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Dental Restorations Effect on Oxidative Status of the Gingival Crevicular Fluid

Redox Interactions Between Dental Restorations and Gingival Crevicular Fluid

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03522532
Enrollment
88
Registered
2018-05-11
Start date
2016-10-31
Completion date
2017-11-30
Last updated
2018-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacological Action

Keywords

dental restorations, gingival crevicular fluid, glutathione, lipid peroxidation, superoxide dismutase

Brief summary

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

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.

Interventions

PROCEDUREAmalgam placement

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

PROCEDURETetric EvoCeram placement

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

PROCEDUREBeautifil placement

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

PROCEDUREZinc 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.

PROCEDUREZinc 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.

PROCEDUREGlass 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.

Sponsors

University of Belgrade
CollaboratorOTHER
Ervin Taso
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention 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).

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in the levels of MDA in dental patients GCF after the applied treatments0th, 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

MeasureTime frameDescription
Changes in the levels of GSH in dental patients GCF after the applied treatments0th, 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

MeasureTime frameDescription
Changes in tSOD activity in dental patients GCF after the applied treatments0th, 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.

Countries

Serbia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026