Molar Incisor HypomineralizationPhase 2/3NCT06348849
The Desensitising Effect of Nanosilver Fluoride in Molar-Incisor Hypomineralisation
A Phase 2/3 study testing Low-level laser therapy and Nanosilver fluoride in people with Molar Incisor Hypomineralization and Hypersensitivity, run by Alexandria University at 1 site in Egypt.
Trial summary
The aim of the current study is to assess the desensitising effect of nanosilver fluoride on first permanent molars (FPMs) in patients with MIH in comparison to low-level laser therapy. Read more about this study
- Who is it for?
- Ages 7 to 10 years
- Conditions the study is for
- Molar Incisor Hypomineralization, Hypersensitivity
- What is being tested?
- Low-level laser therapy and Nanosilver fluoride
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 1 Aug 2024
- Phase
- Phase 2/3
- 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 7 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The presence of at least one hypersensitive first permanent molar in MIH patient (using the Schiff Cold Air Sensitivity Scale (SCASS)).
- Completion of an informed consent to participate in the study.
Who cannot join
- Hypomineralised molars resulting from other medical conditions, such as enamel malformations associated with syndromes, dental fluorosis, enamel hypoplasia, amelogenesis imperfecta, and dental caries.
- The presence of active tooth decay or defective restorations in the tooth under examination which can confound the aetiology of hypersensitivity with pulpitis.
- The presence of pulpal symptoms.
- Having undergone any professional desensitising treatment in the previous 6 months.
- Having used a desensitising paste other than habitual toothpaste in the previous 3 months.
- Use of anti-inflammatory drugs or analgesics at the time of recruitment.
- Allergy or sensitivity to silver or any of the materials included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Desensitising Effect of Nanosilver Fluoride Compared to Low-Level Laser Therapy in Molar-Incisor Hypomineralisation: A Randomised Controlled Clinical Trial
The aim of the current study is to assess the desensitising effect of nanosilver fluoride on first permanent molars (FPMs) in patients with MIH in comparison to low-level laser therapy.
- Conditions
- Molar Incisor Hypomineralization, Hypersensitivity
- Being tested
- Low-level laser therapy, Nanosilver fluoride
- Keywords
- Nanosilver fluoride, Low-level laser therapy, Desensitising, Molar-incisor hypomineralisation, First permanent molars, Pediatric, Clinical trial, Nanosilver, LLLT
- 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.
Low-level laser therapyDevice
Wavelength 980nm (SmartM, Lasotronix, Poland)
Nanosilver fluorideDrug
Optimized synthesis of Nanosilver Fluoride
| Study group | Role | What they receive |
|---|---|---|
| Low-level laser therapy | Active comparator | These hypersensitive molars with MIH will receive low-level laser therapy. Receives: Device: Low-level laser therapy |
| Nanosilver fluoride | Experimental | These hypersensitive molars with MIH will receive nanosilver fluoride treatment. Receives: Drug: Nanosilver fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Desensitising effect in hypersensitive MIH molars
This will be performed using 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: 1 month
Secondary outcomes (2)
Change in the plaque index scores
This will be assessed using the modified plaque index (PlI) of Silness and Löe. Each tooth will be scored from 0 (lowest) to 3 (highest) according to the amount of plaque accumulation. The total score will be determined by calculating the average score of the examined teeth.
Measured: 1 month
Change in children's frequency of toothbrushing
The frequency of toothbrushing will be assessed using a question adapted from the World Health Organization (WHO) questionnaire- child version. The parent will be asked about the number of times his/her child brushes their teeth (never - several times a month - once a week - several times a week - once daily - twice or more daily)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start1 Apr 2024
- Primary completion1 Jun 2024
- Study completion1 Aug 2024
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 Molar Incisor HypomineralizationStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nouran Nabil, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348849
- Sponsor's protocol ID
- 0797-11/2023
- Status last verified
- Jan 2025
- First submitted
- 31 Mar 2024
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nabil N, Sharaf AA, Essawy MM, Soliman RS. The Desensitizing Effect of Nanosilver Fluoride Compared to Photobiomodulation Therapy in Molar-Incisor Hypomineralization: A Randomized Clinical Trial. J Evid Based Dent Pract. 2025 Sep;25(3):102139. doi: 10.1016/j.jebdp.2025.102139. Epub 2025 Mar 14.
PubMed 40716831
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Desensitising Effect of Nanosilver Fluoride Compared to Low-Level Laser Therapy in Molar-Incisor Hypomineralisation: A Randomised Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06348849
- Acronym / sponsor ID
- 0797-11/2023
- Conditions
- Molar Incisor Hypomineralization, Hypersensitivity
- Keywords
- Nanosilver fluoride, Low-level laser therapy, Desensitising, Molar-incisor hypomineralisation, First permanent molars, Pediatric, Clinical trial, Nanosilver
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 5 Apr 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 current study is to assess the desensitising effect of nanosilver fluoride on first permanent molars (FPMs) in patients with MIH in comparison to low-level laser therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-level laser therapy | Active comparator | Device: Low-level laser therapyThese hypersensitive molars with MIH will receive low-level laser therapy. |
| Nanosilver fluoride | Experimental | Drug: Nanosilver fluorideThese hypersensitive molars with MIH will receive nanosilver fluoride treatment. |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- The presence of at least one hypersensitive first permanent molar in MIH patient (using the Schiff Cold Air Sensitivity Scale (SCASS)).
- Completion of an informed consent to participate in the study.
Key exclusion criteria (7 listed)
- Hypomineralised molars resulting from other medical conditions, such as enamel malformations associated with syndromes, dental fluorosis, enamel hypoplasia, amelogenesis imperfecta, and dental caries.
- The presence of active tooth decay or defective restorations in the tooth under examination which can confound the aetiology of hypersensitivity with pulpitis.
- The presence of pulpal symptoms.
- Having undergone any professional desensitising treatment in the previous 6 months.
- Having used a desensitising paste other than habitual toothpaste in the previous 3 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 |
|---|---|---|
| Low-level laser therapyWavelength 980nm (SmartM, Lasotronix, Poland) | Device | Low-level laser therapy |
| Nanosilver fluorideOptimized synthesis of Nanosilver Fluoride | Drug | Nanosilver fluoride |
Primary outcome
Desensitising effect in hypersensitive MIH molars
Time frame: 1 month
This will be performed using 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)
2 secondary outcomes
Change in the plaque index scores
Time frame: 1 month
Change in children's frequency of toothbrushing
Time frame: 1 month
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 30 Jan 2025.
- Derived from this study: PubMed 40716831Nabil N, Sharaf AA, Essawy MM, Soliman RS. The Desensitizing Effect of Nanosilver Fluoride Compared to Photobiomodulation Therapy in Molar-Incisor Hypomineralization: A Randomized Clinical Trial. J Evid Based Dent Pract. 2025 Sep;25(3):102139. doi: 10.1016/j.jebdp.2025.102139. Epub 2025 Mar 14.
- Individual participant dataSharing planned: Undecided
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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 2/3 study testing Low-level laser therapy and Nanosilver fluoride in people with Molar Incisor Hypomineralization and Hypersensitivity, run by Alexandria University at 1 site in Egypt.
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 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: finished, as of the sponsor's last update on 30 Jan 2025. 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 Egypt. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Desensitising effect in hypersensitive MIH molars (time frame: 1 month). 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 NCT06348849, 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 30 Jan 2025.