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The sample will be, at least, 90 primary molars, randomly distributed into three groups: Group 1: IPC; Group 2: SE; Group 3: SCR. Teeth must present deep caries lesions (at least 2/3 of dentin depth), pulp vitality (no clinical or radiographical signs of pulp disease, such as abcesses, fistulae, root resorption, abnormal tooth mobility). This study received approval by the Ethics Committee of Fluminense Federal University (UFF; Brazil) - # CAAE: 58812816.8.0000.5626. The study started in January, 2017; and will finish in December, 2020. Patients will be selected from the public schools in Nova Friburgo. The dental exams and treatment procedures will be done at the clinics from the
School of Dentistry, Health Institute of Nova Friburgo (ISNF). Laboratory proceedings will be done at:
The aims of this Randomized Clinical Trial are:
The sample will be, at least, 90 primary molars, randomly distributed into three groups: Group 1: IPC; Group 2: SE; Group 3: SCR. Teeth must present deep caries lesions (at least 2/3 of dentin depth), pulp vitality (no clinical or radiographical signs of pulp disease, such as abcesses, fistulae, root resorption, abnormal tooth mobility). This study received approval by the Ethics Committee of UFF (Brazil) - # CAAE: 58812816.8.0000.5626. The study started in January, 2017; and will finish in December, 2020. Patients will be selected from the public schools in Nova Friburgo. The dental exams and treatment procedures will be done at the clinics from the
School of Dentistry, Health Institute of Nova Friburgo (ISNF). Laboratory proceedings will be done at:
LAB PECMA - ISNF - Sample storage, bacterial cultivation and identification University of North Carolina at Chapel Hill Rio de Janeiro Federal University
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indirect Pulp Capping | Active Comparator | Nonselective removal to hard dentine (formerly complete excavation or complete caries removal) : removal of soft dentin, only hard dentine is left on the cavity, so that demineralized dentine "free" of bacteria is completely removed. Intervention: Total soft and leathery caries removal. Carious dentin removal |
|
| Stepwise excavation | Experimental | Stepwise removal is carious tissue removal in 2 stages, i.e., visits. Soft carious tissue is left over the pulp in the first step, while peripheral dentine is prepared to hard dentine to allow a complete and durable seal of the lesion. A provisional restoration is placed, which should be sufficiently durable to last up to 6 months to allow changes in the dentine and pulp to take place. After this period, a second excavation is done and, if there is hard dentin formed, the tooth is restored. Intervention: Part of the soft caries is removed. Final restoration is placed on the second visit. Carious dentin removal |
|
| Selective caries removal | Experimental | Selective caries removal: only part the soft dentine is removed, so soft carious tissue is left over the pulp, while peripheral enamel and dentine are prepared to hard dentine, to allow a tight seal and placement of a durable restoration. Intervention: Part of the soft caries is removed. Final restoration is place over the soft dentin. Carious dentin removal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carious dentin removal | Procedure | Carious tissue removal and managing deep cavitated carious lesions in primary teeth. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pulp vitality maintenance diagnosed by clinical exam | Among the three treatment protocols, which one will have better prognosis in maintaining pulp vitality. The clinical parameters of pulpal failures are: pain, presence of abscess, fistulae and/or abnormal tooth mobility. | Through study completion, up to three years. |
| Pulp vitality maintenance diagnosed by radiograph exam | The prognosis of maintaining pulp vitality will be acessed by radiological signs of loss of vitality, as presence of abnormal root resorption and/or bone resorption. | Through study completion, up to three years. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Apoena A Ribeiro, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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Tooth receive one of the two test treatments: Stepwise Excavation (conservative treatment 1), Selective caries removal (conservative treatment 2) and are evaluated in parallel against a control group (indirect pulp capping treatment).
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