Clinical trial NCT04195022: Comparison of a Chemically Activated Composite Resin Alkasite With Resin Composite in Atypical Caries Lesions of Deciduous Teeth
Official title: Comparison of a Chemically Activated Composite Resin Alkasite With Resin Composite in Atypical Caries Lesions of Deciduous Teeth - A Non-inferiority 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: 162
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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 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.

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 treatment.
measure: Parents/Guardians Satisfaction
timeFrame: 6 months after treatment.
measure: Child discomfort
timeFrame: Immediately after the treatment.
measure: Post Operative sensitivity of the child
timeFrame: 7 days after treatment.
measure: Oral health-related quality of life
timeFrame: 6 months after treatment.
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Faculty Sao Leopoldo Mandic
state: Sao Paulo
Study officials:
References: