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Completed

NCT Number: NCT02494193

Indirect Pulp Capping With Resin Modified Glass Ionomer

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.

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Key information

Age range

15 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal de Sergipe

Aracaju, Sergipe, 49060100, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Partial caries removal

Other

The caries infected dentin will be removed mantaining the affected caries tissue.

Provisional restoration - control

Other

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.

Provisional restoration - experimental

Other

After partial caries removal, a provisional restoration will be performed using only resin-modified glass ionomer.

Total caries removal

Other

After two months of their placement, the provisional restoration will removed followed by tota caries tissue removal.

Definitive restoration

Other

Definite restoration will be performed using composite.

Primary outcomes

  1. Tooth vitality - analysis for positive or negative response

    Time frame: 2 months after placement of provisional restoration

Secondary outcomes

  1. Consistency of dentin tissue - scores of 1 (softned) to 4 (hard)

    Time frame: Immediately after caries removal

  2. Coloration of dentin tissue - scores of 1 (clear yellow) to 5 (darkd)

    Time frame: Immediately after caries removal

  3. Counting of Streptococcus mutans colonies - number of colony-forming units (CFUs)

    Time frame: Immediately after caries removal

  4. Counting of Lactobacillus spp colonies - number of colony-forming units (CFUs)

    Time frame: Immediately after caries removal

Sponsors and collaborators

Lead sponsor

Universidade Federal de Sergipe

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 10, 2015
Registry last updated
May 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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