Indirect Pulp Capping With Resin Modified Glass Ionomer
1 other identifier
interventional
112
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 30, 2015
CompletedFirst Posted
Study publicly available on registry
July 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedMay 3, 2017
May 1, 2017
1.3 years
June 30, 2015
May 2, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Tooth vitality - analysis for positive or negative response
2 months after placement of provisional restoration
Secondary Outcomes (4)
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
Study Arms (2)
Regular Treatment
ACTIVE COMPARATORPartial caries removal; Provisional restoration - control; Total caries removal; Definitive restoration.
Alternative Treatment
EXPERIMENTALPartial caries removal; Provisional restoration - experimental; Total caries removal; Definitive restoration.
Interventions
The caries infected dentin will be removed mantaining the affected caries tissue.
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.
After partial caries removal, a provisional restoration will be performed using only resin-modified glass ionomer.
After two months of their placement, the provisional restoration will removed followed by tota caries tissue removal.
Definite restoration will be performed using composite.
Eligibility Criteria
You may qualify if:
- Molars and pre-molars presenting carious lesions involving 2/3 inner of dentin tissue.
You may not qualify if:
- Teeth presenting signs of irreversible pulpits or necrose, cervical lesion and/or root exposition, or with carious lesion reaching the pulp.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidade Federal de Sergipe
Aracaju, Sergipe, 49060100, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
June 30, 2015
First Posted
July 10, 2015
Study Start
June 1, 2015
Primary Completion
September 1, 2016
Study Completion
December 1, 2016
Last Updated
May 3, 2017
Record last verified: 2017-05