- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02494193
Indirect Pulp Capping With Resin Modified Glass Ionomer
May 2, 2017 updated by: André Luis Faria e Silva, Universidade Federal de Sergipe
Indirect Pulp Capping With Resin Modified Glass Ionomer: a Randomized Controled Clinical Trial
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
112
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
SE
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Aracaju, SE, Brazil, 49060100
- Universidade Federal de Sergipe
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 30 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Regular Treatment
Partial caries removal; Provisional restoration - control; Total caries removal; Definitive restoration.
|
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 two months of their placement, the provisional restoration will removed followed by tota caries tissue removal.
Definite restoration will be performed using composite.
|
Experimental: Alternative Treatment
Partial caries removal; Provisional restoration - experimental; Total caries removal; Definitive restoration.
|
The caries infected dentin will be removed mantaining the affected caries tissue.
After two months of their placement, the provisional restoration will removed followed by tota caries tissue removal.
Definite restoration will be performed using composite.
After partial caries removal, a provisional restoration will be performed using only resin-modified glass ionomer.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Tooth vitality - analysis for positive or negative response
Time Frame: 2 months after placement of provisional restoration
|
2 months after placement of provisional restoration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Consistency of dentin tissue - scores of 1 (softned) to 4 (hard)
Time Frame: Immediately after caries removal
|
Immediately after caries removal
|
Coloration of dentin tissue - scores of 1 (clear yellow) to 5 (darkd)
Time Frame: Immediately after caries removal
|
Immediately after caries removal
|
Counting of Streptococcus mutans colonies - number of colony-forming units (CFUs)
Time Frame: Immediately after caries removal
|
Immediately after caries removal
|
Counting of Lactobacillus spp colonies - number of colony-forming units (CFUs)
Time Frame: Immediately after caries removal
|
Immediately after caries removal
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2015
Primary Completion (Actual)
September 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
June 30, 2015
First Submitted That Met QC Criteria
July 7, 2015
First Posted (Estimate)
July 10, 2015
Study Record Updates
Last Update Posted (Actual)
May 3, 2017
Last Update Submitted That Met QC Criteria
May 2, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IPC (Other Identifier: University of Maia)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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