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Comparison of the efficacy of a combination of non-invasive interventions (glass ionomer sealant, fluoride varnish and topical crème with casein phosphopeptide amorphous calcium phosphate) to reduce dental hypersensitivity among Mexican children with sensitivity in teeth due to molar incisor hypomineralisation: randomized controlled study.

Sensitivity in teeth affected by molar incisor hypomineralisation (MIH) in Mexican children: a clinical controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2023/020
Enrollment
Unknown
Registered
2023-10-30
Start date
2023-12-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Molar incisor hypomineralisation

Interventions

The participants will be divided into four intervention groups using a randomisation list generated by a website (http://www.randomization.com) A, B, C and D: Group A: Glass-ionomer sealant 0.30 g (Fu
GC Corp., Japan) twice-a-day for 12 weeks. Group C: Glass-ionomer sealant (Fuji TRIAGE pink) placed onto MIH-affected molars that show hypersensitivity, professional topical application of 5% sodium

Sponsors

Nakao Foundation (Japan)
Lead Sponsor
GC Corporation (Japan)
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: o Children (male and female), aged from 6 to 13 years. o At least one MIH-affected first permanent molar with self-reported hypersensitivity symptoms (to changes in temperature and/or dental brushing) o At least response grade “1” on the Schiff Cold Air Sensitivity Scale SCASS.

Exclusion criteria

Exclusion criteria: o Other developmental defects of enamel such as fluorosis and amelogenesis imperfecta o Teeth of interest with restorations, PEB, or carious lesions classified as score >2 according to the International Caries Detection and Assessment System (ICDAS) o Allergy to milk proteins and/or hydroxybenzoate

Design outcomes

Primary

MeasureTime frame
Proportion of patients with pulp sensitivity measured by SybronEndo’s Elements Diagnostic Unit (Electronic pulp tester and apex locator, Kerr Corp., Switzerland). The intensity of the electric current has a range of 0-80; values 68 will be considered as not sensitive. [Baseline, 4, 8, 12 and 26 weeks following treatment.] Visual Analogue Scale (VAS, Ritter 2006): regarding the participants’ perception of the desensitizing treatment. [Baseline, 4, 8, 12 and 26 weeks following treatment.] Proportion of patients with MIH assessed via the response to stimulation of hypersensitive teeth using a jet of air based on the Schiff Cold Air Sensitivity Scale (SCASS) for 1 s and at a distance of 1 cm and perpendicular to the occlusal surface of the tooth, neighbouring teeth will be shielded with cotton rolls. (Schiff, 2009) The analogue scale scores for the tooth are 0, 1, 2 or 3: “0” – No subjective response to stimulus, “1” – responds but will continue, “2” – responds and moves or requests discontinuation and “3” – Painful response to stimulus, discontinuation requested. [Baseline, 4, 8, 12 and 26 weeks following treatment.]—

Secondary

MeasureTime frame
None []—

Countries

Mexico

Contacts

Public ContactRivera, Maria

PhD candidate UMCG

m.rivera.pacheco@umcg.nl

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026