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Sealants in Molars Affected by Molar-Incisor Hypomineralization

NCT02794116 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2016-06-08

No results posted yet for this study

Summary

Aim: To evaluate the clinical survival of fluoride sealants applied in first permanent molars affected by Molar-Incisor Hypomineralization (MIH).

Material and Methods: For this case control study, it was selected 41 first permanent molars of the 21 children aged 6-8 years. MIH was classified by one calibrated examiner (kappa 0.80) according severity of the MIH lesion (EAPD, 2003). Inclusion criteria were FPM with MIH or sound (without MIH), fully erupted, and with sealant treatment indication.

The FPMs were assigned into two groups: G1 - Control group and G2 - MIH group. Both group teeth were treated with sealant application (Fluroshield, NY, USA). Clinical follow-up was performed at baseline, 1, 6, 12 and 18 months for anatomic form, marginal adaptation, retention and presence of caries, according to the United States Public Health Service USPHS-Modified by a blinded examiner (kappa 0.80). The Acturial Method was used to evaluate the survival of sealants. Statistical analysis compared the ratings of each criterion between materials using the Fisher's exact test at a level of significance of 5% (p\<0.05).

Conditions

  • Molar Incisor Hypomineralization

Interventions

PROCEDURE

Conventional Sealants

It is a preventive treatment for caries lesions. The procedure following operative sequence: prophylaxis; absolute isolation; application of 37.5% phosphoric acid for 30 s in enamel; extensive washing; drying with cotton and air jet for 5 s; sealing with resin sealant application (Fluroshield, NY, USA), according to manufacturer guidelines; removal absolute isolation; examination of occlusal contact and final polishing.

PROCEDURE

Resin Sealants

It is a resin sealants to preventive treatment for caries lesions. The procedure following operative sequence: prophylaxis; absolute isolation; application of 37.5% phosphoric acid for 30 s in enamel; extensive washing; drying with cotton and air jet for 5 s; sealing with resin sealant application (Fluroshield, NY, USA), according to manufacturer guidelines; removal absolute isolation; examination of occlusal contact and final polishing.

Sponsors & Collaborators

  • Universidade Federal do Paraná

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-01-31
Completion
2016-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02794116 on ClinicalTrials.gov