Comparison of a Chemically Activated Composite Resin Alkasite With Resin Composite in Atypical Caries Lesions of Deciduous Teeth

December 9, 2019 updated by: Jose Carlos P Imparato, Faculty Sao Leopoldo Mandic Campinas

Comparison of a Chemically Activated Composite Resin Alkasite With Resin Composite in Atypical Caries Lesions of Deciduous Teeth - A Non-inferiority Randomized Clinical Trial

Atypical cavities, which involve more than two surfaces, one being buccal or lingual/palatal, are a challenge for restorative dentistry, since the risk of restorative failure is related to the number of surfaces involved. Thus, the purpose of this umbrella project is to conduct a randomized controlled trial (RCT) to evaluate the efficacy and patient-centered outcomes of a chemically activated composite alkasite resin in atypical deciduous molar lesions. Primary molars of children aged 4 to 7 years with at least one atypical cavitary lesion in primary molars will be selected for the RCT. The selected teeth will be randomly divided into: Alkasite chemically activated composite resin and Bulk fill composite resin. Clinical and radiographic follow-up of the lesions will be performed for 6 and 12 months. The effectiveness of the treatments will be evaluated by the longevity of the restorative procedures and paralysis of the lesions. Patient-centered outcomes will also be evaluated.

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.

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.
162

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 Locations

  • Brazil
    • Sao Paulo
      • Campinas, Sao Paulo, Brazil, 13045755
        • Recruiting
        • Faculty Sao Leopoldo Mandic
        • Contact:
          • Jose Carlos P Imparato, PhD
          • Phone Number: +551935183601
          • Email: jimparato@usp.br
        • Sub-Investigator:
          • Ana Paula M de Araújo
        • Sub-Investigator:
          • Bruno P de Posses
        • Sub-Investigator:
          • Débora S Dionísio
        • Sub-Investigator:
          • Jaqueline M Salviogni
        • Sub-Investigator:
          • Lis T Meneghel
        • Sub-Investigator:
          • Malvina S Pereira
        • Sub-Investigator:
          • Mayra de Jesus
        • Sub-Investigator:
          • Naiara S de Almeida
        • Sub-Investigator:
          • Patrícia S Marzarotto

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

4 years to 7 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children will be included who have at least one posterior tooth with atypical caries lesion.

Exclusion Criteria:

  • Patients with special needs will be excluded, with general health conditions that may affect the oral cavity, non-cooperating in relation to the examination, which use orthodontic apparatus and the parents/guardians or children not to consent to their participation in the study. In addition, teeth with pulp exposure, spontaneous pain, mobility, presence of swelling or fistula close to the tooth, furcation or cervical injury, teeth with restorations, sealants or enamel formation defects will be excluded.

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: Single

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.
Experimental: Chemically activated Composite resin Alkasite
Single placement of composite resin on atypical cavities.
Procedure: Dental Restoration with Chemically activated Composite resin Alkasite
Selective removal of dental caries with manual instruments, under relative isolation, application of universal adhesive system and restoration with chemically activated composite resin Alkasite.
Active Comparator: Bulk fill resin composite
Single placement of Bulk fill resin composite on atypical cavities.
Procedure: Dental Restoration with Bulk fill resin composite
Selective removal of dental caries with manual instruments, under relative isolation, application of universal adhesive system and restoration with bulk fill resin composite.

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
Survival of restoration
Time Frame: 12 months after treatment.
To evaluate the survival of restoration by clinical examination with FDI index.
12 months after treatment.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Caries lesion progression
Time Frame: 12 months after treatment.
For the evaluation of caries progression, the interproximal radiographic examination will be used to verify an increase of radiolucent image under restoration.
12 months after treatment.
Child discomfort
Time Frame: Immediately after the treatment.
The child will also be questioned as to the discomfort in relation to the treatment performed. For this will be used the scale of faces of Wong-Baker.
Immediately after the treatment.
Secondary caries lesion or on the surface adjacent to the restored tooth
Time Frame: 12 months after treatment.
Presence of caries lesion on the surface adjacent to the restored tooth or on the margins of the restoration by means of visual Clinical Examination.
12 months after treatment.
Perception of children and parents/guardians
Time Frame: 6 months after treatment.
To evaluate the satisfaction of the children in relation to the treatment performed. The questionnaire will be used "Child's and parent's questionnaire about teeth appearance".
6 months after treatment.
Operator perception
Time Frame: 6 months after treatment.
It will be employed a questionnaire after the completion of the treatment performed. It will also be added a question about the behavior of children during the procedure, which will be categorized as - great behavior, regular or bad.
6 months after treatment.
Parents/Guardians Satisfaction
Time Frame: 6 months after treatment.
The parents/guardians will be questioned about the satisfaction regarding the treatment performed in the child. The answer will be scored by a likert scale.
6 months after treatment.
Post Operative sensitivity of the child
Time Frame: 7 days after treatment.
The child will also be questioned about the sensitivity of the restorative procedure. For this, the Wong-Baker face scale will be used.
7 days after treatment.
Oral health-related quality of life
Time Frame: 6 months after treatment.
The validated Brazilian version of Early Childhood Oral Health Impact Scale (ECOHIS) will be applied to children and should be answered by their parents.
6 months after treatment.

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.
Faculty Sao Leopoldo Mandic Campinas

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 (Actual)

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.
September 1, 2019

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.
January 30, 2020

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.
January 30, 2020

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).
September 30, 2019

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.
December 9, 2019

First Posted (Actual)

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.
December 11, 2019

Study Record Updates

Last Update Posted (Actual)

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.
December 11, 2019

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.
December 9, 2019

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.
December 1, 2019

More Information

Terms related to this study

Keywords

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.
  • SLM2990II

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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