Nano Silver Fluoride and Photobiomodulation Therapy for Hypersensitivity and Pain in MIH-Affected Molars

NCT07826130 | Not Yet Recruiting

• 1 other identifier: FDASU-Rec ID062505
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

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)

Outcome Measures

Primary Outcomes (1)

• 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.

  During the cavity preparation and restoration procedure at the second visit, 15 days after application of the assigned desensitizing intervention.

Secondary Outcomes (1)

• Hypersensitivity

  Baseline, 15 minutes after intervention, and 15 days after intervention.

Study Arms (3)

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.

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.

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.

Drug: Pre-appointment analgesics

Interventions

Nano Silver Fluoride OTHER

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.

Nano Silver Fluoride

Photobiomodulation Therapy OTHER

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.

Photobiomodulation Therapy

Pre-appointment analgesics DRUG

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.

Control

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Related Publications (16)

• 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.

  BACKGROUND

• 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.

  PMID: 23998374 BACKGROUND

• Al-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.

  PMID: 38778809 BACKGROUND

• 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.

  PMID: 40716831 BACKGROUND

• Muniz 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.

  PMID: 31808584 BACKGROUND

• da 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.

  PMID: 35533226 BACKGROUND

• Lygidakis 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.

  PMID: 34669177 BACKGROUND

• Elhennawy 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.

  PMID: 28843745 BACKGROUND

• Americano 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.

  PMID: 27098755 BACKGROUND

• Fagrell T. Molar incisor hypomineralization. Morphological and chemical aspects, onset and possible etiological factors. Swed Dent J Suppl. 2011;(216):5, 11-83.

  PMID: 22338967 BACKGROUND

• Santos 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.

  PMID: 38582436 BACKGROUND

• Saber 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.

  PMID: 30178292 BACKGROUND

• Dave M, Taylor G. Global prevalence of molar incisor hypomineralisation. Evid Based Dent. 2018 Oct;19(3):78-79. doi: 10.1038/sj.ebd.6401324.

  PMID: 30361661 BACKGROUND

• Garot 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.

  PMID: 34164793 BACKGROUND

• Vieira 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.

  PMID: 30367537 BACKGROUND

• Rodd HD, Graham A, Tajmehr N, Timms L, Hasmun N. Molar Incisor Hypomineralisation: Current Knowledge and Practice. Int Dent J. 2021 Aug;71(4):285-291. doi: 10.1111/idj.12624. Epub 2021 Jan 27.

  PMID: 34286697 BACKGROUND

MeSH Terms

Conditions

Molar Hypomineralization

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Central Study Contacts

Hend Seif El Din

CONTACT

01017907339; HendAttia@dent.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2026
• First Posted: September 17, 2026
• Study Start (Estimated): May 1, 2027
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share