Clinical trial NCT04685889: Resin Infiltration Treatment for MIH
Official title: Clinical Evaluation of the Effect of Resin Infiltration Treatment on Hypomineralised Enamel Surfaces
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Molar Incisor Hypomineralization
Enamel Hypoplasia
Enamel Caries
Anterior Teeth
Keywords: molar incisor hypomineralisation
resin infiltration
discoloration
enamel
lesion
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2020-12-28
Enrollment: 34
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators aimed to evaluate changes in mineralisation degree, colour, and size of the lesion after Icon® in permanent teeth with MIH in 6 months.

Detailed description: A total of 116 permanent central teeth of 37 patients were included in the study. Icon® was applied to teeth with MIH, while the healthy teeth received no treatment (control).

Group I : Icon® resin infiltration treatment was performed on 58 permanent central teeth with MIH and evaluated before; immediately after; and 1, 3, and 6 months after the procedure.

Group II (Control Group): No treatment was performed on healthy teeth. However, similar to the treated teeth, 58 healthy permanent central teeth of the same individuals were evaluated before; immediately after; and 1, 3, and 6 months after the procedure.

Lesions were evaluated before, immediately after, and 1, 3, and 6 months after treatment. Mineralisation degree of MIH lesions was evaluated using DIAGNOdent Pen, changes in the lesion colour and lesion size were evaluated using VITA EasyShade and the cross polarization technique, respectively.

Eligibility criteria: Inclusion Criteria:

* Molar incisor hypomineralisation on the labial surface of permanent central teeth Least one of the labial surface of the permanent anterior teeth were affected by MIH.

Exclusion Criteria:

* Dental caries and filling on anterior teeth.
* Dental anomaly on anterior teeth.
* Undergoing orthodontic treatment.
* Periodontal diseases.
* Cognitive and behavioural problems.

Primary outcomes:
measure: Changes in the Mineralisation degree
timeFrame: Baseline (before resin infiltration), immediately after resin infiltration, 1 month later, 3 months later, 6 months later
measure: Changes in the lesion colour
timeFrame: Baseline (before resin infiltration), immediately after resin infiltration, 1 month later, 3 months later, 6 months later
measure: Lesion size evaluated using cross polarization technique
timeFrame: Baseline (before resin infiltration), immediately after resin infiltration, 1 month later, 3 months later, 6 months later
Secondary outcomes:
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Gaziosmanpaşa University
Study officials:
affiliation: Tokat Gaziosmanpaşa University, Faculty of Dentistry, Department of Pediatric Dentistry
name: Halenur Altan, assoc. prof.
role: STUDY_DIRECTOR
affiliation: Tokat Gaziosmanpaşa University, Faculty of Dentistry, Department of Pediatric Dentistry
name: Rabia Erağca Yılmaz, Msc. Dt.
role: PRINCIPAL_INVESTIGATOR
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