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

NCT02969538 | Unknown DMC

• 1 other identifier: UFSantaMaria1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

• Failure of restorations

  18 months after restorations' placement

Study Arms (2)

Total etching time

OTHER

Dentin etching (35% phosphoric acid) by time recommend by manufacturer (15 seconds)

Other: Total etching time

Half-reduced etching time

EXPERIMENTAL

Dentin etching (35% phosphoric acid) by 7 seconds

Other: Half-reduced etching time

Interventions

Total etching time OTHER

Apply 35% phosphoric acid on dentin and enamel by 15 seconds.

Also known as: (dental conditioner - 35% phosphoric acid)

Total etching time

Half-reduced etching time OTHER

Apply 35% phosphoric acid on enamel by 15 seconds and dentin by 7 seconds.

Also known as: (dental conditioner - 35% phosphoric acid)

Half-reduced etching time

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Santa Maria: lead

Study Sites (1)

Federal University of Santa Maria

Santa Maria, Rio Grande do Sul, 97015372, Brazil

Location

MeSH Terms

Conditions

Dental Caries

Interventions

phosphoric acid

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Rachel Rocha, PhD

CONTACT

*55 5532209266; rachelrocha@smail.ufsm.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 4, 2016
• First Posted: November 21, 2016
• Study Start: November 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: November 1, 2017
• Last Updated: November 21, 2016

Record last verified: 2016-11

Locations

BR (1)