Dental Restorations Effect on Oxidative Status of the Gingival Crevicular Fluid

NCT03522532 | Completed DMC

• 1 other identifier: VMA/10-12/A.1
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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).

Conditions

Pharmacological Action

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes in the levels of GSH in dental patients GCF after the applied treatments

  0th, 7th and 30th days.

Other Outcomes (1)

• Changes in tSOD activity in dental patients GCF after the applied treatments

  0th, 7th and 30th days.

Study Arms (6)

Amalgam (Amg)

EXPERIMENTAL

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

Tetric EvoCeram (TEC)

EXPERIMENTAL

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

Beautifil (BF)

EXPERIMENTAL

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

Zinc phosphate cement (ZPhC)

EXPERIMENTAL

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

Zinc polycarboxylate cement (ZPoC)

EXPERIMENTAL

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

Glass ionomer cement (GIC)

EXPERIMENTAL

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

Interventions

Amalgam placement PROCEDURE

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

Amalgam (Amg)

Tetric EvoCeram placement PROCEDURE

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

Tetric EvoCeram (TEC)

Beautifil placement PROCEDURE

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

Beautifil (BF)

Zinc phosphate cement placement PROCEDURE

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

Zinc phosphate cement (ZPhC)

Zinc polycarboxylate cement placement PROCEDURE

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

Zinc polycarboxylate cement (ZPoC)

Glass ionomer cement placement PROCEDURE

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

Glass ionomer cement (GIC)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ervin Taso: lead
• University of Belgrade: collaborator

Study Sites (1)

Military Medical Academy

Belgrade, 11000, Serbia

Location

Related Publications (7)

• 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.

  PMID: 29563418 BACKGROUND

• 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.

  PMID: 29328596 BACKGROUND

• 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. doi: 10.1172/JCI15021.

  PMID: 12021246 BACKGROUND

• 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.

  PMID: 22721943 BACKGROUND

• 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.

  PMID: 28102089 BACKGROUND

• 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.

  PMID: 28344087 BACKGROUND

• 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.

  PMID: 28074077 BACKGROUND

Study Officials

• Mirjana M Djukic, PhD, Pharm.

  University of Belgrade

  PRINCIPAL INVESTIGATOR

• Danilo V Vojvodic

  Military Medical Academy, Belgrade

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: May 11, 2018
• Study Start: October 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: November 1, 2017
• Last Updated: May 11, 2018

Record last verified: 2018-04

Locations

SE (1)