Dental Restorations Effect on Oxidative Status of the Gingival Crevicular Fluid

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ClinicalTrials.gov Identifier: NCT03522532

Recruitment Status : Completed

First Posted : May 11, 2018

Last Update Posted : May 11, 2018

Sponsor:

Collaborator:

University of Belgrade

Information provided by (Responsible Party):

Ervin Taso, Military Medical Academy, Belgrade, Serbia

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Pharmacological Action	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	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	88 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
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).
Masking:	None (Open Label)
Primary Purpose:	Health Services Research
Official Title:	Redox Interactions Between Dental Restorations and Gingival Crevicular Fluid
Actual Study Start Date :	October 2016
Actual Primary Completion Date :	September 2017
Actual Study Completion Date :	November 2017

Arms and Interventions

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.	Procedure: Amalgam placement 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.	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.
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.	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.
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.	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.
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.	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.
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.	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.

Outcome Measures

Primary Outcome Measures :

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.

Secondary Outcome Measures :

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.

Other Outcome Measures:

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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522532

Locations

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Serbia
Military Medical Academy
Belgrade, Serbia, 11000

Sponsors and Collaborators

Ervin Taso

University of Belgrade

Investigators

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

More Information

Publications:

Khurshid Z, Mali M, Naseem M, Najeeb S, Zafar MS. Human Gingival Crevicular Fluids (GCF) Proteomics: An Overview. Dent J (Basel). 2017 Feb 22;5(1). pii: E12. doi: 10.3390/dj5010012. Review.

Stefanović V, Taso E, Petković-Ćurčin A, Đukić M, Gardašević M, Rakić M, Xavier S, Jović M, Miller K, Stanojević I, Vojvodić D. Influence of dental filling material type on the concentration of interleukin 9 in the samples of gingival crevicular fluid. Vojnosanit Pregl. 2016 Aug;73(8):728-34. doi: 10.2298/VSP140227054S.

Gaut JP, Byun J, Tran HD, Lauber WM, Carroll JA, Hotchkiss RS, Belaaouaj A, Heinecke JW. Myeloperoxidase produces nitrating oxidants in vivo. J Clin Invest. 2002 May;109(10):1311-9.

Djukic MM, Jovanovic MD, Ninkovic M, Stevanovic I, Ilic K, Curcic M, Vekic J. Protective role of glutathione reductase in paraquat induced neurotoxicity. Chem Biol Interact. 2012 Aug 30;199(2):74-86. doi: 10.1016/j.cbi.2012.05.008. Epub 2012 Jun 18.

Begic A, Djuric A, Ninkovic M, Stevanovic I, Djurdjevic D, Pavlovic M, Jelic K, Pantelic A, Zebic G, Dejanovic B, Stanojevic I, Vojvodic D, Milosavljevic P, Djukic M, Saso L. Disulfiram moderately restores impaired hepatic redox status of rats subchronically exposed to cadmium. J Enzyme Inhib Med Chem. 2017 Dec;32(1):478-489. doi: 10.1080/14756366.2016.1261132.

Djuric A, Begic A, Gobeljic B, Pantelic A, Zebic G, Stevanovic I, Djurdjevic D, Ninkovic M, Prokic V, Stanojevic I, Vojvodic D, Djukic M. Subacute alcohol and/or disulfiram intake affects bioelements and redox status in rat testes. Food Chem Toxicol. 2017 Jul;105:44-51. doi: 10.1016/j.fct.2017.03.041. Epub 2017 Mar 24.

Nazar Majeed Z, Philip K, Alabsi AM, Pushparajan S, Swaminathan D. Identification of Gingival Crevicular Fluid Sampling, Analytical Methods, and Oral Biomarkers for the Diagnosis and Monitoring of Periodontal Diseases: A Systematic Review. Dis Markers. 2016;2016:1804727. doi: 10.1155/2016/1804727. Epub 2016 Dec 15. Review.

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Responsible Party:	Ervin Taso, Principal Investigator, Military Medical Academy, Belgrade, Serbia
ClinicalTrials.gov Identifier:	NCT03522532
Other Study ID Numbers:	VMA/10-12/A.1
First Posted:	May 11, 2018 Key Record Dates
Last Update Posted:	May 11, 2018
Last Verified:	April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Keywords provided by Ervin Taso, Military Medical Academy, Belgrade, Serbia:


dental restorations gingival crevicular fluid glutathione lipid peroxidation superoxide dismutase

Additional relevant MeSH terms:

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Zinc Trace Elements Micronutrients Physiological Effects of Drugs

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