Dental Restorations Effect on Oxidative Status of the Gingival Crevicular Fluid

Not Applicable

Completed

• Conditions: Pharmacological Action
• Interventions: Procedure: Zinc phosphate cement placement; Procedure: Amalgam placement; Procedure: Tetric EvoCeram placement; Procedure: Beautifil placement; Procedure: Zinc polycarboxylate cement placement; Procedure: Glass ionomer cement placement

• Registration Number: NCT03522532
• Lead Sponsor: Ervin Taso

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.

Study Timeline

• Study Start: 2016-10
• Primary Completion: 2017-09
• Study Completion: 2017-11
• Status Verified: 2018-04
• Study First Submitted: 2018-04-17
• Study First Submitted QC: 2018-04-30
• Last Update Submitted: 2018-04-30
• Study First Posted: 2018-05-11
• Last Update Posted: 2018-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zinc phosphate cement (ZPhC)	Zinc phosphate cement placement	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.
Amalgam (Amg)	Amalgam placement	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.
Tetric EvoCeram (TEC)	Tetric EvoCeram placement	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.
Beautifil (BF)	Beautifil placement	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.
Zinc polycarboxylate cement (ZPoC)	Zinc polycarboxylate cement placement	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.
Glass ionomer cement (GIC)	Glass ionomer cement placement	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.

Primary Outcome Measures

Name	Time	Method
Changes in the levels of MDA in dental patients GCF after the applied treatments	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 Outcome Measures

Name	Time	Method
Changes in the levels of GSH in dental patients GCF after the applied treatments	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.

Trial Locations

Locations (1)

Military Medical Academy; 🇷🇸 Belgrade, Serbia