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Effect of Shortening the Etching Time on the Clinical Performance of Resin Composite Restorations in Primary Teeth

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: NCT02969538
Recruitment Status : Unknown
Verified November 2016 by Tathiane Lenzi, Universidade Federal de Santa Maria.
Recruitment status was:  Not yet recruiting
First Posted : November 21, 2016
Last Update Posted : November 21, 2016
Sponsor:
Information provided by (Responsible Party):
Tathiane Lenzi, Universidade Federal de Santa Maria

Tracking Information
First Submitted Date  ICMJE April 4, 2016
First Posted Date  ICMJE November 21, 2016
Last Update Posted Date November 21, 2016
Study Start Date  ICMJE November 2016
Estimated Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2016)
Failure of restorations [ Time Frame: 18 months after restorations' placement ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
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 Effect of Shortening the Etching Time on the Clinical Performance of Resin Composite Restorations in Primary Teeth
Official Title  ICMJE Effect of Shortening the Etching Time on the Clinical Performance of Resin Composite Restorations in Primary Teeth
Brief Summary The aim of this study is to evaluate the effect of shortening the etching time on the 18-month clinical performance of resin composite restorations in primary molars after partial carious removal. This randomized clinical trial will include subjects (5-10 year-old children) selected at Pediatric Clinic of Federal University of Santa Maria. The sample will consist of 70 primary molars presenting active cavitated carious lesions (with radiographic involvement of the outer half of the dentin), located on the occlusal surface. The sample will be randomly divided into two groups according to the etching time of the dentin prior adhesive application (Adper Single Bond 2; 3M ESPE): recommend by manufacturers (15 seconds) and half-reduced etching time (7 seconds). The restorations will be clinically followed every 6 months for up to 18-month using the FDI criteria for clinical evaluation. Survival estimates for restoration longevity will be evaluated using the Kaplan-Meier method.
Detailed Description The aim of this study is to evaluate the effect of shortening the etching time on the 18-month clinical performance of resin composite restorations in primary molars after partial carious removal. This randomized clinical trial will include subjects (5-10 year-old children) selected at Pediatric Clinic of Federal University of Santa Maria. The sample will consist of 70 primary molars presenting active cavitated carious lesions (with radiographic involvement of the outer half of the dentin), located on the occlusal surface. The sample will be randomly divided into two groups according to the etching time of the dentin prior adhesive application (Adper Single Bond 2; 3M ESPE): applying of 35% phosphoric acid by 15 s - recommend by manufacturers and half-reduced etching time (7 s). The restorations will be clinically followed every 6 months for up to 18-month using the FDI criteria for clinical evaluation. Survival estimates for restoration longevity will be evaluated using the Kaplan-Meier method.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dental Caries
Intervention  ICMJE
  • Other: Total etching time
    Apply 35% phosphoric acid on dentin and enamel by 15 seconds.
    Other Name: (dental conditioner - 35% phosphoric acid)
  • Other: Half-reduced etching time
    Apply 35% phosphoric acid on enamel by 15 seconds and dentin by 7 seconds.
    Other Name: (dental conditioner - 35% phosphoric acid)
Study Arms  ICMJE
  • Total etching time
    Dentin etching (35% phosphoric acid) by time recommend by manufacturer (15 seconds)
    Intervention: Other: Total etching time
  • Experimental: Half-reduced etching time
    Dentin etching (35% phosphoric acid) by 7 seconds
    Intervention: Other: Half-reduced etching time
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 16, 2016)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2017
Estimated Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

*Active carious lesion in middle dentin limited to the occlusal surfaces of primary molars.

Exclusion Criteria:

  • Children who refuse or fail to cooperate with the completion of clinical procedure;
  • Teeth without antagonist;
  • Carious lesions in inner half of dentin;
  • Presence of painful symptoms or signs of pulpal changes.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 10 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 NCT02969538
Other Study ID Numbers  ICMJE UFSantaMaria1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Tathiane Lenzi, Universidade Federal de Santa Maria
Study Sponsor  ICMJE Universidade Federal de Santa Maria
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Universidade Federal de Santa Maria
Verification Date November 2016

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