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Dental Restorations Effect on Oxidative Status of the Gingival Crevicular Fluid

E

Ervin Taso

Status

Completed

Conditions

Pharmacological Action

Treatments

Procedure: Zinc polycarboxylate cement placement
Procedure: Amalgam placement
Procedure: Zinc phosphate cement placement
Procedure: Beautifil placement
Procedure: Glass ionomer cement placement
Procedure: Tetric EvoCeram placement

Study type

Interventional

Funder types

Other

Identifiers

NCT03522532
VMA/10-12/A.1

Details and patient eligibility

About

The goal of the study was to ascertain the influence of dental caries and teeth position as well as the type and amount of the applied dental materials (DMs) on the oxidative stress (OS) status in gingival crevicular fluid (GCF).

Full description

Six DMs were tested by investigators, each sealed in one session: amalgam (Amg), zinc phosphate cement (ZnPhC), zinc polycarboxylate cement (ZnPoC), glass ionomer cement (GIC) and composites, Tetric EvoCeram (TEC) and Beautifil (BF).

The study included 88 dental outpatients. Oxidative stress parameters, including malondialdehyde (MDA), glutathione (GSH) and total superoxide dismutase (tSOD) activity were measured in GCF, before (day 0) and after treatment (7th and 30th day).

Antagonistically positioned healthy teeth were used as a control.

Enrollment

88 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Criteria related to the condition of teeth:

  • Presence of proximal caries on anterior and posterior teeth
  • Existence of the antagonistic tooth ("mirror"-positioned healthy tooth) to be used as control
  • An absence of fresh post-extraction or traumatic wounds in the restoration area or in the area of restored surfaces
  • An absence of infection in the area of restored surfaces

Other influencing criteria:

  • Absence of bone-associated diseases or treatments
  • Satisfactory oral hygiene
  • Patients exhibiting good compliance

Exclusion criteria

Criteria related to the condition of teeth:

  • Endodontic and/or periodontal infections in the area of the cervical filling
  • Presence of periodontopathy
  • Prominent periodontal pockets
  • Subgingival carries
  • Prominent fillings outside the cavity

Other influencing criteria:

  • Patients on radiation or immunosuppressive therapy
  • Presence of bone-associated diseases and malignant diseases
  • Patients using drugs/alcohol/cigarettes (> 20 cigarettes per day)
  • Bad oral hygiene
  • Patients exhibiting poor compliance

Trial design

Primary purpose

Health Services Research

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

88 participants in 6 patient groups

Amalgam (Amg)
Experimental group
Description:
Amalgam was sealed in 8-K2 patients and 6-K2 patients. Oxidative stress parameters (MDA, GSH, tSOD) were measured in GCF prior to treatment and on the 7th and 30th day after treatment.
Treatment:
Procedure: Amalgam placement
Tetric EvoCeram (TEC)
Experimental group
Description:
Tetric EvoCeram was sealed in 12-K2 patients and 5-K5 patients. Oxidative stress parameters (MDA, GSH, tSOD) were measured in GCF prior to treatment and on the 7th and 30th day after treatment.
Treatment:
Procedure: Tetric EvoCeram placement
Beautifil (BF)
Experimental group
Description:
Beautifil was sealed in 15-K2 patients. Oxidative stress parameters (MDA, GSH, tSOD) were measured in GCF prior to treatment and on the 7th and 30th day after treatment.
Treatment:
Procedure: Beautifil placement
Zinc phosphate cement (ZPhC)
Experimental group
Description:
Zinc phosphate cement was sealed in 7-K2 patients, 4-K3 patients, 1-K4 patients and 2-K5 patients. Oxidative stress parameters (MDA, GSH, tSOD) were measured in GCF prior to treatment and on the 7th and 30th day after treatment.
Treatment:
Procedure: Zinc phosphate cement placement
Zinc polycarboxylate cement (ZPoC)
Experimental group
Description:
Zinc polycarboxylate cement was sealed in 5-K2 patients, 4-K3 patients and 5-K4 patients. Oxidative stress parameters (MDA, GSH, tSOD) were measured in GCF prior to treatment and on the 7th and 30th day after treatment.
Treatment:
Procedure: Zinc polycarboxylate cement placement
Glass ionomer cement (GIC)
Experimental group
Description:
Glass ionomer cement was sealed in 11-K2 patients, 2-K3 patients and 1-K5 patients. Oxidative stress parameters (MDA, GSH, tSOD) were measured in GCF prior to treatment and on the 7th and 30th day after treatment.
Treatment:
Procedure: Glass ionomer cement placement

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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