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
About this trial
This is an interventional treatment trial for Molar Incisor Hypomineralization
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.
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
NCT ID
NCT02794116
First Posted
May 2, 2016
Last Updated
June 7, 2016
Sponsor
Universidade Federal do Paraná
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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