Dental Restorations Effect on Oxidative Status of the Gingival Crevicular Fluid

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-11-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pharmacological Action

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

According to Black's Classification Criteria, patients were classified into four groups (K2 - K5). The number of patients within those groups were as follows: K2 (n=58), K3 (n=10), K4 (n=6) and K5 (n=14).

Six different DMs were used in this study. The type of DM to be used for each patient was determined in relation to the dental lesion degree. DM placement was performed in one session and only one type was used per patient. Accordingly, 6 groups (arms) of dental patients (Amg, ZnPhC, ZnPoC, GIC, TEC and BF) were formed.

Parameters of OS (MDA, GSH and tSOD) were measured in the GCF of the patients both before (day 0) and after treatment (on the 7th and 30th day).

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Amalgam placement

Intervention Type 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 (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.

Group Type EXPERIMENTAL

Tetric EvoCeram placement

Intervention Type PROCEDURE

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

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.

Group Type EXPERIMENTAL

Beautifil placement

Intervention Type 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 (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.

Group Type EXPERIMENTAL

Zinc phosphate cement placement

Intervention Type 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 (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.

Group Type EXPERIMENTAL

Zinc polycarboxylate cement placement

Intervention Type 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 (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.

Group Type EXPERIMENTAL

Glass ionomer cement placement

Intervention Type PROCEDURE

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

Interventions

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Amalgam placement

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

Intervention Type PROCEDURE

Tetric EvoCeram placement

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

Intervention Type PROCEDURE

Beautifil placement

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

Intervention Type PROCEDURE

Zinc phosphate cement placement

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

Intervention Type PROCEDURE

Zinc polycarboxylate cement placement

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

Intervention Type PROCEDURE

Glass ionomer cement placement

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No