- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03522532
Dental Restorations Effect on Oxidative Status of the Gingival Crevicular Fluid
Redox Interactions Between Dental Restorations and Gingival Crevicular Fluid
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Belgrade, Serbia, 11000
- Military Medical Academy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
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. |
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. |
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. |
Before the GIC was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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0th, 7th and 30th days.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
0th, 7th and 30th days.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
0th, 7th and 30th days.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mirjana M Djukic, PhD, Pharm., University of Belgrade
- Study Director: Danilo V Vojvodic, Military Medical Academy, Belgrade
Publications and helpful links
General 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):12. doi: 10.3390/dj5010012.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VMA/10-12/A.1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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