Ignite Creation Date:
2024-05-06 @ 7:12 AM
Last Modification Date:
2024-10-26 @ 11:46 AM
Study NCT ID:
NCT02494193
Status:
COMPLETED
Last Update Posted:
2017-05-03
First Post:
2015-06-30
Brief Title:
Indirect Pulp Capping With Resin Modified Glass Ionomer
Sponsor:
Universidade Federal de Sergipe
Organization:
Universidade Federal de Sergipe
Study Overview
Official Title:
Indirect Pulp Capping With Resin Modified Glass Ionomer a Randomized Controled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor premolars n56 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 23 of dentin observed in bite-wing radiography without pulp involving andor 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None