Molar Incisor HypomineralizationNCT06154733
HYPERSENSITIVITY IN MOLAR INCISOR HYPOMINERALISATION USING LOW LEVEL LASER IN CHILDREN
A study testing Photobiomodulation usinf low level laser therapy, Resin-based sealant and Glass ionomer sealant in people with Molar Incisor Hypomineralization, run by Alexandria University.
Trial summary
Molar Incisor Hypomineralisation (MIH) is a qualitative defect of enamel that shows asymmetrically involvement of one to four on first permanent molars (FPM) with or without incisor teeth involvement. Hypersensitivity is one of the biggest challenges in the treatment of MIH. Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar Incisor Hypomineralization
- What is being tested?
- Photobiomodulation usinf low level laser therapy, Resin-based sealant and Glass ionomer sealant
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Jan 2025
- 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 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 6-10-year-old children (15).
- At least one tooth with MIH and DH reported in the occlusal region with sensitivity equal to or greater than 4 on the Visual analogue Scale (VAS).
- Good overall health (ASA I).
Who cannot join
- First permanent molars with active carious lesions or defective restorations
- Sufficient dentin loss that requires restorative therapy.
- Any clinical signs of failure (abscess, fistula).
- Patients with systemic diseases.
- Having undergone any professional desensitizing treatment in the previous 6 months.
- Having used a desensitizing paste in the previous 3 months.
- Use of anti-inflammatory drugs or analgesics at the time of recruitment.
About this study
Official title: MANAGEMENT OF HYPERSENSITIVITY IN MOLAR INCISOR HYPOMINERALISATION USING LOW LEVEL LASER IN CHILDREN (RANDOMIZED CLINICAL TRIAL)
Molar Incisor Hypomineralisation (MIH) is a qualitative defect of enamel that shows asymmetrically involvement of one to four on first permanent molars (FPM) with or without incisor teeth involvement. Hypersensitivity is one of the biggest challenges in the treatment of MIH. A sample of children having a first permanent molar erupted with MIH and suffering of dentin hypersensitivity (DH). All selected 45 first permanent molars will be randomly equally allocated into three groups. DH will be evaluated after the treatments. The primary outcome of this study is change in pain/sensitivity, when evaluated through a Visual Analogue Scale. OHRQoL will be also assessed for all children through the child perceptions questionnaire (CPQ8-10).
Read the detailed description
Background: Molar Incisor Hypomineralisation (MIH) is a qualitative defect of enamel that shows asymmetrically involvement of one to four on first permanent molars (FPM) with or without incisor teeth involvement. Hypersensitivity is one of the biggest challenges in the treatment of MIH.
Aim of the study: To evaluate the effectiveness of photo biomodulation (PBM) with low-level laser therapy (LLLT) in the management of hypersensitivity in children diagnosed with MIH in comparison to resin-based fissure sealant (Fissured Novo Plus) and glass ionomer sealant (Ketac) and the impact of LLLT on their oral health-related quality of life (OHRQoL).
Materials and Method: A sample of children with an age range of 8-10 years old, having a first permanent molar erupted with MIH and suffering of dentin hypersensitivity (DH), will be selected from the outpatient clinic of Pediatric Dentistry and Public Health Department, Faculty of Dentistry, Alexandria University after securing necessary consents. All selected 45 first permanent molars will be randomly equally allocated into three groups. Group 1(n=15): PBM with LLLT, Group 2 (n=15): Resin-based sealant (Fissured Nova Plus) and Group 3 (n=15): Glass ionomer sealant (Ketac). DH will be evaluated 15 min after the application of the treatments and the patients will be reevaluated 1 week, 1 month, 3 months and 6 months after the treatments. The primary outcome of this study is change in pain/sensitivity, when evaluated through a Visual Analogue Scale, to determine the effectiveness of the proposed treatments, as well as differences among the evaluation times for each proposed treatment. OHRQoL will be also assessed for all children through the child perceptions questionnaire (CPQ8-10) which will be administered at the beginning and the end of the treatment.
Results: The data will be collected, tabulated, and analyzed using suitable statistical tests to achieve the aim of the study.
