Sealants in Molars Affected by Molar-Incisor Hypomineralization

Molar Incisor Hypomineralization Clinical Trial

Official title:

Survival of Sealants in Molars Affected by Molar-Incisor Hypomineralization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02794116
• Other study ID #: UFParana_1
• Status: Completed
• Phase: N/A
• First received: May 2, 2016
• Last updated: June 7, 2016
• Start date: January 2012
• Est. completion date: January 2016

Study information

• Verified date: June 2016
• Source: Universidade Federal do Paraná
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: January 2016
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 10 Years

Eligibility

Inclusion Criteria:

• The inclusion criteria were children born and living in Araraquara/SP (Brazil), 6 to 8-year-aged, presenting FPM with MIH or sound, fully erupted, with sealant treatment indication.

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Enamel Hypoplasia
• Molar Incisor Hypomineralization

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Paraná

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical Survival of the sealants	The sealants were assessed using the according to the United States Public Health Service-Modified criteria, which the data were analyzed in scores	6 months	Yes
Primary	clinical survival of the sealants	The sealants were assessed using the according to the United States Public Health Service-Modified criteria, which the data were analyzed in scores	18 months	Yes