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Can removing proteins before Resin Infiltration improve the appearance of white spots in front teeth affected by MIH? A randomized clinical trial

Influence of Deproteinization as a pre-treatment for Resin Infiltration on the masking of opacities in anterior teeth affected by MIH: a randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8sd4fw4
Enrollment
116
Registered
2026-04-09
Start date
2026-02-21
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

molar hypomineralization Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Interventions

This is a two-arm, randomized, double-blind controlled clinical trial. Participants will be randomly allocated into two groups based on the assessment of anterior teeth. Demarcated opacities (white-cr
therefore, the infiltration pattern will vary for each tooth. Once the desired masking effect is achieved, the application time will be recorded for subsequent analysis, followed by light curing for 4

Sponsors

Universidade de São Paulo
Lead Sponsor
Universidade de São Paulo
Collaborator

Eligibility

Age
6 Years to 14 Years

Inclusion criteria

Inclusion criteria: Individuals aged between 6 and 14 years who present at least one permanent incisor with molar-incisor hypomineralization opacities of white-cream and yellow-brown coloration.

Exclusion criteria

Exclusion criteria: amelogenesis imperfecta; tetracycline staining; hypoplasia; fixed orthodontic appliances; previous restorations; dental caries; opacities restricted only to anterior teeth; teeth with post-eruptive fracture; patients whose parents do not allow participation

Design outcomes

Primary

MeasureTime frame
Quantitative color change assessment will be performed using a spectrophotometer (EasyShade, Vita Zahnfabrik), according to the CIE Lab color system (Commission Internationale de l’Eclairage). The L parameter corresponds to lightness (0 = black and 100 = white), while a* and b* represent the red–green and yellow–blue axes, respectively. Color variation (?E) will be evaluated in both the opacity and the sound enamel area before and after treatment, as well as at follow-up periods (1 month, 3 months, and 6 months). A reference ?E value of 3.7 will be adopted, as this threshold is considered clinically acceptable (Hoan et al., 2024). Therefore, ?E values lower than 3.7 will indicate that the lesions achieved a masking effect, whereas values greater than 3.7 will indicate no change in opacity.

Secondary

MeasureTime frame
Qualitative color change analysis will be performed using paired assessment. Baseline and follow-up photographs will be arranged side by side in Microsoft PowerPoint. Two experienced, blinded examiners will independently evaluate the images and classify the treatment outcome as: (1) complete masking (the opacity is no longer perceptible), (2) partial masking (the opacity has decreased or approximated the tooth color but remains perceptible), and (3) no masking (no change in the color or size of the opacity).

Countries

BR

Contacts

Public ContactAna Boteon

Faculdade de Odontologia de Bauru - Universidade de São Paulo

anapboteon@gmail.com+55 (14) 32358000

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: May 1, 2026