MedDataX Logo

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

NCT ID: NCT02969538

Last Updated: 2016-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dental Caries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Total etching time

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

Group Type OTHER

Total etching time

Intervention Type OTHER

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

Half-reduced etching time

Dentin etching (35% phosphoric acid) by 7 seconds

Group Type EXPERIMENTAL

Half-reduced etching time

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Total etching time

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

Intervention Type OTHER

Half-reduced etching time

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

(dental conditioner - 35% phosphoric acid) (dental conditioner - 35% phosphoric acid)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidade Federal de Santa Maria

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Tathiane Lenzi

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Federal University of Santa Maria

Santa Maria, Rio Grande do Sul, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Rachel Rocha, PhD

Role: CONTACT

Phone: *55 5532209266

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Tathiane Lenzi, PhD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UFSantaMaria1

Identifier Type: -

Identifier Source: org_study_id