Sealants in Molars Affected by Molar-Incisor Hypomineralization
Condition: Molar Incisor Hypomineralization
MeSH terms: Molar Hypomineralization; Dental Enamel Hypoplasia
Study type: Interventional

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).
    

Detailed description: 
      This study was conducted according to the Helsink Declaration. The approval was obtained from
      the Ethics and Research Committee at Araraquara Dental School, São Paulo, Brazil (protocol
      #11/09). All parents/guardians of the children signed the informed consent.

      Study design:

      This case control study included four clinical exams performed in 6 to 8 years-old children
      that received preventive treated with sealants, divided into 2 groups: G1 - teeth not affect
      by MIH and G2 - teeth affect by MIH.

      Subjects:

      The 21 children included in the study had been previously diagnosed with MIH, according to
      the EAPD criteria. A total of 41 first permanent molars teeth (FPM) were included, being 16
      without MIH and 25 with MIH.

      Calibration of the examiner for the evaluations:

      The examiner was calibrated according to MIH based on criteria proposed by the European
      Academy of Pediatric Dentistry and for USPHS-Modified. The examiner assessed 32 clinical
      photographs of patients from the Clinic of Pediatric Dentistry of the Araraquara Dental
      School in São Paulo, Brazil, followed by a discussion with the MIH research team of all the
      indices and codes. After an agreement, 30 patients with enamel alterations (17 of them with
      MIH) were evaluated. After 2 weeks, the patients were reevaluated and the Kappa coefficient
      was used to verify the agreement between the evaluations. The intra-examiner values for MIH
      and USPHS-modified were 0.80.

      Treatment:

      The 41 FMP were clinically examined and classified according the presence of MIH according
      the European Association of Paediatric Dentistry and were distributed into groups. The
      preventive procedures were performed at the Pedodontics Clinics of São Paulo State
      University, for another operator. All teeth receive pre-treat with care 4 weekly applications
      of fluoride varnish (Duraphat, NY, USA).

      Both group teeth were treated with sealants.

      Evaluation:

      The four clinical exams (1, 6, 12 and 18 months) were performed in a clinical environment
      according exams preconized by the World Health Organization under artificial lights and after
      prophylaxis.

      The sealants were clinically evaluated by a calibrated examiner (Kappa 0.80). The groups were
      evaluated according to the criteria for quality of the restoration proposed by the United
      States Public Health Service USPHS-Modified and classified as satisfactory or unsatisfactory.
      When the tooth was considered unsatisfactory, it was considered failure and the treatment was
      replaced but it had not considered for the research evaluations.
    

Intervention name(s): Conventional Sealants; Resin Sealants
Intervention type(s): Procedure; Procedure
Intervention description(s): 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.; 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.
Other intervention name(s): Control group; Test group
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment