Sealants in Molars Affected by Molar-Incisor Hypomineralization

NCT ID: NCT02794116

Last Updated: 2016-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2016-01-31

Brief 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.

Conditions

Molar Incisor Hypomineralization

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group: Sound teeth

20 first permanent molars sound, that not affected by MIH will be included.

The teeth were treated with conventional sealants to prevent caries lesion

Group Type: ACTIVE_COMPARATOR

Conventional Sealants

Intervention Type: PROCEDURE

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.

Test: Hypomineralized teeth

20 first permanent molars affected by MIH will be included.

The MIH teeth were treated with a resin sealants.

Group Type: EXPERIMENTAL

Resin Sealants

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

Control group; Test group

Eligibility Criteria

Exclusion Criteria

• It was excluded teeth with enamel breakdown, enamel tooth malformation linked to syndromes, dental fluorosis, amelogenesis imperfect, fixed orthodontic appliances and patients with bruxism.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Federal do Paraná

OTHER

Sponsor Role: lead

Responsible Party

Juliana Feltrin de Souza Caparroz

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

UFParana_1

Identifier Type: -

Identifier Source: org_study_id