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Sealants in Molars Affected by Molar-Incisor Hypomineralization

Primary Purpose

Molar Incisor Hypomineralization

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Conventional Sealants
Resin Sealants
Sponsored by
Universidade Federal do Paraná
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Molar Incisor Hypomineralization

Eligibility Criteria

6 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Control group: Sound teeth

    Test: Hypomineralized teeth

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    May 2, 2016
    Last Updated
    June 7, 2016
    Sponsor
    Universidade Federal do Paraná
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02794116
    Brief Title
    Sealants in Molars Affected by Molar-Incisor Hypomineralization
    Official Title
    Survival of Sealants in Molars Affected by Molar-Incisor Hypomineralization
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2012 (undefined)
    Primary Completion Date
    January 2013 (Actual)
    Study Completion Date
    January 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade Federal do Paraná

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Molar Incisor Hypomineralization

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Non-Randomized
    Enrollment
    21 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group: Sound teeth
    Arm Type
    Active Comparator
    Arm Description
    20 first permanent molars sound, that not affected by MIH will be included. The teeth were treated with conventional sealants to prevent caries lesion
    Arm Title
    Test: Hypomineralized teeth
    Arm Type
    Experimental
    Arm Description
    20 first permanent molars affected by MIH will be included. The MIH teeth were treated with a resin sealants.
    Intervention Type
    Procedure
    Intervention Name(s)
    Conventional Sealants
    Other Intervention Name(s)
    Control group
    Intervention Description
    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
    Intervention Name(s)
    Resin Sealants
    Other Intervention Name(s)
    Test group
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    clinical Survival of the sealants
    Description
    The sealants were assessed using the according to the United States Public Health Service-Modified criteria, which the data were analyzed in scores
    Time Frame
    6 months
    Title
    clinical survival of the sealants
    Description
    The sealants were assessed using the according to the United States Public Health Service-Modified criteria, which the data were analyzed in scores
    Time Frame
    18 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    10 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

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    Sealants in Molars Affected by Molar-Incisor Hypomineralization

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