- Conditions
- Molar Incisor Hypomineralization
- Being tested
- Photobiomodulation usinf low level laser therapy, Resin-based sealant, Glass ionomer sealant
- Keywords
- Molar Incisor Hypomineralisation, Low Level Laser, Sealant, Hypersensitivity
- Medical subject headings
- Molar Hypomineralization, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation usinf low level laser therapyProcedure or surgery
Diode laser will be used (SIROLaser Blue®, Sirona, Germany) at a wavelength of 660 nm and a power of 100 mW for 10 sec, corresponding to an energy dose of 1 J. Irradiation will be performed at the hypomineralized area: two irradiations scanning the surface in the mesiodistal direction and two in the occlusogingival direction (perpendicular to the tooth surface) precisely over the lesion, in a uniform scanning motion with relative isolation. Treatment will be performed in 3 sessions with a 72-hour interval between sessions.
Resin-based sealantProcedure or surgery
Cotton rolls and a four-handed technique will be applied for isolation. Scotchbond Universal will be rubbed in the cleaned surface for 20 seconds and air dried for 5 seconds. Afterwards, Fissured Novo Plus will be applied with a syringe. Before light-curing, the presence of air bubbles will be checked and teased out. Light curing for 40 seconds will be done. Occlusion will be checked using articulating paper and necessary adjustments will be done using finishing burs.
Glass ionomer sealantProcedure or surgery
Fuji triage will be applied after activating and mixing the capsule. Light cure for 20 seconds. Occlusion will be checked using articulating paper and necessary adjustments will be done using finishing burs.
For the duration of the study, children will be instructed to undergo regular tooth brushing and flossing. Any other needed treatment will be done for the child.
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation with low level laser therapy | Experimental | This group will be subjected to photo biomodulation by low level laser therapy. Diode laser will be used (SIROLaser Blue®, Sirona, Germany) at a wavelength of 660 nm and a power of 100 mW for 10 sec, corresponding to an energy dose of 1 J. Irradiation will be performed at the hypomineralized area: two irradiations scanning the surface in the mesiodistal direction and two in the occlusogingival direction (perpendicular to the tooth surface) precisely over the lesion, in a uniform scanning motion with relative isolation. Treatment will be performed in 3 sessions with a 72-hour interval between sessions. During the laser treatments, both the volunteer and operator will use protective eyewear and all rules of safety will be obeyed. Receives: Procedure: Photobiomodulation usinf low level laser therapy |
| light cured resin-based sealant | Active comparator | This group will receive light cured resin-based sealant (Fissured Novo Plus). Cotton rolls and a four-handed technique will be applied for isolation. Scotchbond Universal will be rubbed in the cleaned surface for 20 seconds and air dried for 5 seconds. Afterwards, Fissured Novo Plus will be applied with a syringe. Before light-curing, the presence of air bubbles will be checked and teased out. Light curing for 40 seconds will be done. Occlusion will be checked using articulating paper and necessary adjustments will be done using finishing burs. Receives: Procedure: Resin-based sealant |
| glass ionomer sealant | Active comparator | This group will receive glass ionomer sealant. Fuji triage will be applied after activating and mixing the capsule. Light cure for 20 seconds. Occlusion will be checked using articulating paper and necessary adjustments will be done using finishing burs. Receives: Procedure: Glass ionomer sealant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dentin Hypersensitivity
it will be measures usinf a Faces pain scale
Measured: Day0, 1 week, 1 month, 3 months and 6 months
Secondary outcomes (1)
Oral health related Quality of life (OHRQoL)
OHRQoL will be assessed for all children through the validated Arabic version of the Child Perceptions Questionnaire (CPQ8-10)which will be administered at the beginning and the end of the treatment. The questionnaire evaluates the severity of oral symptoms, functional limitations as well as emotional and social well-being. The questions are measured using a 5-point Likert scale as follows: never = 0, once or twice = 1, sometimes = 2, often = 3, and Every day or almost every day = 4. Hence, total scores range from 0 to100, and higher scores indicate poorer OHRQoL.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study startJan 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (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
- All selected first permanent molars will be randomly equally allocated into three groups. Group 1(n=15): PBM with LLLT, Group 2 (n=15): Resin-based sealant (Fissured Nova Plus) and Group 3 (n=15): Glass ionomer sealant (Ketac).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Baraka, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06154733
- Sponsor's protocol ID
- 0774-09/2023
- Status last verified
- Sep 2023
- First submitted
- 24 Nov 2023
- Last updated
- 4 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MANAGEMENT OF HYPERSENSITIVITY IN MOLAR INCISOR HYPOMINERALISATION USING LOW LEVEL LASER IN CHILDREN (RANDOMIZED CLINICAL TRIAL)
- ClinicalTrials.gov ID
- NCT06154733
- Acronym / sponsor ID
- 0774-09/2023
- Conditions
- Molar Incisor Hypomineralization
- Keywords
- Molar Incisor Hypomineralisation, Low Level Laser, Sealant, Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 4 Dec 2023 (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.
