Influences of Gingival Cord Retractor in Retention Rate of Non-carious Cervical Lesions Restorations.

November 10, 2016 updated by: PAULO VINICIUS SOARES, Federal University of Uberlandia

Influences of Gingival Cord Retractor in Retention Rate of Non-carious Cervical Lesions Restorations With Different Adhesive Systems. Randomized Clinical Trials.

The aim of this study is through a randomized clinical trial, double blind, splith-mouth, evaluate the retention rate of restorative protocols of Non-carious cervical lesion. The presence of gingival displacement with a retraction cord (yes or no) and the category of adhesive system (etch-and-rise and self-etching) will be evaluated. Data will be collected, tabulated and submitted to statistical analysis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Cervical wear is classified as a noncarious cervical lesion (NCCL), which is a pathological process characterized by loss of dental hard tissues near the cementoenamel junction (CEJ). The aim of this study is through a randomized clinical trial, double blind, splith-mouth, evaluate the retention rate of restorative protocols of Non-carious cervical lesion. The presence of gingival displacement with a retraction cord and the category of adhesive system will be evaluated. Two hundred and twenty teeth, with NCCL of depth greater than 1.5mm, of 55 healthy patients of both sexes will be select. The teeth will be randomly divided into 4 different groups according to the gingival displacement with retraction cord (yes or no) and adhesive system category (etch-and-rise and self-etching). Data will be collected, tabulated and submitted to statistical analysis.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
55

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Brazil
    • Minas Gerais
      • Uberlandia, Minas Gerais, Brazil, 381440617

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy volunteers; both genres; presence of at least four non carious cervical lesions of similar dimensions in the same arc and opposite quadrants; good oral hygiene.

Exclusion Criteria:

  • Presence of cavities, cracks or enamel fractures; extensive or unsatisfactory restorations; recent restorations involving the labial surface; dentures or orthodontics; presence of periodontal disease and,or parafunctional habits; systemic disease and, or severe psychological; constant use of analgesic and, or anti-inflammatory or allergic response to dental products.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Retraction and total-etch
Gingival displacement with a gingival cord (#0, #00 or #000) prior to the restoration. Application of total-etch adhesive system: enamel and dentin etched with 35% phosphoric acid, wash, dry, two layers of primer/bond application with a brush and photoactivated for 20 seconds.
Procedure: Gingival displacement
Gingival displacement with a gingival cord (#0, #00 or #000) with specific spatula.
Procedure: Enamel and dentin etched
Enamel and dentin etched with 35% phosphoric acid for 30 and 15 seconds, respectively.
Procedure: Wash and dry
Wash and dry with absorbent paper.
Device: Total-etch adhesive system
Two layers of pirmer/bond on enamel and dentin with a brush.
Procedure: Photoactivated
Photoactivated for 20 seconds
Active Comparator: No retraction and total-etch
Application of total-etch adhesive system: enamel and dentin etched with 35% phosphoric acid, wash, dry, two layers of primer/bond application with a brush and photoactivated for 20 seconds.
Procedure: Enamel and dentin etched
Enamel and dentin etched with 35% phosphoric acid for 30 and 15 seconds, respectively.
Procedure: Wash and dry
Wash and dry with absorbent paper.
Device: Total-etch adhesive system
Two layers of pirmer/bond on enamel and dentin with a brush.
Procedure: Photoactivated
Photoactivated for 20 seconds
Active Comparator: Retraction and self-conditioning
Gingival displacement with a gingival cord (#0, #00 or #000) prior to the restoration. Application of self-conditioning adhesive system: selective enamel etched with 35% phosphoric acid, wash, dry, one layer of acid/pirmer on enamel and dentin with a brush, one layer of bond with a brush and photoactivated for 20 seconds.
Procedure: Gingival displacement
Gingival displacement with a gingival cord (#0, #00 or #000) with specific spatula.
Procedure: Wash and dry
Wash and dry with absorbent paper.
Procedure: Photoactivated
Photoactivated for 20 seconds
Procedure: Selective enamel etched
Selective enamel etched with 35% phosphoric acid for 15 seconds.
Device: self-conditioning adhesive system
One layer of acid/pirmer on enamel and dentin with a brush following to one layer of bond with a brush.
Active Comparator: No retraction and self-conditioning
Application of self-conditioning adhesive system: selective enamel etched with 35% phosphoric acid, wash, dry, one layer of acid/pirmer on enamel and dentin with a brush, one layer of bond with a brush and photoactivated for 20 seconds.
Procedure: Wash and dry
Wash and dry with absorbent paper.
Procedure: Photoactivated
Photoactivated for 20 seconds
Procedure: Selective enamel etched
Selective enamel etched with 35% phosphoric acid for 15 seconds.
Device: self-conditioning adhesive system
One layer of acid/pirmer on enamel and dentin with a brush following to one layer of bond with a brush.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Success rate of noncarious cervical lesions restorations according to the World Dental Federation criterion
Time Frame: 36 mounths
Evaluate the success rate of NCCL restoration with a 36 mounths follow up
36 mounths

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federal University of Uberlandia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 8, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 10, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 11, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CAAE - 57032016.0.0000.5152

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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