NCT03650647

Comparison of Conventional Versus Conservative Caries Removal in Primary Teeth

Randomized Clinical Trial Comparison of Conventional Versus Conservative Caries Removal in Primary Teeth: a Two-year Evaluation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Universidade Federal Fluminense · Academic / Other
• Sex: All
• Age: 4 Years – 6 Years
• Healthy volunteers: Accepted

Summary

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: * Clinical and Microbiological Research Laboratory (LAB PECMA - ISNF) - Sample storage, bacterial cultivation and identification. * University of North Carolina at Chapel Hill * Rio de Janeiro Federal University

Detailed description

The aims of this Randomized Clinical Trial are: 1. to evaluate the risk of pulpal exposure and tooth vitality maintenance of primary molars with deep caries lesions, treated with conservative techniques, such as Stepwise Excavation (SE) or Selective Caries Removal (SCR), and to compare with those teeth treated with Indirect Pulp Capping (IPC); 2. to verify changes in the cultivable microbiota isolated in the deep carious dentin lesions of deciduous molars, before and after performing the procedures of SE; 3. to clinically evaluate dentin reactions to the SE; 4. to provide longitudinal monitoring of changes in the non-cultivable microbiota (microbiome), found in dentin carious lesions of deciduous and permanent molars, compared to the treatments performed; 5. to determine, in vitro, the microbial metabolome of different strains isolated from dentin samples under conditions of high and low cariogenic challenge; 6. to correlate, in vitro, the microbial metabolites with the clinical classification of the cavitated lesions from which these samples originated. 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

Conditions

• Dental Caries Extending Into Dentin

Interventions

Type	Name	Description
PROCEDURE	Carious dentin removal	Carious tissue removal and managing deep cavitated carious lesions in primary teeth.

Timeline

• Start date: 2017-01-15
• Primary completion: 2018-01-15
• Completion: 2020-01-05
• First posted: 2018-08-29
• Last updated: 2018-08-29