Molar Incisor Hypomineralisation (MIH) is a qualitative defect of enamel that shows asymmetrically involvement of one to four on first permanent molars (FPM) with or without incisor teeth involvement. Hypersensitivity is one of the biggest challenges in the treatment of MIH. A sample of children having a first permanent molar erupted with MIH and suffering of dentin hypersensitivity (DH). All selected 45 first permanent molars will be randomly equally allocated into three groups. DH will be evaluated after the treatments. The primary outcome of this study is change in pain/sensitivity, when evaluated through a Visual Analogue Scale. OHRQoL will be also assessed for all children through the child perceptions questionnaire (CPQ8-10).
Detailed description
Background: Molar Incisor Hypomineralisation (MIH) is a qualitative defect of enamel that shows asymmetrically involvement of one to four on first permanent molars (FPM) with or without incisor teeth involvement. Hypersensitivity is one of the biggest challenges in the treatment of MIH.
Aim of the study: To evaluate the effectiveness of photo biomodulation (PBM) with low-level laser therapy (LLLT) in the management of hypersensitivity in children diagnosed with MIH in comparison to resin-based fissure sealant (Fissured Novo Plus) and glass ionomer sealant (Ketac) and the impact of LLLT on their oral health-related quality of life (OHRQoL).
Materials and Method: A sample of children with an age range of 8-10 years old, having a first permanent molar erupted with MIH and suffering of dentin hypersensitivity (DH), will be selected from the outpatient clinic of Pediatric Dentistry and Public Health Department, Faculty of Dentistry, Alexandria University after securing necessary consents. All selected 45 first permanent molars will be randomly equally allocated into three groups. Group 1(n=15): PBM with LLLT, Group 2 (n=15): Resin-based sealant (Fissured Nova Plus) and Group 3 (n=15): Glass ionomer sealant (Ketac). DH will be evaluated 15 min after the application of the treatments and the patients will be reevaluated 1 week, 1 month, 3 months and 6 months after the treatments. The primary outcome of this study is change in pain/sensitivity, when evaluated through a Visual Analogue Scale, to determine the effectiveness of the proposed treatments, as well as differences among the evaluation times for each proposed treatment. OHRQoL will be also assessed for all children through the child perceptions questionnaire (CPQ8-10) which will be administered at the beginning and the end of the treatment.
Results: The data will be collected, tabulated, and analyzed using suitable statistical tests to achieve the aim of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- All selected first permanent molars will be randomly equally allocated into three groups. Group 1(n=15): PBM with LLLT, Group 2 (n=15): Resin-based sealant (Fissured Nova Plus) and Group 3 (n=15): Glass ionomer sealant (Ketac).
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation with low level laser therapy | Experimental | Procedure: Photobiomodulation usinf low level laser therapyThis group will be subjected to photo biomodulation by low level laser therapy. Diode laser will be used (SIROLaser Blue®, Sirona, Germany) at a wavelength of 660 nm and a power of 100 mW for 10 sec, corresponding to an energy dose of 1 J. Irradiation will be performed at the hypomineralized area: two irradiations scanning the surface in the mesiodistal direction and two in the occlusogingival direction (perpendicular to the tooth surface) precisely over the lesion, in a uniform scanning motion with relative isolation. Treatment will be performed in 3 sessions with a 72-hour interval between sessions. During the laser treatments, both the volunteer and operator will use protective eyewear and all rules of safety will be obeyed. |
| light cured resin-based sealant | Active comparator | Procedure: Resin-based sealantThis group will receive light cured resin-based sealant (Fissured Novo Plus). Cotton rolls and a four-handed technique will be applied for isolation. Scotchbond Universal will be rubbed in the cleaned surface for 20 seconds and air dried for 5 seconds. Afterwards, Fissured Novo Plus will be applied with a syringe. Before light-curing, the presence of air bubbles will be checked and teased out. Light curing for 40 seconds will be done. Occlusion will be checked using articulating paper and necessary adjustments will be done using finishing burs. |
| glass ionomer sealant | Active comparator | Procedure: Glass ionomer sealantThis group will receive glass ionomer sealant. Fuji triage will be applied after activating and mixing the capsule. Light cure for 20 seconds. Occlusion will be checked using articulating paper and necessary adjustments will be done using finishing burs. |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 6-10-year-old children (15).
