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

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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

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.

Condition or disease Intervention/treatment Phase
Dental Caries Other: Total etching time Other: Half-reduced etching time Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Shortening the Etching Time on the Clinical Performance of Resin Composite Restorations in Primary Teeth
Study Start Date : November 2016
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arm Intervention/treatment
Total etching time
Dentin etching (35% phosphoric acid) by time recommend by manufacturer (15 seconds)
Other: Total etching time
Apply 35% phosphoric acid on dentin and enamel by 15 seconds.
Other Name: (dental conditioner - 35% phosphoric acid)

Experimental: Half-reduced etching time
Dentin etching (35% phosphoric acid) by 7 seconds
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)




Primary Outcome Measures :
  1. Failure of restorations [ Time Frame: 18 months after restorations' placement ]


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02969538


Contacts
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Contact: Rachel Rocha, PhD *55 5532209266 rachelrocha@smail.ufsm.br

Locations
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Brazil
Federal University of Santa Maria Recruiting
Santa Maria, Rio Grande do Sul, Brazil, 97015372
Contact: Tathiane Lenzi, PhD    +55 55 3220 9266    tathilenzi@usp.br   
Sponsors and Collaborators
Universidade Federal de Santa Maria

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Responsible Party: Tathiane Lenzi, Principal investigator, Universidade Federal de Santa Maria
ClinicalTrials.gov Identifier: NCT02969538     History of Changes
Other Study ID Numbers: UFSantaMaria1
First Posted: November 21, 2016    Key Record Dates
Last Update Posted: November 21, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases