Pharmacological ActionNCT03522532
Dental Restorations Effect on Oxidative Status of the Gingival Crevicular Fluid
A study testing Amalgam placement, Tetric EvoCeram placement and Beautifil placement in people with Pharmacological Action, run by Ervin Taso at 1 site in Serbia.
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pharmacological Action
- What is being tested?
- Amalgam placement, Tetric EvoCeram placement and Beautifil placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteSerbia
- Study dates
- Oct 2016to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 9Show fewer
- Absence of bone-associated diseases or treatments
- Satisfactory oral hygiene
- Patients exhibiting good compliance
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Redox Interactions Between Dental Restorations and Gingival Crevicular Fluid
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).
Read the 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.
- Conditions
- Pharmacological Action
- Being tested
- Amalgam placement, Tetric EvoCeram placement, Beautifil placement, Zinc phosphate cement placement, Zinc polycarboxylate cement placement
- Keywords
- dental restorations, gingival crevicular fluid, glutathione, lipid peroxidation, superoxide dismutase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amalgam placementProcedure or surgery
Before the Amg was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment.
Tetric EvoCeram placementProcedure or surgery
Before the TEC was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment.
Beautifil placementProcedure or surgery
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 placementProcedure or surgery
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 placementProcedure or surgery
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 placementProcedure or surgery
Before the GIC was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Procedure: Glass ionomer cement placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0th, 7th and 30th days.
Secondary outcomes (1)
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.
Measured: 0th, 7th and 30th days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study startOct 2016
- Primary completionSep 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pharmacological ActionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ervin Taso
- Sponsor type
- University, hospital or other
- Collaborators
- University of Belgrade
- Responsible party
- Sponsor-investigator, Ervin Taso, Military Medical Academy, Belgrade, Serbia
- Investigators
- Mirjana M Djukic, PhD, Pharm., Principal investigator, University of BelgradeDanilo V Vojvodic, Study director, Military Medical Academy, Belgrade
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03522532
- Sponsor's protocol ID
- VMA/10-12/A.1
- Status last verified
- Apr 2018
- First submitted
- 17 Apr 2018
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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.
PubMed 29563418Stefanovic 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.
PubMed 29328596Gaut 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.
PubMed 12021246Djukic 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.
PubMed 22721943Begic 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.
PubMed 28102089Djuric 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.
PubMed 28344087Nazar 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.
PubMed 28074077
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Redox Interactions Between Dental Restorations and Gingival Crevicular Fluid
- ClinicalTrials.gov ID
- NCT03522532
- Acronym / sponsor ID
- VMA/10-12/A.1
- Conditions
- Pharmacological Action
- Keywords
- dental restorations, gingival crevicular fluid, glutathione, lipid peroxidation, superoxide dismutase
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Ervin TasoUniversity, hospital or other
- Collaborators
- University of Belgrade
- Study start
- Oct 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 11 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- 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).
| Arm | Type | Receives |
|---|---|---|
| Amalgam (Amg) | Experimental | Procedure: Amalgam placementAmalgam 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. |
| Tetric EvoCeram (TEC) | Experimental | Procedure: Tetric EvoCeram placementTetric 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. |
| Beautifil (BF) | Experimental | Procedure: Beautifil placementBeautifil 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. |
| Zinc phosphate cement (ZPhC) | Experimental | Procedure: Zinc phosphate cement placementZinc 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. |
| Zinc polycarboxylate cement (ZPoC) | Experimental | Procedure: Zinc polycarboxylate cement placementZinc 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. |
| Glass ionomer cement (GIC) | Experimental | Procedure: Glass ionomer cement placementGlass 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- Absence of bone-associated diseases or treatments
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amalgam placementBefore the Amg was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment. | Procedure or surgery | Amalgam (Amg) |
| Tetric EvoCeram placementBefore the TEC was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment. | Procedure or surgery | Tetric EvoCeram (TEC) |
| Beautifil placementBefore the BF was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment. | Procedure or surgery | Beautifil (BF) |
| Zinc phosphate cement placementBefore the ZPhC was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment. | Procedure or surgery | Zinc phosphate cement (ZPhC) |
| Zinc polycarboxylate cement placementBefore the ZPoC was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment. | Procedure or surgery | Zinc polycarboxylate cement (ZPoC) |
| Glass ionomer cement placementBefore the GIC was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment. | Procedure or surgery | Glass ionomer cement (GIC) |
Primary outcome
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.
1 secondary outcome
Changes in the levels of GSH in dental patients GCF after the applied treatments
Time frame: 0th, 7th and 30th days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Background: PubMed 29563418Khurshid 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.
- Background: PubMed 29328596Stefanovic 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.
- Background: PubMed 12021246Gaut 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.
- Background: PubMed 22721943Djukic 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.
- Background: PubMed 28102089Begic 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.
- Background: PubMed 28344087Djuric 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.
- Background: PubMed 28074077Nazar 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mirjana M Djukic, PhD, Pharm. principal investigator
University of Belgrade
Danilo V Vojvodic study director
Military Medical Academy, Belgrade
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amalgam placement, Tetric EvoCeram placement and Beautifil placement in people with Pharmacological Action, run by Ervin Taso at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the levels of MDA in dental patients GCF after the applied treatments (time frame: 0th, 7th and 30th days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03522532, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.