Indirect Pulp Capping With Resin Modified Glass Ionomer

Not Applicable

Completed

• Conditions: Pulpitis; Caries, Dental
• Interventions: Other: Partial caries removal; Other: Provisional restoration - control; Other: Provisional restoration - experimental; Other: Total caries removal; Other: Definitive restoration

• Registration Number: NCT02494193
• Lead Sponsor: Universidade Federal de Sergipe

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-30
• Study First Submitted QC: 2015-07-07
• Study First Posted: 2015-07-10
• Primary Completion: 2016-09
• Study Completion: 2016-12
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regular Treatment	Definitive restoration	Partial caries removal; Provisional restoration - control; Total caries removal; Definitive restoration.
Regular Treatment	Provisional restoration - control	Partial caries removal; Provisional restoration - control; Total caries removal; Definitive restoration.
Regular Treatment	Total caries removal	Partial caries removal; Provisional restoration - control; Total caries removal; Definitive restoration.
Alternative Treatment	Partial caries removal	Partial caries removal; Provisional restoration - experimental; Total caries removal; Definitive restoration.
Alternative Treatment	Provisional restoration - experimental	Partial caries removal; Provisional restoration - experimental; Total caries removal; Definitive restoration.
Regular Treatment	Partial caries removal	Partial caries removal; Provisional restoration - control; Total caries removal; Definitive restoration.
Alternative Treatment	Definitive restoration	Partial caries removal; Provisional restoration - experimental; Total caries removal; Definitive restoration.
Alternative Treatment	Total caries removal	Partial caries removal; Provisional restoration - experimental; Total caries removal; Definitive restoration.

Primary Outcome Measures

Name	Time	Method
Tooth vitality - analysis for positive or negative response	2 months after placement of provisional restoration

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Universidade Federal de Sergipe; 🇧🇷 Aracaju, SE, Brazil