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

Faculty Sao Leopoldo Mandic Campinas

Status: Unknown

Conditions: Dental Caries in Children

Treatments: Procedure: Dental Restoration with Chemically activated Composite resin Alkasite; Procedure: Dental Restoration with Resin-Modified Glass ionomer Cement

Study type: Interventional

Funder types: Other

Identifiers

NCT04195386

SLM2990

Details and patient eligibility

About

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.

Enrollment: 108 estimated patients

Sex: All

Ages: 4 to 7 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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108 participants in 2 patient groups

Chemically activated Composite resin Alkasite

Experimental group

Description:

Single placement of composite resin on atypical cavities.

Treatment:

Procedure: Dental Restoration with Chemically activated Composite resin Alkasite

Resin-Modified Glass ionomer Cement

Active Comparator group

Description:

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

Treatment:

Procedure: Dental Restoration with Resin-Modified Glass ionomer Cement