Molar-Incisor Hypomineralization (MIH)NCT07826130
Nano Silver Fluoride and Photobiomodulation Therapy for Hypersensitivity and Pain in MIH-Affected Molars
A study testing Nano Silver Fluoride, Photobiomodulation Therapy and Pre-appointment analgesics in people with Molar-Incisor Hypomineralization (MIH), run by Ain Shams University.
Trial summary
Molar-incisor hypomineralization (MIH) is a developmental condition affecting primarily the first permanent molars and may be associated with post-eruptive enamel breakdown, hypersensitivity, and difficulties in achieving adequate pain control during dental treatment. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Molar-Incisor Hypomineralization (MIH)
- What is being tested?
- Nano Silver Fluoride, Photobiomodulation Therapy and Pre-appointment analgesics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2027to 1 Dec 2028
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 7-12 years diagnosed with molar-incisor hypomineralization (MIH) in first permanent molars according to the European Academy of Paediatric Dentistry (EAPD) criteria.
- MIH-affected teeth exhibiting demarcated opacity, post-eruptive structural loss of enamel, and hypersensitivity (Treatment Need Index = 4).
- Children who are able to cooperate during treatment and attend scheduled follow-up visits.
- Children whose parents or legal guardians provide informed consent for participation in the study.
Who cannot join
- Hypomineralized molars caused by other conditions, including syndromes, fluorosis, enamel hypoplasia, amelogenesis imperfecta, or dental caries.
- Teeth with defective restorations or pulpal symptoms.
- History of desensitizing treatment within the previous 6 months.
- Use of anti-inflammatory drugs or analgesics at the time of recruitment.
- Children who are physically or mentally disabled or who have a medical condition that may complicate treatment.
- Reported allergy to silver or any material included in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of Nano Silver Fluoride and Photobiomodualtion Therapy on Hypersensitivity and Pain During Cavity Preparation and The Restoration Outcomes in Molars Affected by Molar Incisor Hypomineralization: A Randomized Controlled Trial.
Molar-incisor hypomineralization (MIH) is a developmental condition affecting primarily the first permanent molars and may be associated with post-eruptive enamel breakdown, hypersensitivity, and difficulties in achieving adequate pain control during dental treatment.
This randomized controlled trial will evaluate the effectiveness of nano silver fluoride (NSF) and photobiomodulation therapy (PBMT) as desensitizing interventions applied before cavity preparation in children aged 7-12 years with MIH-affected first permanent molars with post-eruptive enamel breakdown. The study will compare the effects of NSF and PBMT with a control group receiving pre-appointment analgesics.
Hypersensitivity will be assessed using the Cumulative Hypersensitivity Index (CHI), while pain during cavity preparation and restoration will be evaluated using the Wong-Baker FACES Pain Rating Scale and pulse rate monitoring. All treated molars will receive glass ionomer cement restorations, which will subsequently be evaluated using the Modified United States Public Health Service (USPHS) criteria at 3, 6, and 12 months.
Read the detailed description
Molar-incisor hypomineralization (MIH) is a developmental condition primarily affecting the enamel of the first permanent molars. Affected teeth may exhibit demarcated opacities, post-eruptive structural loss of enamel, hypersensitivity, and difficulties during restorative treatment.
This study will evaluate the effect of using nano silver fluoride (NSF) and photobiomodulation therapy (PBMT) as desensitizing agents prior to cavity preparation in permanent molars affected by MIH with post-eruptive enamel breakdown.
A total of 45 children aged 7-12 years will be included and randomly assigned to three groups, with 15 participants in each group:
Group A: Nano silver fluoride (NSF). The affected molar will receive a single application of NSF 15 days before cavity preparation and restoration.
Group B: Photobiomodulation therapy (PBMT). The affected molar will receive PBMT 15 days before cavity preparation and restoration using a low-level diode laser with a wavelength of 980 nm and a power output of 100 mW.
