Caries, Dental, Pulpitis
Conditions
Brief summary
In deep carious lesions, presenting risk of pulp exposition, a treatment option is the partial caries removal of carious tissue followed by provisional restoration, while this approach is called indirect pulp capping. The aim of this double-blinding controlled randomized clinical trial is to evaluate the success of indirect pulp capping using only resin-modified glass ionomer, while the additional layer of calcium hydroxide was used as control. The sample of 112 molars and/or premolars (n=56), presenting deep carious lesions, from patients with age between 15 and 30 years treated in dental clinic at Department of Dentistry of Federal University of Sergipe. The selected carious lesions must be reached 2/3 of dentin, observed in bite-wing radiography, without pulp involving and/or other factor that to compromise the evaluation. After detailed anamneses, the selected teeth will be radiographed e all carious tissue from surrounding walls will be removed. At the floor of cavity, the carious tissue will be partially removed using hand dentin excavators, remaining the caries-affected dentin and avoiding the pulp exposition. The removed carious tissue from the floor of cavity will be evaluated for presence of Lactobacilos e Estreptococos Mutans, while the remaining dentin will be evaluated for consistency, colour and humidity. Randomly, the cavity will be provisionally restored with: Control - dress and cement of calcium hydroxide followed resin-modified glass ionomer; or Experimental - only resin-modified glass ionomer. The distance between the base of restoration and the pulp cavity cap will be measured by bitw-wing radiography. The patients will be re-evaluated after 15 days, while the teeth with compromised pulp vitality will be excluded from the study. The remaining patients will be evaluated after 6 months. The distance between the base of restoration and the pulp cavity cap will be measured again, followed by provisional restoration removal. The remaining caries-affected dentin from floor of cavity will be fully removed and a bacteriological evaluation performed. The consistency, colour and humidity of this tissue will be evaluated too. Finally, the permanent restorations will performed.
Interventions
The caries infected dentin will be removed mantaining the affected caries tissue.
OTHERProvisional restoration - control
After partial caries removal, a provisional restoration will be performed using a layer of calcium hydroxide paste covered by a layer of calcium hydroxide cement and resin-modified glass ionomer.
OTHERProvisional restoration - experimental
After partial caries removal, a provisional restoration will be performed using only resin-modified glass ionomer.
OTHERTotal caries removal
After two months of their placement, the provisional restoration will removed followed by tota caries tissue removal.
OTHERDefinitive restoration
Definite restoration will be performed using composite.
Sponsors
Universidade Federal de Sergipe
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
15 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* Molars and pre-molars presenting carious lesions involving 2/3 inner of dentin tissue.
Exclusion criteria
* Teeth presenting signs of irreversible pulpits or necrose, cervical lesion and/or root exposition, or with carious lesion reaching the pulp.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tooth vitality - analysis for positive or negative response | 2 months after placement of provisional restoration |
Secondary
| Measure | Time frame |
|---|---|
| Consistency of dentin tissue - scores of 1 (softned) to 4 (hard) | Immediately after caries removal |
| Coloration of dentin tissue - scores of 1 (clear yellow) to 5 (darkd) | Immediately after caries removal |
| Counting of Streptococcus mutans colonies - number of colony-forming units (CFUs) | Immediately after caries removal |
| Counting of Lactobacillus spp colonies - number of colony-forming units (CFUs) | Immediately after caries removal |
Countries
Brazil
Outcome results
None listed