Dental Restorations Effect on Oxidative Status of the Gingival Crevicular Fluid

April 30, 2018 updated by: Ervin Taso

Redox Interactions Between Dental Restorations and 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).

Study Overview

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Belgrade, Serbia, 11000
        • Military Medical Academy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Amalgam (Amg)
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.
Before the Amg was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment.
EXPERIMENTAL: Tetric EvoCeram (TEC)
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.
Before the TEC was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment.
EXPERIMENTAL: Beautifil (BF)
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.
Before the BF was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment.
EXPERIMENTAL: Zinc phosphate cement (ZPhC)

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.

Before the ZPhC was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment.
EXPERIMENTAL: Zinc polycarboxylate cement (ZPoC)

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.

Before the ZPoC was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment.
EXPERIMENTAL: Glass ionomer cement (GIC)

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0th, 7th and 30th days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0th, 7th and 30th days.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0th, 7th and 30th days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

  • Principal Investigator: Mirjana M Djukic, PhD, Pharm., University of Belgrade
  • Study Director: Danilo V Vojvodic, Military Medical Academy, Belgrade

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2016

Primary Completion (ACTUAL)

September 1, 2017

Study Completion (ACTUAL)

November 1, 2017

Study Registration Dates

First Submitted

April 17, 2018

First Submitted That Met QC Criteria

April 30, 2018

First Posted (ACTUAL)

May 11, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 11, 2018

Last Update Submitted That Met QC Criteria

April 30, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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