Group C: Control group. Participants will receive oral hygiene instructions and pre-appointment analgesics before cavity preparation and restoration.
For the NSF group, hypersensitivity will be assessed at baseline and 15 minutes after application, and again after 15 days. For the PBMT group, hypersensitivity will similarly be assessed at baseline, 15 minutes after treatment, and after 15 days. The control group will undergo baseline assessment and receive the planned pre-appointment analgesic regimen.
At the second visit, hypersensitivity will be reassessed, followed by conventional cavity preparation and restoration. Pain during the procedure will be assessed using the Wong-Baker FACES Pain Rating Scale and pulse rate monitoring.
All molars will be restored using glass ionomer cement (GC Equia Forte HT). The restorations will be clinically evaluated at 3, 6, and 12 months using the Modified United States Public Health Service (USPHS) criteria.
The study will be conducted at the outpatient clinic of the Department of Pediatric Dentistry and Dental Public Health and the Laser Unit, Faculty of Dentistry, Ain Shams University.
- Conditions
- Molar-Incisor Hypomineralization (MIH)
- Being tested
- Nano Silver Fluoride, Photobiomodulation Therapy, Pre-appointment analgesics
- Keywords
- Molar-Incisor Hypomineralization (MIH), Nano Silver Fluoride (NSF), Photobiomodulation Therapy (PBMT), Low-Level Laser Therapy (LLLT), Post-Eruptive Enamel Breakdown (PEB)
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nano Silver FluorideOther
Participants assigned to this group will receive a single application of nano silver fluoride (NSF) to the affected first permanent molar 15 days before cavity preparation and restoration.
The tooth will be isolated using cotton rolls and suction, and plaque or gross debris will be removed. A single drop of NSF solution will be dispensed into a plastic dappen dish and applied to the entire lesion using a disposable microbrush. Excess solution will be removed with a cotton swab. The solution will remain in contact with the tooth surface for 1 minute. Hypersensitivity will be assessed at baseline and 15 minutes after application, and again after 15 days before cavity preparation and restoration.
Photobiomodulation TherapyOther
A low-level diode laser with a wavelength of 980 nm and a power output of 100 mW will be used. The laser tip will be positioned perpendicular to three points: mesial and distal to the cervical region and the central part of the tooth lesion or opacity. Each irradiation point will receive laser exposure for 20 seconds, delivering a total energy dose of 2 J. Standard laser safety measures, including protective eyewear for the patient and operator, will be implemented.
Hypersensitivity will be assessed at baseline, 15 minutes after laser application, and again after 15 days before cavity preparation and restoration.
Pre-appointment analgesicsDrug
Participants assigned to the control group will receive oral hygiene instructions and a prescription for pre-appointment analgesics before cavity preparation and restoration. Hypersensitivity will be assessed at baseline. At the second visit, hypersensitivity will be reassessed, followed by conventional cavity preparation and restoration. Pain during the procedure will be evaluated using the Wong-Baker FACES Pain Rating Scale and pulse rate monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Nano Silver Fluoride | Experimental | Participants assigned to this group will receive a single application of nano silver fluoride (NSF) to the affected first permanent molar 15 days before cavity preparation and restoration.
The tooth will be isolated using cotton rolls and suction, and plaque or gross debris will be removed. A single drop of NSF solution will be dispensed into a plastic dappen dish and applied to the entire lesion using a disposable microbrush. Excess solution will be removed with a cotton swab. The solution will remain in contact with the tooth surface for 1 minute. Hypersensitivity will be assessed at baseline and 15 minutes after application, and again after 15 days before cavity preparation and restoration. Receives: Other: Nano Silver Fluoride |
| Photobiomodulation Therapy | Experimental | Participants assigned to this group will receive photobiomodulation therapy (PBMT) 15 days before cavity preparation and restoration.
A low-level diode laser with a wavelength of 980 nm and a power output of 100 mW will be used. The laser tip will be positioned perpendicular to three points: mesial and distal to the cervical region and the central part of the tooth lesion or opacity. Each irradiation point will receive laser exposure for 20 seconds, delivering a total energy dose of 2 J. Standard laser safety measures, including protective eyewear for the patient and operator, will be implemented.
