Indirect Pulp Capping With Resin Modified Glass Ionomer

NCT ID: NCT02494193

Last Updated: 2017-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2016-12-31

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.

Conditions

Caries, Dental; Pulpitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Regular Treatment

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

Group Type: ACTIVE_COMPARATOR

Partial caries removal

Intervention Type: OTHER

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

Provisional restoration - control

Intervention Type: 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.

Total caries removal

Intervention Type: OTHER

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

Definitive restoration

Intervention Type: OTHER

Definite restoration will be performed using composite.

Alternative Treatment

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

Group Type: EXPERIMENTAL

Partial caries removal

Intervention Type: OTHER

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

Provisional restoration - experimental

Intervention Type: OTHER

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

Total caries removal

Intervention Type: OTHER

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

Definitive restoration

Intervention Type: OTHER

Definite restoration will be performed using composite.

Interventions

Partial caries removal

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

Intervention Type: OTHER

Provisional restoration - control

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

Provisional restoration - experimental

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

Intervention Type: OTHER

Total caries removal

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

Intervention Type: OTHER

Definitive restoration

Definite restoration will be performed using composite.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Federal de Sergipe

OTHER

Sponsor Role: lead

Responsible Party

André Luis Faria e Silva

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidade Federal de Sergipe

Aracaju, Sergipe, Brazil

Countries

Brazil

Other Identifiers

IPC

Identifier Type: -

Identifier Source: org_study_id