) according to the MIH Treatment Needs Index (TNI), and with hypersensitivity score 2 or higher on the visual analog scale (VAS);
- Molars with fractures and without pulp involvement or active caries;
- Molars with eruption of the entire occlusal surface and at least one-third of the vestibular surface.
Key exclusion criteria (3 listed)
- Molars with hypersensitivity caused by carious lesions were excluded to avoid diagnostic confusion with pulpitis;
- Teeth that had undergone desensitizing treatments in the previous three months, except for daily use toothpaste;
- Those with fixed orthodontic appliances; Patients who experienced discomfort during the hypersensitivity test, or those unable to tolerate the procedure were also excluded.
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 |
|---|---|---|
| Use of fluoride toothpasteThe participants received oral hygiene instructions - routine brushing twice per day with toothpaste containing 1000 ppm of fluoride. All participants received a toothbrush and toothpaste to ensure standardization. The aim of this intervention was to assess whether the participants' brushing technique would improve with desensitization. | Other | Control Group, Study Group |
| PhotobiomodulationFor laser application, the following dosimetric parameters will be used: Low level laser diode (infra red) wavelength 808nm with a power of 100mW. Three sessions: initial session, after 48 hours and after one month. LLL was applied to three perpendicular points in contact with the surface on the mesial vestibular and distal cervical faces and in the center of the occlusal face. An energy of 1 J was applied for 10 seconds at each point. | Radiation | Study Group |
| Simulated Laser TherapyThe same application described in the laser therapy group will be simulated, with the device turned off. | Procedure or surgery | Control Group |
| Sealant applicationA glass ionomer sealant will be applied to the occlusal surface of the first permanent molar. | Procedure or surgery | Control Group, Study Group |
Primary outcome
Changes in pain - Visual analog scale (VAS)
Time frame: Baseline, 48 hours after the procedures and 1 month after.
The perception of pain in children was assessed using the Wong-Baker Faces Pain Rating Scale. This scale facilitates communication, allowing for a more accurate assessment of the pain reported by the child.
Changes in the Schiff Cold Air Sensitivity Scale (SCASS)
Time frame: Baseline, 48 hours after the procedures and 1 month after.
The (SCASS) will be used to assess subject response to this stimulus (0=no response to the stimulus; 1=no response to the stimulus, patient considers stimulus to be painful; 2= response to stimulus, patient moves from the stimulus; 3= response to the stimulus, patient moves from the stimulus and requests immediate discontinuation of the stimulus).
2 secondary outcomes
Changes in the Simplified Oral Hygiene Index (Greene and Vermillion)
Time frame: Baseline, 48 hours after the procedures and 1 month after.
Sealant Assessment System
Time frame: Baseline, 48 hours after the procedures and 1 month after.
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 3 Oct 2024.
- Derived from this study: PubMed 40883469Fossati AL, Mandetta ARH, Sobral APT, Bruno LH, Viarengo NO, Sertaje MRF, Santos EM, Goncalves MLL, Mesquita-Ferrari RA, Fernandes KPS, Horliana ACRT, Motta LJ, Deana AM, Dos Santos-Pinto LAM, Bussadori SK. Randomized clinical trial of photobiomodulation and glass ionomer sealant for hypersensitivity in molar incisor hypomineralization. Sci Rep. 2025 Aug 29;15(1):31911. doi: 10.1038/s41598-025-17454-8.
- Derived from this study: PubMed 37316315Fossati AL, Sobral APT, Hermida Bruno MLL, Viarengo NO, Sertaje MRF, Santos EM, Goncalves MLL, Ferrari RAM, Fernandes KPS, Horliana ACRT, Motta LJ, Bussadori SK. Photobiomodulation and glass ionomer sealant as complementary treatment for hypersensitivity in molar incisor hypomineralisation in children: protocol for a blinded randomised clinical trial. BMJ Open. 2023 Jun 14;13(6):e068102. doi: 10.1136/bmjopen-2022-068102.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Use of fluoride toothpaste, Photobiomodulation and Simulated Laser Therapy in people with Hypomineralization Molar Incisor, run by University of Nove de Julho at 1 site in Brazil.
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 4 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: finished, as of the sponsor's last update on 3 Oct 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 Brazil. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Changes in pain - Visual analog scale (VAS) (time frame: Baseline, 48 hours after the procedures and 1 month after.). The study lists 2 primary outcomes in all. 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 NCT05370417, which also lists 2 linked publications.
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 3 Oct 2024.