Clinical trial NCT03522532: Dental Restorations Effect on Oxidative Status of the Gingival Crevicular Fluid
Official title: Redox Interactions Between Dental Restorations and Gingival Crevicular Fluid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pharmacological Action
Keywords: dental restorations
gingival crevicular fluid
glutathione
lipid peroxidation
superoxide dismutase
Lead sponsor: Military Medical Academy, Belgrade, Serbia
Sponsor class: OTHER
Collaborators: name: University of Belgrade
First posted: 2018-05-11
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: Changes in the levels of MDA in dental patients GCF after the applied treatments
timeFrame: 0th, 7th and 30th days.
Secondary outcomes:
measure: Changes in the levels of GSH in dental patients GCF after the applied treatments
timeFrame: 0th, 7th and 30th days.
Other outcomes:
measure: Changes in tSOD activity in dental patients GCF after the applied treatments
timeFrame: 0th, 7th and 30th days.
Locations:
city: Belgrade
country: Serbia
facility: Military Medical Academy
Study officials:
affiliation: University of Belgrade
name: Mirjana M Djukic, PhD, Pharm.
role: PRINCIPAL_INVESTIGATOR
affiliation: Military Medical Academy, Belgrade
name: Danilo V Vojvodic
role: STUDY_DIRECTOR
References:
citation: 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):12. doi: 10.3390/dj5010012.
citation: Stefanovic V, Taso E, Petkovic-Curcin A, Dukic M, Gardasevic M, Rakic M, Xavier S, Jovic M, Miller K, Stanojevic I, Vojvodic 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.