Clinical trial NCT04195386: Efficacy of a Chemically Activated Composite Resin Alkasite in Atypical Caries Lesions of Deciduous Teeth
Official title: Efficacy of a Chemically Activated Composite Resin Alkasite in Atypical Caries Lesions of Deciduous Teeth - Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries in Children
Keywords: Dental caries
Deciduous teeth
Permanent dental restoration
Lead sponsor: Faculty Sao Leopoldo Mandic Campinas
Sponsor class: OTHER
First posted: 2019-12-11
Enrollment: 108
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Compare the survival of restorations performed with chemically activated composite resin alkasite and resin- modified glass ionomer cement.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Survival of restoration
timeFrame: 12 months after treatment.
Secondary outcomes:
measure: Caries lesion progression
timeFrame: 12 months after treatment.
measure: Secondary caries lesion or on the surface adjacent to the restored tooth
timeFrame: 12 months after treatment.
measure: Perception of children and parents/guardians
timeFrame: 6 months after treatment.
measure: Operator perception
timeFrame: 6 months after the restoration.
measure: Parents/Guardians Satisfaction
timeFrame: 6 months after restoration.
measure: Child discomfort
timeFrame: Immediately after the treatment.
measure: Post Operative sensitivity of the child
timeFrame: 7 ° day after the restorative procedure.
measure: Oral health-related quality of life
timeFrame: 6 month of restorative treatment.
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Faculdade Sao Leopoldo Mandic
state: SP
Study officials:
References: