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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02969538

Enrollment

Registered

2016-11-21

Start date

2016-11-30

Completion date

2017-11-30

Last updated

2016-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries

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.

Interventions

OTHERTotal etching time

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

OTHERHalf-reduced etching time

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

5 Years to 10 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Failure of restorations	18 months after restorations' placement

Countries

Brazil

Contacts

Primary ContactRachel Rocha, PhD

rachelrocha@smail.ufsm.br*55 5532209266

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026