search
Back to results

Indirect Pulp Capping With Resin Modified Glass Ionomer

Primary Purpose

Caries, Dental, Pulpitis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Partial caries removal
Provisional restoration - control
Provisional restoration - experimental
Total caries removal
Definitive restoration
Sponsored by
Universidade Federal de Sergipe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Caries, Dental

Eligibility Criteria

15 Years - 30 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Universidade Federal de Sergipe

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Regular Treatment

Alternative Treatment

Arm Description

Partial caries removal; Provisional restoration - control; Total caries removal; Definitive restoration.

Partial caries removal; Provisional restoration - experimental; Total caries removal; Definitive restoration.

Outcomes

Primary Outcome Measures

Tooth vitality - analysis for positive or negative response

Secondary Outcome Measures

Consistency of dentin tissue - scores of 1 (softned) to 4 (hard)
Coloration of dentin tissue - scores of 1 (clear yellow) to 5 (darkd)
Counting of Streptococcus mutans colonies - number of colony-forming units (CFUs)
Counting of Lactobacillus spp colonies - number of colony-forming units (CFUs)

Full Information

First Posted
June 30, 2015
Last Updated
May 2, 2017
Sponsor
Universidade Federal de Sergipe
search

1. Study Identification

Unique Protocol Identification Number
NCT02494193
Brief Title
Indirect Pulp Capping With Resin Modified Glass Ionomer
Official Title
Indirect Pulp Capping With Resin Modified Glass Ionomer: a Randomized Controled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Sergipe

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caries, Dental, Pulpitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regular Treatment
Arm Type
Active Comparator
Arm Description
Partial caries removal; Provisional restoration - control; Total caries removal; Definitive restoration.
Arm Title
Alternative Treatment
Arm Type
Experimental
Arm Description
Partial caries removal; Provisional restoration - experimental; Total caries removal; Definitive restoration.
Intervention Type
Other
Intervention Name(s)
Partial caries removal
Intervention Description
The caries infected dentin will be removed mantaining the affected caries tissue.
Intervention Type
Other
Intervention Name(s)
Provisional restoration - control
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Provisional restoration - experimental
Intervention Description
After partial caries removal, a provisional restoration will be performed using only resin-modified glass ionomer.
Intervention Type
Other
Intervention Name(s)
Total caries removal
Intervention Description
After two months of their placement, the provisional restoration will removed followed by tota caries tissue removal.
Intervention Type
Other
Intervention Name(s)
Definitive restoration
Intervention Description
Definite restoration will be performed using composite.
Primary Outcome Measure Information:
Title
Tooth vitality - analysis for positive or negative response
Time Frame
2 months after placement of provisional restoration
Secondary Outcome Measure Information:
Title
Consistency of dentin tissue - scores of 1 (softned) to 4 (hard)
Time Frame
Immediately after caries removal
Title
Coloration of dentin tissue - scores of 1 (clear yellow) to 5 (darkd)
Time Frame
Immediately after caries removal
Title
Counting of Streptococcus mutans colonies - number of colony-forming units (CFUs)
Time Frame
Immediately after caries removal
Title
Counting of Lactobacillus spp colonies - number of colony-forming units (CFUs)
Time Frame
Immediately after caries removal

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Universidade Federal de Sergipe
City
Aracaju
State/Province
SE
ZIP/Postal Code
49060100
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Indirect Pulp Capping With Resin Modified Glass Ionomer

We'll reach out to this number within 24 hrs