Sealants in Molars Affected by Molar-Incisor Hypomineralization

NCT02794116 | Completed DMC

• 1 other identifier: UFParana_1
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Molar Incisor Hypomineralization

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Control group: Sound teeth

ACTIVE COMPARATOR

20 first permanent molars sound, that not affected by MIH will be included. The teeth were treated with conventional sealants to prevent caries lesion

Procedure: Conventional Sealants

Test: Hypomineralized teeth

EXPERIMENTAL

20 first permanent molars affected by MIH will be included. The MIH teeth were treated with a resin sealants.

Procedure: Resin Sealants

Interventions

Conventional Sealants 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.

Also known as: Control group

Control group: Sound teeth

Resin Sealants 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.

Also known as: Test group

Test: Hypomineralized teeth

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Federal do Paraná: lead

MeSH Terms

Conditions

Molar Hypomineralization

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 2, 2016
• First Posted: June 8, 2016
• Study Start: January 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2016
• Last Updated: June 8, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will share