Hypersensitivity will be assessed at baseline, 15 minutes after laser application, and again after 15 days before cavity preparation and restoration. Receives: Other: Photobiomodulation Therapy |
| Control | Active comparator | Participants assigned to the control group will receive oral hygiene instructions and a prescription for pre-appointment analgesics before cavity preparation and restoration. Hypersensitivity will be assessed at baseline. At the second visit, hypersensitivity will be reassessed, followed by conventional cavity preparation and restoration. Pain during the procedure will be evaluated using the Wong-Baker FACES Pain Rating Scale and pulse rate monitoring. Receives: Drug: Pre-appointment analgesics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain During Cavity Preparation and Restoration
Pain during cavity preparation and restoration will be assessed using the Wong-Baker FACES Pain Rating Scale and pulse rate monitoring.
Measured: During the cavity preparation and restoration procedure at the second visit, 15 days after application of the assigned desensitizing intervention.
Secondary outcomes (1)
Hypersensitivity
Hypersensitivity will be assessed using the Cumulative Hypersensitivity Index (CHI) at baseline, 15 minutes after application of the assigned intervention, and 15 days after intervention.
Measured: Baseline, 15 minutes after intervention, and 15 days after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start1 May 2027 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Molar-Incisor Hypomineralization (MIH)Studies of the same condition, open and under way.
- More trials run by Ain Shams 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07826130
- Sponsor's protocol ID
- FDASU-Rec ID062505
- Status last verified
- Aug 2026
- First submitted
- 13 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Osman SA, Elmasry ES, Abd Al Gawad RY. Prevalence of Molar Incisor Hypominerlization among a Group of Egyptian Children: A Cross Sectional Study. Egypt Dent J. 2020;66(4):2021-2028. doi:10.21608/edj.2020.40437.1222.
Olley RC, Wilson R, Moazzez R, Bartlett D. Validation of a Cumulative Hypersensitivity Index (CHI) for dentine hypersensitivity severity. J Clin Periodontol. 2013 Oct;40(10):942-7. doi: 10.1111/jcpe.12144. Epub 2013 Aug 19.
PubMed 23998374Al-Nerabieah Z, AlKhouli M, Dashash M. Preventive efficacy of 38% silver diamine fluoride and CPP-ACP fluoride varnish on molars affected by molar incisor hypomineralization in children: A randomized controlled trial. F1000Res. 2024 May 7;12:1052. doi: 10.12688/f1000research.136653.3. eCollection 2023.
PubMed 38778809Nabil 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 40716831Muniz RSC, Carvalho CN, Aranha ACC, Dias FMCS, Ferreira MC. Efficacy of low-level laser therapy associated with fluoride therapy for the desensitisation of molar-incisor hypomineralisation: Randomised clinical trial. Int J Paediatr Dent. 2020 May;30(3):323-333. doi: 10.1111/ipd.12602. Epub 2019 Dec 23.
PubMed 31808584da Silva FG, de Almeida SB, de Campos PH, Abrantes RM, de Oliveira AVA, Guare RO, Diniz MB. Low-Level Laser Therapy for Management of Hypersensitivity in Molar-Incisor Hypomineralization and Oral Health-Related Quality of Life: Case Report. J Clin Pediatr Dent. 2022 Mar 1;46(2):107-111. doi: 10.17796/1053-4625-46.2.3.
PubMed 35533226Lygidakis NA, Garot E, Somani C, Taylor GD, Rouas P, Wong FSL. Best clinical practice guidance for clinicians dealing with children presenting with molar-incisor-hypomineralisation (MIH): an updated European Academy of Paediatric Dentistry policy document. Eur Arch Paediatr Dent. 2022 Feb;23(1):3-21. doi: 10.1007/s40368-021-00668-5. Epub 2021 Oct 20.