- At least one tooth with MIH and DH reported in the occlusal region with sensitivity equal to or greater than 4 on the Visual analogue Scale (VAS).
- Good overall health (ASA I).
Key exclusion criteria (7 listed)
- First permanent molars with active carious lesions or defective restorations
- Sufficient dentin loss that requires restorative therapy.
- Any clinical signs of failure (abscess, fistula).
- Patients with systemic diseases.
- Having undergone any professional desensitizing treatment in the previous 6 months.
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 usinf low level laser therapyDiode laser will be used (SIROLaser Blue®, Sirona, Germany) at a wavelength of 660 nm and a power of 100 mW for 10 sec, corresponding to an energy dose of 1 J. Irradiation will be performed at the hypomineralized area: two irradiations scanning the surface in the mesiodistal direction and two in the occlusogingival direction (perpendicular to the tooth surface) precisely over the lesion, in a uniform scanning motion with relative isolation. Treatment will be performed in 3 sessions with a 72-hour interval between sessions. | Procedure or surgery | Photobiomodulation with low level laser therapy |
| Resin-based sealantCotton rolls and a four-handed technique will be applied for isolation. Scotchbond Universal will be rubbed in the cleaned surface for 20 seconds and air dried for 5 seconds. Afterwards, Fissured Novo Plus will be applied with a syringe. Before light-curing, the presence of air bubbles will be checked and teased out. Light curing for 40 seconds will be done. Occlusion will be checked using articulating paper and necessary adjustments will be done using finishing burs. | Procedure or surgery | light cured resin-based sealant |
| Glass ionomer sealantFuji triage will be applied after activating and mixing the capsule. Light cure for 20 seconds. Occlusion will be checked using articulating paper and necessary adjustments will be done using finishing burs. For the duration of the study, children will be instructed to undergo regular tooth brushing and flossing. Any other needed treatment will be done for the child. | Procedure or surgery | glass ionomer sealant |
Primary outcome
Dentin Hypersensitivity
Time frame: Day0, 1 week, 1 month, 3 months and 6 months
it will be measures usinf a Faces pain scale
1 secondary outcome
Oral health related Quality of life (OHRQoL)
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Molar Incisor Hypomineralization
Not yet recruiting
Clinical Performance of Glass Hybrid and Alkasite Restorative Systems in MIH-Affected Permanent First Molars
Molar-Incisor Hypomineralization (MIH)
Recruiting
Nanohydroxyapatite Versus Sodium Fluoride Varnish in Remineralizing MIH Anterior Teeth
Fluoride Varnishes, Molar Incisor Hypomineralisation
Recruiting
Molar-Incisor Hypomineralization and Resin Infiltration
Molar Incisor Hypomineralization
Active, not recruiting
Pain Assessment Governing Partial or Full Pulpotomy of Immature Molars With Irreversible Pulpitis in Molar Incisor Hypomineralization
Molar Incisor Hypomineralisation, Irreversible Pulpitis
Not yet recruiting
Nano Silver Fluoride and Photobiomodulation Therapy for Hypersensitivity and Pain in MIH-Affected Molars
Molar-Incisor Hypomineralization (MIH)
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.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation usinf low level laser therapy, Resin-based sealant and Glass ionomer sealant in people with Molar Incisor Hypomineralization, run by Alexandria University.
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 7 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: status not confirmed, as of the sponsor's last update on 4 Dec 2023. 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?
Results are not available in the source record.
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?
Dentin Hypersensitivity (time frame: Day0, 1 week, 1 month, 3 months 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 4 Dec 2023.