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

NCT ID: NCT04195386

Last Updated: 2019-12-11

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2021-01-30

Brief Summary

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Atypical cavities, which involve more than two surfaces being one of them vestibular or lingual/palatine, are a challenge for restorative dentistry, since the risk of failure of the restorations are related to the number of surfaces involved. Thus, the objective of this project is to conduct a randomized clinical trial in order to evaluate the efficacy and patient-centered outcomes of a chemically-activated alkasite composite resin in atypical lesions of deciduous molars. Deciduous molars of children between 4 and 7 years of age with at least one atypical cavity lesion in deciduous molars will be selected for the ECR. The selected teeth will be randomly divided into two groups: Chemically activated composite resin Alkasite and resin-Modified glass ionomer cement. Clinical and radiographic follow-up of the lesions will be performed for 6 and 12 months. The efficacy of the treatments will be evaluated by the longevity of the restoring procedures and the arrestment of the caries lesions. Patient-centered outcomes will also be evaluated.

Detailed Description

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Conditions

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Dental Caries in Children

Keywords

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Dental caries Deciduous teeth Permanent dental restoration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Compare the survival of restorations performed with chemically activated composite resin alkasite and resin- modified glass ionomer cement.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Chemically activated Composite resin Alkasite

Single placement of composite resin on atypical cavities.

Group Type EXPERIMENTAL

Dental Restoration with Chemically activated Composite resin Alkasite

Intervention Type PROCEDURE

Selective removal of dental caries with manual instruments, under relative isolation, application of universal adhesive system and restoration with chemically activated composite resin Alkasite.

Resin-Modified Glass ionomer Cement

Single placement of Resin-Modified Glass ionomer Cement on atypical cavities.

Group Type ACTIVE_COMPARATOR

Dental Restoration with Resin-Modified Glass ionomer Cement

Intervention Type PROCEDURE

Selective removal of dental caries with manual instruments, under relative isolation, application of polyacrylic acid and restoration with resin-modified glass ionomer cement.

Interventions

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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.

Intervention Type PROCEDURE

Dental Restoration with Resin-Modified Glass ionomer Cement

Selective removal of dental caries with manual instruments, under relative isolation, application of polyacrylic acid and restoration with resin-modified glass ionomer cement.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

4 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Faculty Sao Leopoldo Mandic Campinas

OTHER

Sponsor Role lead

Responsible Party

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Jose Carlos P Imparato

PhD in Pediatric Dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculdade Sao Leopoldo Mandic

Campinas, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Facility Contacts

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Jose P Imparato, PhD

Role: primary

Other Identifiers

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SLM2990

Identifier Type: -

Identifier Source: org_study_id