PubMed 34669177Elhennawy K, Manton DJ, Crombie F, Zaslansky P, Radlanski RJ, Jost-Brinkmann PG, Schwendicke F. Structural, mechanical and chemical evaluation of molar-incisor hypomineralization-affected enamel: A systematic review. Arch Oral Biol. 2017 Nov;83:272-281. doi: 10.1016/j.archoralbio.2017.08.008. Epub 2017 Aug 19.
PubMed 28843745Americano GC, Jacobsen PE, Soviero VM, Haubek D. A systematic review on the association between molar incisor hypomineralization and dental caries. Int J Paediatr Dent. 2017 Jan;27(1):11-21. doi: 10.1111/ipd.12233. Epub 2016 Apr 21.
PubMed 27098755Fagrell T. Molar incisor hypomineralization. Morphological and chemical aspects, onset and possible etiological factors. Swed Dent J Suppl. 2011;(216):5, 11-83.
PubMed 22338967Santos PS, Vitali FC, Fonseca-Souza G, Maia LC, Cardoso M, Feltrin-Souza J, Fraiz FC. Dentin hypersensitivity and toothache among patients diagnosed with Molar-Incisor Hypomineralization: A systematic review and meta-analysis. J Dent. 2024 Jun;145:104981. doi: 10.1016/j.jdent.2024.104981. Epub 2024 Apr 4.
PubMed 38582436Saber F, Waly N, Moheb D. Prevalence of molar incisor hypomineralisation in a group of Egyptian children using the short form: a cross-sectional study. Eur Arch Paediatr Dent. 2018 Oct;19(5):337-345. doi: 10.1007/s40368-018-0364-6. Epub 2018 Sep 3.
PubMed 30178292Dave M, Taylor G. Global prevalence of molar incisor hypomineralisation. Evid Based Dent. 2018 Oct;19(3):78-79. doi: 10.1038/sj.ebd.6401324.
PubMed 30361661Garot E, Rouas P, Somani C, Taylor GD, Wong F, Lygidakis NA. An update of the aetiological factors involved in molar incisor hypomineralisation (MIH): a systematic review and meta-analysis. Eur Arch Paediatr Dent. 2022 Feb;23(1):23-38. doi: 10.1007/s40368-021-00646-x. Epub 2021 Jun 24.
PubMed 34164793Vieira AR. On the genetics contribution to molar incisor hypomineralization. Int J Paediatr Dent. 2019 Jan;29(1):2-3. doi: 10.1111/ipd.12439. Epub 2018 Oct 26. No abstract available.
PubMed 30367537
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Nano Silver Fluoride and Photobiomodualtion Therapy on Hypersensitivity and Pain During Cavity Preparation and The Restoration Outcomes in Molars Affected by Molar Incisor Hypomineralization: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07826130
- Acronym / sponsor ID
- FDASU-Rec ID062505
- Conditions
- Molar-Incisor Hypomineralization (MIH)
- Keywords
- Molar-Incisor Hypomineralization (MIH), Nano Silver Fluoride (NSF), Photobiomodulation Therapy (PBMT), Low-Level Laser Therapy (LLLT), Post-Eruptive Enamel Breakdown (PEB)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 May 2027 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 17 Sep 2026 (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 hypomineralization (MIH) is a developmental condition affecting primarily the first permanent molars and may be associated with post-eruptive enamel breakdown, hypersensitivity, and difficulties in achieving adequate pain control during dental treatment.
This randomized controlled trial will evaluate the effectiveness of nano silver fluoride (NSF) and photobiomodulation therapy (PBMT) as desensitizing interventions applied before cavity preparation in children aged 7-12 years with MIH-affected first permanent molars with post-eruptive enamel breakdown. The study will compare the effects of NSF and PBMT with a control group receiving pre-appointment analgesics.
