Dental Restorations Effect on Oxidative Status of the Gingival Crevicular Fluid

Study Overview
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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).

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.

Official Title
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Redox Interactions Between Dental Restorations and Gingival Crevicular Fluid

Conditions
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Pharmacological Action

Intervention / Treatment
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* Procedure: Amalgam placement
* Procedure: Tetric EvoCeram placement
* Procedure: Beautifil placement
* Procedure: Zinc phosphate cement placement
* Procedure: Zinc polycarboxylate cement placement
* Procedure: Glass ionomer cement placement


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amalgam (Amg)<br>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. | Procedure: Amalgam placement<br>* Before the Amg was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment.<br>|
| Experimental: Tetric EvoCeram (TEC)<br>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. | Procedure: Tetric EvoCeram placement<br>* Before the TEC was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment.<br>|
| Experimental: Beautifil (BF)<br>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. | Procedure: Beautifil placement<br>* Before the BF was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment.<br>|
| Experimental: Zinc phosphate cement (ZPhC)<br>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. | Procedure: Zinc phosphate cement placement<br>* Before the ZPhC was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment.<br>|
| Experimental: Zinc polycarboxylate cement (ZPoC)<br>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. | Procedure: Zinc polycarboxylate cement placement<br>* Before the ZPoC was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment.<br>|
| Experimental: Glass ionomer cement (GIC)<br>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. | Procedure: Glass ionomer cement placement<br>* Before the GIC was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the levels of MDA in dental patients GCF after the applied treatments | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dental restorations, gingival crevicular fluid, glutathione, lipid peroxidation, superoxide dismutase