Clinical trial NCT02903979: Impact of Different Restorative Treatments for Deep Caries Lesion in Primary Teeth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deep Caries Lesion of Primary Teeth
Lead sponsor: Universidade Ibirapuera
Sponsor class: OTHER
First posted: 2016-09-16
Enrollment: 108
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In front of a lack of evidence to determine the best treatment for deep cavitated carious lesions, the search for an effective restorative technique, which results in a least possible discomfort to patients, and reduce the time needed for the restorative treatment, if becomes relevant. The objective of this randomized clinical trial to evaluate the efficacy of high viscosity glass ionomer cement restorations (HVGIC) compared to restoration with calcium hydroxide restoration associated with high viscosity glass ionomer cement (HVGIC) for treatment of deep lesions in primary molars, as well as the impact of treatment in the criteria focused on the patient as well as cost-efficacy of the techniques . Children with 4 to 8 years will be selected randomly at the Clinic for Children at the University Ibirapuera of Dentistry. 108 teeth will be randomized into two groups: (1) restoration with calcium hydroxide cement associated with HVGIC and (2) HVGIC restoration. The restorations will be evaluated after 6, 12 and 24 months by two trained examiners blinded to the treatments. The efficacy of each treatment is measured by four main outcomes, which are: (1) criteria related to the effectiveness of the restorative treatment (2) criteria focused on the patient and (3) cost-efficacy. For comparison between the two groups will be used the Kaplan-Meier survival and the long-rank test. Cox regression is performed the assessment of the influence of some other variable results. For all analyzes, the significance level is set at 5%.


Eligibility criteria: Inclusion Criteria:

* Children will be included that have at least one primary molar with deep cavitated carious lesions in occlusal surface.

Exclusion Criteria:

* Patients will be excluded with special needs, using orthodontics devices and / or systemic diseases which may affect the oral cavity. Also, teeth with pulp exposure, spontaneous pain, mobility, presence of abscess or fistula next to the tooth, teeth with restorations, sealants or enamel formation defects will also be excluded.

Primary outcomes:
measure: Pulp Vitality
timeFrame: Up to 24 months
Secondary outcomes:
measure: Wong-Baker scale to discomfort
timeFrame: Immediately to restoration procedure.
measure: Cost-efficacy analysis by total value of treatment in relation to efficacy
timeFrame: Up to 24 months
measure: Restoration longevity
timeFrame: Up to 24 months.
measure: Caries progression
timeFrame: Up to 24 months.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Universidade Ibirapuera
state: SP
Study officials:
References:
citation: da Silva GSQ, Raggio DP, Machado GFR, Mello-Moura ACV, Gimenez T, Floriano I, Tedesco TK. Impact of different restorative treatments for deep caries lesion in primary teeth (CEPECO 1) - study protocol for a noninferiority randomized clinical trial. BMC Oral Health. 2019 Jan 8;19(1):6. doi: 10.1186/s12903-018-0703-3.