Hypersensitivity will be assessed using the Cumulative Hypersensitivity Index (CHI), while pain during cavity preparation and restoration will be evaluated using the Wong-Baker FACES Pain Rating Scale and pulse rate monitoring. All treated molars will receive glass ionomer cement restorations, which will subsequently be evaluated using the Modified United States Public Health Service (USPHS) criteria at 3, 6, and 12 months.
Detailed description
Molar-incisor hypomineralization (MIH) is a developmental condition primarily affecting the enamel of the first permanent molars. Affected teeth may exhibit demarcated opacities, post-eruptive structural loss of enamel, hypersensitivity, and difficulties during restorative treatment.
This study will evaluate the effect of using nano silver fluoride (NSF) and photobiomodulation therapy (PBMT) as desensitizing agents prior to cavity preparation in permanent molars affected by MIH with post-eruptive enamel breakdown.
A total of 45 children aged 7-12 years will be included and randomly assigned to three groups, with 15 participants in each group:
Group A: Nano silver fluoride (NSF). The affected molar will receive a single application of NSF 15 days before cavity preparation and restoration.
Group B: Photobiomodulation therapy (PBMT). The affected molar will receive PBMT 15 days before cavity preparation and restoration using a low-level diode laser with a wavelength of 980 nm and a power output of 100 mW.
Group C: Control group. Participants will receive oral hygiene instructions and pre-appointment analgesics before cavity preparation and restoration.
For the NSF group, hypersensitivity will be assessed at baseline and 15 minutes after application, and again after 15 days. For the PBMT group, hypersensitivity will similarly be assessed at baseline, 15 minutes after treatment, and after 15 days. The control group will undergo baseline assessment and receive the planned pre-appointment analgesic regimen.
At the second visit, hypersensitivity will be reassessed, followed by conventional cavity preparation and restoration. Pain during the procedure will be assessed using the Wong-Baker FACES Pain Rating Scale and pulse rate monitoring.
All molars will be restored using glass ionomer cement (GC Equia Forte HT). The restorations will be clinically evaluated at 3, 6, and 12 months using the Modified United States Public Health Service (USPHS) criteria.
The study will be conducted at the outpatient clinic of the Department of Pediatric Dentistry and Dental Public Health and the Laser Unit, Faculty of Dentistry, Ain Shams University.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nano Silver Fluoride | Experimental | Other: Nano Silver FluorideParticipants assigned to this group will receive a single application of nano silver fluoride (NSF) to the affected first permanent molar 15 days before cavity preparation and restoration. The tooth will be isolated using cotton rolls and suction, and plaque or gross debris will be removed. A single drop of NSF solution will be dispensed into a plastic dappen dish and applied to the entire lesion using a disposable microbrush. Excess solution will be removed with a cotton swab. The solution will remain in contact with the tooth surface for 1 minute. Hypersensitivity will be assessed at baseline and 15 minutes after application, and again after 15 days before cavity preparation and restoration. |
| Photobiomodulation Therapy | Experimental | Other: Photobiomodulation TherapyParticipants assigned to this group will receive photobiomodulation therapy (PBMT) 15 days before cavity preparation and restoration. A low-level diode laser with a wavelength of 980 nm and a power output of 100 mW will be used. The laser tip will be positioned perpendicular to three points: mesial and distal to the cervical region and the central part of the tooth lesion or opacity. Each irradiation point will receive laser exposure for 20 seconds, delivering a total energy dose of 2 J. Standard laser safety measures, including protective eyewear for the patient and operator, will be implemented. Hypersensitivity will be assessed at baseline, 15 minutes after laser application, and again after 15 days before cavity preparation and restoration. |
| Control | Active comparator | Drug: Pre-appointment analgesicsParticipants assigned to the control group will receive oral hygiene instructions and a prescription for pre-appointment analgesics before cavity preparation and restoration. Hypersensitivity will be assessed at baseline. At the second visit, hypersensitivity will be reassessed, followed by conventional cavity preparation and restoration. Pain during the procedure will be evaluated using the Wong-Baker FACES Pain Rating Scale and pulse rate monitoring. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 7-12 years diagnosed with molar-incisor hypomineralization (MIH) in first permanent molars according to the European Academy of Paediatric Dentistry (EAPD) criteria.
- MIH-affected teeth exhibiting demarcated opacity, post-eruptive structural loss of enamel, and hypersensitivity (Treatment Need Index = 4).
- Children who are able to cooperate during treatment and attend scheduled follow-up visits.
- Children whose parents or legal guardians provide informed consent for participation in the study.
Key exclusion criteria (6 listed)
- Hypomineralized molars caused by other conditions, including syndromes, fluorosis, enamel hypoplasia, amelogenesis imperfecta, or dental caries.
- Teeth with defective restorations or pulpal symptoms.
- History of desensitizing treatment within the previous 6 months.
- Use of anti-inflammatory drugs or analgesics at the time of recruitment.
- Children who are physically or mentally disabled or who have a medical condition that may complicate 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 |
|---|---|---|
| Nano Silver FluorideParticipants assigned to this group will receive a single application of nano silver fluoride (NSF) to the affected first permanent molar 15 days before cavity preparation and restoration. The tooth will be isolated using cotton rolls and suction, and plaque or gross debris will be removed. A single drop of NSF solution will be dispensed into a plastic dappen dish and applied to the entire lesion using a disposable microbrush. Excess solution will be removed with a cotton swab. The solution will remain in contact with the tooth surface for 1 minute. Hypersensitivity will be assessed at baseline and 15 minutes after application, and again after 15 days before cavity preparation and restoration. | Other | Nano Silver Fluoride |
| Photobiomodulation TherapyA low-level diode laser with a wavelength of 980 nm and a power output of 100 mW will be used. The laser tip will be positioned perpendicular to three points: mesial and distal to the cervical region and the central part of the tooth lesion or opacity. Each irradiation point will receive laser exposure for 20 seconds, delivering a total energy dose of 2 J. Standard laser safety measures, including protective eyewear for the patient and operator, will be implemented. Hypersensitivity will be assessed at baseline, 15 minutes after laser application, and again after 15 days before cavity preparation and restoration. | Other | Photobiomodulation Therapy |
| Pre-appointment analgesicsParticipants assigned to the control group will receive oral hygiene instructions and a prescription for pre-appointment analgesics before cavity preparation and restoration. Hypersensitivity will be assessed at baseline. At the second visit, hypersensitivity will be reassessed, followed by conventional cavity preparation and restoration. Pain during the procedure will be evaluated using the Wong-Baker FACES Pain Rating Scale and pulse rate monitoring. | Drug | Control |
Primary outcome
Pain During Cavity Preparation and Restoration
Time frame: During the cavity preparation and restoration procedure at the second visit, 15 days after application of the assigned desensitizing intervention.
Pain during cavity preparation and restoration will be assessed using the Wong-Baker FACES Pain Rating Scale and pulse rate monitoring.
1 secondary outcome
Hypersensitivity
Time frame: Baseline, 15 minutes after intervention, and 15 days after intervention.
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 17 Sep 2026.
- BackgroundOsman SA, Elmasry ES, Abd Al Gawad RY. Prevalence of Molar Incisor Hypominerlization among a Group of Egyptian Children: A Cross Sectional Study. Egypt Dent J. 2020;66(4):2021-2028. doi:10.21608/edj.2020.40437.1222.
- Background: PubMed 23998374Olley RC, Wilson R, Moazzez R, Bartlett D. Validation of a Cumulative Hypersensitivity Index (CHI) for dentine hypersensitivity severity. J Clin Periodontol. 2013 Oct;40(10):942-7. doi: 10.1111/jcpe.12144. Epub 2013 Aug 19.
- Background: PubMed 38778809Al-Nerabieah Z, AlKhouli M, Dashash M. Preventive efficacy of 38% silver diamine fluoride and CPP-ACP fluoride varnish on molars affected by molar incisor hypomineralization in children: A randomized controlled trial. F1000Res. 2024 May 7;12:1052. doi: 10.12688/f1000research.136653.3. eCollection 2023.
- Background: 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.
- Background: PubMed 31808584Muniz RSC, Carvalho CN, Aranha ACC, Dias FMCS, Ferreira MC. Efficacy of low-level laser therapy associated with fluoride therapy for the desensitisation of molar-incisor hypomineralisation: Randomised clinical trial. Int J Paediatr Dent. 2020 May;30(3):323-333. doi: 10.1111/ipd.12602. Epub 2019 Dec 23.
- Background: PubMed 35533226da Silva FG, de Almeida SB, de Campos PH, Abrantes RM, de Oliveira AVA, Guare RO, Diniz MB. Low-Level Laser Therapy for Management of Hypersensitivity in Molar-Incisor Hypomineralization and Oral Health-Related Quality of Life: Case Report. J Clin Pediatr Dent. 2022 Mar 1;46(2):107-111. doi: 10.17796/1053-4625-46.2.3.
- Background: PubMed 34669177Lygidakis NA, Garot E, Somani C, Taylor GD, Rouas P, Wong FSL. Best clinical practice guidance for clinicians dealing with children presenting with molar-incisor-hypomineralisation (MIH): an updated European Academy of Paediatric Dentistry policy document. Eur Arch Paediatr Dent. 2022 Feb;23(1):3-21. doi: 10.1007/s40368-021-00668-5. Epub 2021 Oct 20.
- Background: PubMed 28843745Elhennawy K, Manton DJ, Crombie F, Zaslansky P, Radlanski RJ, Jost-Brinkmann PG, Schwendicke F. Structural, mechanical and chemical evaluation of molar-incisor hypomineralization-affected enamel: A systematic review. Arch Oral Biol. 2017 Nov;83:272-281. doi: 10.1016/j.archoralbio.2017.08.008. Epub 2017 Aug 19.
- Background: PubMed 27098755Americano GC, Jacobsen PE, Soviero VM, Haubek D. A systematic review on the association between molar incisor hypomineralization and dental caries. Int J Paediatr Dent. 2017 Jan;27(1):11-21. doi: 10.1111/ipd.12233. Epub 2016 Apr 21.
- Background: PubMed 22338967Fagrell T. Molar incisor hypomineralization. Morphological and chemical aspects, onset and possible etiological factors. Swed Dent J Suppl. 2011;(216):5, 11-83.
- Background: PubMed 38582436Santos PS, Vitali FC, Fonseca-Souza G, Maia LC, Cardoso M, Feltrin-Souza J, Fraiz FC. Dentin hypersensitivity and toothache among patients diagnosed with Molar-Incisor Hypomineralization: A systematic review and meta-analysis. J Dent. 2024 Jun;145:104981. doi: 10.1016/j.jdent.2024.104981. Epub 2024 Apr 4.
- Background: PubMed 30178292Saber F, Waly N, Moheb D. Prevalence of molar incisor hypomineralisation in a group of Egyptian children using the short form: a cross-sectional study. Eur Arch Paediatr Dent. 2018 Oct;19(5):337-345. doi: 10.1007/s40368-018-0364-6. Epub 2018 Sep 3.
- Individual participant dataSharing planned: No
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Molar Incisor Hypomineralization
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.
Questions about this trial
What is this clinical trial studying?
A study testing Nano Silver Fluoride, Photobiomodulation Therapy and Pre-appointment analgesics in people with Molar-Incisor Hypomineralization (MIH), run by Ain Shams 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 4 inclusion and 6 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 17 Sep 2026. 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?
Contact Hend Seif El Din (01017907339 ext. 002, HendAttia@dent.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain During Cavity Preparation and Restoration (time frame: During the cavity preparation and restoration procedure at the second visit, 15 days after application of the assigned desensitizing intervention.). 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 NCT07826130, which also lists 16 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 17 Sep 2026.