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Restorative Treatment in First Molars Affected by Molar-Incisor Hypomineralization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02717286
Recruitment Status : Completed
First Posted : March 23, 2016
Last Update Posted : March 30, 2016
Sponsor:
Information provided by (Responsible Party):
Juliana Feltrin de Souza Caparroz, Universidade Federal do Paraná

Tracking Information
First Submitted Date  ICMJE March 18, 2016
First Posted Date  ICMJE March 23, 2016
Last Update Posted Date March 30, 2016
Study Start Date  ICMJE January 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2016)
Survival rates of the direct restorative treatment [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Restorative Treatment in First Molars Affected by Molar-Incisor Hypomineralization
Official Title  ICMJE Survival of Restorative Treatment in First Molars Affected by Molar-Incisor Hypomineralization
Brief Summary The restorative management of molars with Molar-Incisor Hypomineralization (MIH) represents a challenge in the clinical practice with high failure rate. Thus, this clinical trial aimed to evaluate the clinical survival of direct composite resin restorations in first permanent molars (FPMs) that are affected by MIH, comparing two adhesive systems.
Detailed Description For the research, it was selected first permanent molars (FPMs) with MIH from children aged 6-8 years. FPM fully erupted and with restorative treatment needed was the inclusion criteria. We excluded FPMs with destroyed crowns. The FPMs were randomly assigned to two groups: G1 (self-etching adhesive) and G2 (total-etching adhesive). Clinical evaluation was performed during 18 months according to the USPHS-Modified by a blinded examiner. The actuarial method was used to evaluate survival of the restorations and Fisher's exact test was used to compare differences between the groups (α=5%).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Molar Incisor Hypomineralization
Intervention  ICMJE Procedure: restorative
It was performed direct restoration using two kinds of adhesive system (total-etching adhesive and self-etching adhesive)
Study Arms  ICMJE
  • Sham Comparator: Control

    20 first permanent molars from children aged between 6 to 12 years old presenting MIH will be included. A calibrated pediatric dentist examined the selected teeth to classify MIH according to the European Academy of Pediatric Dentistry (EADP) criteria.

    Intervention of Control: The restorative treatment using a total-etching adhesive system, which was performed according to the following operative sequence: prophylaxis, infiltrative anesthesia, rubber dam, application of 37.5% phosphoric acid to enamel (30 s) and dentine (15 s), extensive washing, drying with cotton and air jet (5 s), priming (5 s), light curing (20 s), restoration with composite resin (Filtek XT350), examination of occlusal contact, and final polishing.

    Intervention: Procedure: restorative
  • Experimental: Test

    20 first permanent molars from children aged between 6 to 12 years old presenting Molar Incisor Hypomineralization will be included. A calibrated pediatric dentist examined the selected teeth to classify MIH according to the EAPD criteria.

    Intervention of test: the restorative treatment using a self-etching adhesive system, which was performed according to the following operative sequence: prophylaxis, infiltrative anesthesia, rubber dam, application of 37.5% phosphoric acid to enamel (30 s) and dentine (15 s), extensive washing, drying with cotton and air jet (5 s), priming (5 s), air jet (5 s), adhesive application (5 s), light curing (20 s), restoration with composite resin (Filtek XT350), examination of occlusal contact, and final polishing.

    Intervention: Procedure: restorative
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 18, 2016)
26
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • children and/or parents who agree in participate of the study
  • children were born and living in Araraquara, SP, Brazil
  • presence of the first permanent molars totally erupted with defects classified as enamel post eruptive breakdown (PEB) or unsatisfactory atypical restoration (UATR), with or without carious lesions.

Exclusion Criteria:

  • children and/or parents who do not agree in participate of the study
  • first permanent molars with enamel malformation associated with syndromes,
  • dental fluorosis,
  • first permanent molars with destroyed crowns,
  • imperfect amelogenesis
  • fixed orthodontic appliances.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 8 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02717286
Other Study ID Numbers  ICMJE UFParana
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Juliana Feltrin de Souza Caparroz, Universidade Federal do Paraná
Study Sponsor  ICMJE Universidade Federal do Paraná
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Rita de Cássia Loiola Cordeiro, PhD UNESP- Univ Estadual Paulista
PRS Account Universidade Federal do Paraná
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP