Deep Caries Lesion of Primary Teeth Clinical Trial
| NCT number | NCT02903979 |
| Other study ID # | UNIB1 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | November 2016 |
| Est. completion date | May 2020 |
| Verified date | June 2020 |
| Source | Universidade Ibirapuera |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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%.
| Status | Completed |
| Enrollment | 108 |
| Est. completion date | May 2020 |
| Est. primary completion date | March 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 4 Years to 8 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Universidade Ibirapuera | São Paulo | SP |
| Lead Sponsor | Collaborator |
|---|---|
| Universidade Ibirapuera |
Brazil,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pulp Vitality | To evaluate the survival of different restorative treatments considering the pulp vitality. | Up to 24 months | |
| Secondary | Wong-Baker scale to discomfort | To evaluate the discomfort of different restorative treatments by a Wong-Baker scale. | Immediately to restoration procedure. | |
| Secondary | Cost-efficacy analysis by total value of treatment in relation to efficacy | To evaluate the cost-efficacy of different restorative treatments by total value in dollar of treatment in relation to efficacy. The researchers would like to analyze that a treatment of low cost show the similar efficacy of a high cost treatment. | Up to 24 months | |
| Secondary | Restoration longevity | To evaluate the restoration longevity by clinical examination. | Up to 24 months. | |
| Secondary | Caries progression | To evaluate the caries progression by radiography. | Up to 24 months. |