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

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02969538
• Other study ID #: UFSantaMaria1
• Status: Not yet recruiting
• Phase: N/A
• First received: April 4, 2016
• Last updated: November 16, 2016
• Start date: November 2016
• Est. completion date: November 2017

Study information

• Verified date: November 2016
• Source: Universidade Federal de Santa Maria
• Contact: Rachel Rocha, PhD
• Phone: *55 5532209266
• Email: rachelrocha[@]smail.ufsm.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: November 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 10 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Caries

Intervention

Other:
• Total etching time
Apply 35% phosphoric acid on dentin and enamel by 15 seconds.
• Half-reduced etching time
Apply 35% phosphoric acid on enamel by 15 seconds and dentin by 7 seconds.

Locations

Country	Name	City	State
Brazil	Federal University of Santa Maria	Santa Maria	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Santa Maria

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Failure of restorations		18 months after restorations' placement	No