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NCT Number: NCT07826130

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Hypersensitivity

    Time frame: Baseline, 15 minutes after intervention, and 15 days after intervention.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hend Seif El Din

CONTACT

[email protected]

01017907339 ext. 002

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study 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.

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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