Effect of Shortening the Etching Time on the Clinical Performance of Resin Composite Restorations in Primary Teeth
Primary Purpose
Dental Caries
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Total etching time
Half-reduced etching time
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries
Eligibility 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.
Sites / Locations
- Federal University of Santa Maria
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Total etching time
Half-reduced etching time
Arm Description
Dentin etching (35% phosphoric acid) by time recommend by manufacturer (15 seconds)
Dentin etching (35% phosphoric acid) by 7 seconds
Outcomes
Primary Outcome Measures
Failure of restorations
Secondary Outcome Measures
Full Information
NCT ID
NCT02969538
First Posted
April 4, 2016
Last Updated
November 16, 2016
Sponsor
Universidade Federal de Santa Maria
1. Study Identification
Unique Protocol Identification Number
NCT02969538
Brief Title
Effect of Shortening the Etching Time on the Clinical Performance of Resin Composite Restorations in Primary Teeth
Official Title
Effect of Shortening the Etching Time on the Clinical Performance of Resin Composite Restorations in Primary Teeth
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
November 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Santa Maria
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Total etching time
Arm Type
Other
Arm Description
Dentin etching (35% phosphoric acid) by time recommend by manufacturer (15 seconds)
Arm Title
Half-reduced etching time
Arm Type
Experimental
Arm Description
Dentin etching (35% phosphoric acid) by 7 seconds
Intervention Type
Other
Intervention Name(s)
Total etching time
Other Intervention Name(s)
(dental conditioner - 35% phosphoric acid)
Intervention Description
Apply 35% phosphoric acid on dentin and enamel by 15 seconds.
Intervention Type
Other
Intervention Name(s)
Half-reduced etching time
Other Intervention Name(s)
(dental conditioner - 35% phosphoric acid)
Intervention Description
Apply 35% phosphoric acid on enamel by 15 seconds and dentin by 7 seconds.
Primary Outcome Measure Information:
Title
Failure of restorations
Time Frame
18 months after restorations' placement
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel Rocha, PhD
Phone
*55 5532209266
Email
rachelrocha@smail.ufsm.br
Facility Information:
Facility Name
Federal University of Santa Maria
City
Santa Maria
State/Province
Rio Grande do Sul
ZIP/Postal Code
97015372
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tathiane Lenzi, PhD
Phone
+55 55 3220 9266
Email
tathilenzi@usp.br
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Shortening the Etching Time on the Clinical Performance of Resin Composite Restorations in Primary Teeth
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