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Completed

NCT Number: NCT03522532

Dental Restorations Effect on Oxidative Status of the Gingival Crevicular Fluid

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).

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Key information

Conditions

Pharmacological Action

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Military Medical Academy

Belgrade, 11000, Serbia

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Amalgam placement

Procedure

Before the Amg was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment.

Tetric EvoCeram placement

Procedure

Before the TEC was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment.

Beautifil placement

Procedure

Before the BF was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment.

Zinc phosphate cement placement

Procedure

Before the ZPhC was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment.

Zinc polycarboxylate cement placement

Procedure

Before the ZPoC was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment.

Glass ionomer cement placement

Procedure

Before the GIC was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment.

Primary outcomes

  1. Changes in the levels of MDA in dental patients GCF after the applied treatments

    Time frame: 0th, 7th and 30th days.

    The concentration of MDA in GCF was measured before (0 day) and twice after the applied treatments (7th and 30th days). GCF was taken via the intracervical absorption technique. Control GCF (from mirror-positioned health teeth) was taken once before the treatment.

Secondary outcomes

  1. Changes in the levels of GSH in dental patients GCF after the applied treatments

    Time frame: 0th, 7th and 30th days.

    Concentration of GSH in GCF was measured before (0 day) and twice after the applied treatments (7th and 30th days). GCF was taken via the intracervical absorption technique. Control GCF (from mirror-positioned health teeth) was taken once before the treatment.

Other outcomes

  1. Changes in tSOD activity in dental patients GCF after the applied treatments

    Time frame: 0th, 7th and 30th days.

    Activity of tSOD was measured before (0 day) and twice after the applied treatments (7th and 30th days). GCF was taken via the intracervical absorption technique. Control GCF (from mirror-positioned health teeth) was taken once before the treatment.

Sponsors and collaborators

Lead sponsor

Ervin Taso

Other

Collaborators

  • University of Belgrade

Registry information

Official study title

Redox Interactions Between Dental Restorations and Gingival Crevicular Fluid

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 11, 2018
Registry last updated
May 11, 2018

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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