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Comparison of the impact on quality of life in Mexican children with molar incisor hypomineralisation (HIM) in anterior teeth treated with infiltrative resin and/or bleaching compared to standard care: a quasi-experimental study.

Quality of life in children with molar incisor hypomineralization (MIH) in permanent anterior teeth treated with infiltrative resins: a quasi experimental study.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2023/024
Enrollment
Unknown
Registered
2023-12-21
Start date
2024-01-01
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 in three groups based on the researcher view that resin infiltration alone should improve the aesthetic appearance of their incisors. OR would benefit from bleaching a
MDC Dental, México City, México) and gingival protector will be applied around the gingival cuff to prevent gel leakage (Optradam
Ivoclar,Products Inc., Utah, USA), then 15% hydrochloric acid gel (Icon etch
DMG, Hamburg, Germany) will be applied to the lesion for 120 s, the tooth washed for 30 s using triplex water spray
ethanol applied for 30 s to desiccate the lesion (Icon Dry
DMG, Hamburg, Germany), the effect of the ethanol on lesion translucence will be evaluated (positive or negative), then the infiltrant resin will be applied to the hypomineralised lesion by means of a
DMG Hamburg, Germany), the resin will be light-cured (40 s) one minute after the lesion has ceased improving in translucence – this is estimated at 3 - 4 min for Type 1 lesions or 9 – 10 min for Type

Sponsors

DMG Corporation (Germany)
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 permanent incisor according to EAPD MIH criteria. o Children who view their teeth as unattractive and wish for aesthetic improvement (at least one permanent incisor that is affecting dental aesthetics)

Exclusion criteria

Exclusion criteria: o Other developmental defects of enamel such as fluorosis, diffuse opacities, hypoplasia or 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
To evaluate the impact of this condition on oral health quality-of-life (OHQoL), using the Parental-caregiver perceptions of child OHQoL P-CPQ (for ages 6 to 14 years; Jokovic et al., 2003, Peruvian Spanish version 2013) This questionnaire has 31 items divided into four sub-scales: oral symptoms (6 items), functional limitations (8 items), emotional wellbeing (7 items) and social wellbeing (10 items). A five-point Likert scale will be used, 0 – never; 1 - once/twice; 2 – sometimes; 3 – often; 4 - every day/almost every day. For the 31 items, the final score ranges from 0 to 124, for which a higher score will indicate a greater degree of the impact of oral conditions on quality of life of the child. (Jokovic et al., 2003, Peruvian Spanish version 2013) [it will be measured before treatment, one week, one month and 3 months after treatment] Participant and parental/guardian direct visual perception of the lesions will be measured using the Extended Visual Rating Scale for Appearance Match (EVRSAM) Rating Scale. (Ostervemb 2011) [Before, immediately after treatment and 1 and 3 months later] Digital photographic images will be taken under standardised camera and lighting settings. These images will be inspected and rated by a panel consisting of four dentists (two specialist paediatric dentists with experience in MIH (including the student researcher), one general dentist with experience in MIH, one paediatric postgraduate student in training (with limited experience in MIH) and one layperson with no dental training or MIH experience. The examiners, blinded regarding the timepoint at which the image was taken and whether the teeth were bleached before resin infiltration, will grade aesthetic appearance according to EVRSAM. The three images of the treated tooth will be displayed side-by-side in a single Powerpoint® (Microsoft Inc., WA, USA) slide, in randomised order, under standardised lighting and screen brightness settings. Tooth images will be graded using the

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