Dental Restorations Effect on Oxidative Status of the Gingival Crevicular Fluid

Pharmacological Action Clinical Trial

Official title:

Redox Interactions Between Dental Restorations and Gingival Crevicular Fluid

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03522532
• Other study ID #: VMA/10-12/A.1
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: November 2017

Study information

• Verified date: April 2018
• Source: Military Medical Academy, Belgrade, Serbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: November 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pharmacological Action

Intervention

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

Locations

Country	Name	City	State
Serbia	Military Medical Academy	Belgrade

Sponsors (2)

Lead Sponsor	Collaborator
Ervin Taso	University of Belgrade

Country where clinical trial is conducted

Serbia, 

References & Publications (7)

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. — View 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. — View 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. — View Citation

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. — View 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). pii: E12. doi: 10.3390/dj5010012. Review. — View 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. Review. — View Citation

Stefanovic V, Taso E, Petkovic-Curcin A, Ðukic M, Gardaševic 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in tSOD activity in dental patients GCF after the applied treatments	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.	0th, 7th and 30th days.
Primary	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	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.