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

NCT ID: NCT04195022

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

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2020-01-30

Brief Summary

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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.

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

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.

Bulk fill resin composite

Single placement of Bulk fill resin composite on atypical cavities.

Group Type ACTIVE_COMPARATOR

Dental Restoration with Bulk fill resin composite

Intervention Type PROCEDURE

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

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 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.

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 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.
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

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty Sao Leopoldo Mandic

Campinas, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Facility Contacts

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Jose Carlos P Imparato, PhD

Role: primary

Other Identifiers

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SLM2990II

Identifier Type: -

Identifier Source: org_study_id