NCT02494193

Indirect Pulp Capping With Resin Modified Glass Ionomer

Indirect Pulp Capping With Resin Modified Glass Ionomer: a Randomized Controled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Universidade Federal de Sergipe · Academic / Other
• Sex: All
• Age: 15 Years – 30 Years
• Healthy volunteers: Accepted

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.

Conditions

• Caries, Dental
• Pulpitis

Interventions

Type	Name	Description
OTHER	Partial caries removal	The caries infected dentin will be removed mantaining the affected caries tissue.
OTHER	Provisional 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.
OTHER	Provisional restoration - experimental	After partial caries removal, a provisional restoration will be performed using only resin-modified glass ionomer.
OTHER	Total caries removal	After two months of their placement, the provisional restoration will removed followed by tota caries tissue removal.
OTHER	Definitive restoration	Definite restoration will be performed using composite.

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-09-01
• Completion: 2016-12-01
• First posted: 2015-07-10
• Last updated: 2017-05-03

Locations

1 site across 1 country: Brazil