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

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.

Study Overview

• Status: Unknown
• Conditions: Dental Caries
• Intervention / Treatment: Other: Total etching time; Other: Half-reduced etching time

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: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rachel Rocha, PhD; Phone Number: *55 5532209266; Email: rachelrocha@smail.ufsm.br

Study Locations

• Brazil
  • Rio Grande do Sul
    • Santa Maria, Rio Grande do Sul, Brazil, 97015372
      • Federal University of Santa Maria
      • Contact: Tathiane Lenzi, PhD; Phone Number: +55 55 3220 9266; Email: tathilenzi@usp.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: (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 Names: (dental conditioner - 35% phosphoric acid)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Failure of restorations	18 months after restorations' placement

Collaborators and Investigators

• Sponsor: Universidade Federal de Santa Maria

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Anticipated): May 1, 2017
• Study Completion (Anticipated): November 1, 2017

Study Registration Dates

• First Submitted: April 4, 2016
• First Submitted That Met QC Criteria: November 16, 2016
• First Posted (Estimate): November 21, 2016

Study Record Updates

• Last Update Posted (Estimate): November 21, 2016
• Last Update Submitted That Met QC Criteria: November 16, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: UFSantaMaria1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED