InflammationNCT06507592
Oxidative-reductive Processes and the Degree of Inflammation in Saliva With Conventional Brackets and Clear Aligners
A study testing Saliva samples collection in people with Inflammation and Oxidative Stress, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial summary
The purpose of this prospective observational study is to evaluate the differences in oxidative-reductive processes and the degree of inflammation in saliva during treatment with conventional brackets and clear aligners. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Oxidative Stress, TNF-α
- What is being tested?
- Saliva samples collection
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteItaly
- Study dates
- 27 Jan 2023to 21 Dec 2024
- 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 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- age between 10 and 18 years
- patients with no orthodontic devices in the mouth
- patients requiring orthodontic treatment
- patients who have good oral hygiene
- patients without gingival inflammation
Who cannot join
- patients with systemic diseases or infections
- patients with previous orthodontic treatments
- patients on drugs or assuming alcohol
- smoking patients
- patients with enamel decalcification or fillings
Trial locations and contacts
1 site in 1 country.
Italy1 site
Multidisciplinary Department of Medical-Surgical and Dental Specialties
Naples, 80138
About this study
Official title: In Vivo Evaluation of the Differences in Oxidative-reductive Processes in Saliva During Treatment With Conventional Brackets and Clear Aligners
The purpose of this prospective observational study is to evaluate the differences in oxidative-reductive processes and the degree of inflammation in saliva during treatment with conventional brackets and clear aligners. The evaluation will be performed by determining the salivary values of Total oxidant status (TOS), total antioxidant status (TAS) and 8-hidroxy-2'-deoxyguanosine (8OHdG).
Read the detailed description
The differences between production of free radicals and the antioxidant capacity of a system is called oxidative stress, this leads oxidative damages to macromolecules, including lipids and proteins.
Oxidative stress occurs in the tissues when the normal balance between ROS production (extracellular Reactive Oxygen Species) and the antioxidant defense shifts in favor of the first; this situation can result from an excess of ROS and/or the reduction of antioxidants. Some ROS types (e.g. superoxide and hydroxyl radicals, hydrogen peroxide, hypochlorous acid) are capable to directly damage proteins, carbohydrates, DNA and lipids; furthermore, ROS production and an altered redox state of tissues can modulate the expression of a variety of immune and inflammatory molecules through redox sensitive transcription factors (eg NF-kB, AP-1), causing thus indirect tissue damage such as inflammation.
Antioxidants agents are found in all biological species to protect against the potential harmful effects of processes or reactions that cause excessive oxidation. Therefore, biological antioxidants represent an important part of our diet and, together with intracellular antioxidants and antioxidant enzyme systems, may prevent various diseases. Antioxidant defense systems are very complex and for this reason it is essential to evaluate the quantity and / or activity of the different systems when evaluating their in vivo state.
Studies on the antioxidant defense systems present in saliva and their relationship with oral diseases are still few. Despite markers of oxidative stress have been found in saliva in presence of systemic and oral diseases, including inflammatory diseases such as gingivitis, periodontitis, caries and oral cancer.4, 15 During an orthodontic treatment, which often lasts for years, some components of the used orthodontic appliance can be released into the oral environment and saliva. The release of these components and their diffusion can cause various adverse effects in the body, such as allergic reactions, systemic toxicity, cytotoxicity, mutagenicity and carcinogenicity. Although there has been satisfactory development of orthodontic materials, the biocompatibility of these materials is usually not well known. The evaluation of these characteristics of orthodontic materials is as important aspect as their physiological or mechanical properties. However, the studies on these characteristics are limited, and they are mostly related to the cytotoxic effects of orthodontic adhesives. The total state of the oxidant (TOS) and the antioxidant (TAS) reflects the oxidative state and provides information on the body's antioxidant capacity. Oxidative damage to DNA can be detected by chemical, physical and enzymatic methods. 8-hydroxyoxiguanosin (8-OHdG) is an oxidized nucleoside which is excreted in body fluids for DNA repair. Several studies have shown that 8-OHdG in body fluids can act as a biomarker of oxidative stress and 8-OHdG is commonly used as a marker to evaluate oxidative DNA damage in disorders including chronic inflammatory diseases. Previous studies have in fact indicated a possible relationship between the salivary levels of 8-OHdG and the diseased periodontium. However, the levels of TOS, TAS and 8-OHdG in patients undergoing therapy with conventional brackets and with clear aligners has not yet been studied.
- Conditions
- Inflammation, Oxidative Stress, TNF-α
- Being tested
- Saliva samples collection
- Keywords
- clear aligners, fixed appliances, oxidative stress, inflammation, orthodontic treatment
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saliva samples collectionDiagnostic test
The first sample of saliva was be taken before the start of the treatment and considered as the control sample (T0); the second sample was be taken one month after the start of the treatment (T1) and the third one after three months (T2).
| Study group | Role | What they receive |
|---|---|---|
| Fixed Appliances (FA) | Other | 13 patients with fixed appliances, between 10 and 18 years of age, with good oral hygiene and without gingival inflammation, has been recruited Receives: Diagnostic Test: Saliva samples collection |
| Clear Aligners (CA) | Other | 13 patients with clear aligners, between 10 and 18 years of age, with good oral hygiene and without gingival inflammation, has been recruited Receives: Diagnostic Test: Saliva samples collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxidative-reduction and inflammation
The Total Antioxidant Status (TAS) in saliva samples was measured using a N 2 615700-1KIT Total Antioxidant Status Assay Kit, a colorimetric assay for antioxidant levels in serum or plasma. The Total Oxidant Status (TOS) was measured with a CS0790-1KT Antioxidant Assay Kit, which includes all necessary reagents to measure total antioxidant capacity in plasma, serum, urine, saliva, cells, and tissue lysates. It also measures the radical cation (ABTS+) scavenging capacity. The 8-Hydroxy-2'-deoxyguanosine (8-OHdG) and Tumor Necrosis Factor-α (TNF-α) levels were determined using an E-EL-H0109 HUMAN TNF-ALPHA ELISA KIT, which detects protein levels quantitatively in serum, plasma, or cell lysate supernatants.
Measured: One year
Secondary outcomes (1)
Potential risk factors
Using plastic-based or metallic materials for orthodontic devices can increase saliva's oxidative and inflammatory status, potentially correlating with conditions like gingivitis, dental caries, periodontitis, or minor lesions such as aphthous ulcers. Oxidative stress impairs the ability to counteract further pathological events. Free radicals or reactive oxygen species (ROS) are typically generated during biochemical redox reactions as part of normal cell metabolism (for protection against infectious agents) and in response to environmental factors like UV radiation, cigarette smoke, pollutants, and gamma radiation. Once formed, ROS can attack cellular components in the mouth, damaging lipids, proteins, and DNA in oral tissues. This damage can initiate or exacerbate oral diseases, including gingivitis, dental caries, periodontitis, and other inflammatory conditions.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start27 Jan 2023
- Primary completion31 May 2024
- Study completion21 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vincenzo Grassia, University of Campania Luigi Vanvitelli
- Investigators
- Vincenzo Grassia, DDs, PhD, Principal investigator, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507592
- Sponsor's protocol ID
- N. Prot. 0637
- Status last verified
- Jul 2024
- First submitted
- 3 Jun 2024
- Last updated
- 18 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: anyone can contact the PI by mail and ask two share the IPD. All data will be stored in a cloud available by University of Campania. The PI will share a link to accede to the files.
Publications
Schipper RG, Silletti E, Vingerhoeds MH. Saliva as research material: biochemical, physicochemical and practical aspects. Arch Oral Biol. 2007 Dec;52(12):1114-35. doi: 10.1016/j.archoralbio.2007.06.009. Epub 2007 Aug 10.
PubMed 17692813Kovac V, Poljsak B, Perinetti G, Primozic J. Systemic Level of Oxidative Stress during Orthodontic Treatment with Fixed Appliances. Biomed Res Int. 2019 May 23;2019:5063565. doi: 10.1155/2019/5063565. eCollection 2019.
PubMed 31240214Angelieri F, Carlin V, Martins RA, Ribeiro DA. Biomonitoring of mutagenicity and cytotoxicity in patients undergoing fixed orthodontic therapy. Am J Orthod Dentofacial Orthop. 2011 Apr;139(4 Suppl):e399-404. doi: 10.1016/j.ajodo.2009.06.029.
PubMed 21435548Guler C, Toy E, Ozturk F, Gunes D, Karabulut AB, Otlu O. Evaluation of salivary total oxidant-antioxidant status and DNA damage of children undergoing fixed orthodontic therapy. Angle Orthod. 2015 Mar;85(2):239-44. doi: 10.2319/110113-798.1. Epub 2014 Jun 20.
PubMed 24949910Krifka S, Hiller KA, Spagnuolo G, Jewett A, Schmalz G, Schweikl H. The influence of glutathione on redox regulation by antioxidant proteins and apoptosis in macrophages exposed to 2-hydroxyethyl methacrylate (HEMA). Biomaterials. 2012 Jul;33(21):5177-86. doi: 10.1016/j.biomaterials.2012.04.013. Epub 2012 Apr 24.
PubMed 22534037Ambati M, Rani KR, Reddy PV, Suryaprasanna J, Dasari R, Gireddy H. Evaluation of oxidative stress in chronic periodontitis patients following systemic antioxidant supplementation: A clinical and biochemical study. J Nat Sci Biol Med. 2017 Jan-Jun;8(1):99-103. doi: 10.4103/0976-9668.198366.
PubMed 28250683Ichiishi E, Li XK, Iorio EL. Oxidative Stress and Diseases: Clinical Trials and Approaches. Oxid Med Cell Longev. 2016;2016:3458276. doi: 10.1155/2016/3458276. Epub 2016 Oct 19. No abstract available.
PubMed 27833701Chiou CC, Chang PY, Chan EC, Wu TL, Tsao KC, Wu JT. Urinary 8-hydroxydeoxyguanosine and its analogs as DNA marker of oxidative stress: development of an ELISA and measurement in both bladder and prostate cancers. Clin Chim Acta. 2003 Aug;334(1-2):87-94. doi: 10.1016/s0009-8981(03)00191-8.
PubMed 12867278Evans MD, Dizdaroglu M, Cooke MS. Oxidative DNA damage and disease: induction, repair and significance. Mutat Res. 2004 Sep;567(1):1-61. doi: 10.1016/j.mrrev.2003.11.001.
PubMed 15341901undefined
Kaplan MD, Baum BJ. The functions of saliva. Dysphagia. 1993;8(3):225-9. doi: 10.1007/BF01354542.
PubMed 8359042Cuevas-Cordoba B, Santiago-Garcia J. Saliva: a fluid of study for OMICS. OMICS. 2014 Feb;18(2):87-97. doi: 10.1089/omi.2013.0064. Epub 2014 Jan 3.
PubMed 24404837Humphrey SP, Williamson RT. A review of saliva: normal composition, flow, and function. J Prosthet Dent. 2001 Feb;85(2):162-9. doi: 10.1067/mpr.2001.113778.
PubMed 11208206Takane M, Sugano N, Iwasaki H, Iwano Y, Shimizu N, Ito K. New biomarker evidence of oxidative DNA damage in whole saliva from clinically healthy and periodontally diseased individuals. J Periodontol. 2002 May;73(5):551-4. doi: 10.1902/jop.2002.73.5.551.
PubMed 12027259Sezer U, Cicek Y, Canakci CF. Increased salivary levels of 8-hydroxydeoxyguanosine may be a marker for disease activity for periodontitis. Dis Markers. 2012;32(3):165-72. doi: 10.3233/DMA-2011-0876.
PubMed 22377732
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Evaluation of the Differences in Oxidative-reductive Processes in Saliva During Treatment With Conventional Brackets and Clear Aligners
- ClinicalTrials.gov ID
- NCT06507592
- Acronym / sponsor ID
- N. Prot. 0637
- Conditions
- Inflammation, Oxidative Stress, TNF-α
- Keywords
- clear aligners, fixed appliances, oxidative stress, inflammation, orthodontic treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 27 Jan 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 21 Dec 2024 (estimated)
- First posted
- 18 Jul 2024 (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 purpose of this prospective observational study is to evaluate the differences in oxidative-reductive processes and the degree of inflammation in saliva during treatment with conventional brackets and clear aligners. The evaluation will be performed by determining the salivary values of Total oxidant status (TOS), total antioxidant status (TAS) and 8-hidroxy-2'-deoxyguanosine (8OHdG).
Detailed description
The differences between production of free radicals and the antioxidant capacity of a system is called oxidative stress, this leads oxidative damages to macromolecules, including lipids and proteins.
Oxidative stress occurs in the tissues when the normal balance between ROS production (extracellular Reactive Oxygen Species) and the antioxidant defense shifts in favor of the first; this situation can result from an excess of ROS and/or the reduction of antioxidants. Some ROS types (e.g. superoxide and hydroxyl radicals, hydrogen peroxide, hypochlorous acid) are capable to directly damage proteins, carbohydrates, DNA and lipids; furthermore, ROS production and an altered redox state of tissues can modulate the expression of a variety of immune and inflammatory molecules through redox sensitive transcription factors (eg NF-kB, AP-1), causing thus indirect tissue damage such as inflammation.
Antioxidants agents are found in all biological species to protect against the potential harmful effects of processes or reactions that cause excessive oxidation. Therefore, biological antioxidants represent an important part of our diet and, together with intracellular antioxidants and antioxidant enzyme systems, may prevent various diseases. Antioxidant defense systems are very complex and for this reason it is essential to evaluate the quantity and / or activity of the different systems when evaluating their in vivo state.
Studies on the antioxidant defense systems present in saliva and their relationship with oral diseases are still few. Despite markers of oxidative stress have been found in saliva in presence of systemic and oral diseases, including inflammatory diseases such as gingivitis, periodontitis, caries and oral cancer.4, 15 During an orthodontic treatment, which often lasts for years, some components of the used orthodontic appliance can be released into the oral environment and saliva. The release of these components and their diffusion can cause various adverse effects in the body, such as allergic reactions, systemic toxicity, cytotoxicity, mutagenicity and carcinogenicity. Although there has been satisfactory development of orthodontic materials, the biocompatibility of these materials is usually not well known. The evaluation of these characteristics of orthodontic materials is as important aspect as their physiological or mechanical properties. However, the studies on these characteristics are limited, and they are mostly related to the cytotoxic effects of orthodontic adhesives. The total state of the oxidant (TOS) and the antioxidant (TAS) reflects the oxidative state and provides information on the body's antioxidant capacity. Oxidative damage to DNA can be detected by chemical, physical and enzymatic methods. 8-hydroxyoxiguanosin (8-OHdG) is an oxidized nucleoside which is excreted in body fluids for DNA repair. Several studies have shown that 8-OHdG in body fluids can act as a biomarker of oxidative stress and 8-OHdG is commonly used as a marker to evaluate oxidative DNA damage in disorders including chronic inflammatory diseases. Previous studies have in fact indicated a possible relationship between the salivary levels of 8-OHdG and the diseased periodontium. However, the levels of TOS, TAS and 8-OHdG in patients undergoing therapy with conventional brackets and with clear aligners has not yet been studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fixed Appliances (FA) | Other | Diagnostic Test: Saliva samples collection13 patients with fixed appliances, between 10 and 18 years of age, with good oral hygiene and without gingival inflammation, has been recruited |
| Clear Aligners (CA) | Other | Diagnostic Test: Saliva samples collection13 patients with clear aligners, between 10 and 18 years of age, with good oral hygiene and without gingival inflammation, has been recruited |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- age between 10 and 18 years
- patients with no orthodontic devices in the mouth
- patients requiring orthodontic treatment
- patients who have good oral hygiene
- patients without gingival inflammation
Key exclusion criteria (5 listed)
- patients with systemic diseases or infections
- patients with previous orthodontic treatments
- patients on drugs or assuming alcohol
- smoking patients
- patients with enamel decalcification or fillings
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 |
|---|---|---|
| Saliva samples collectionThe first sample of saliva was be taken before the start of the treatment and considered as the control sample (T0); the second sample was be taken one month after the start of the treatment (T1) and the third one after three months (T2). | Diagnostic test | Clear Aligners (CA), Fixed Appliances (FA) |
Primary outcome
Oxidative-reduction and inflammation
Time frame: One year
The Total Antioxidant Status (TAS) in saliva samples was measured using a N 2 615700-1KIT Total Antioxidant Status Assay Kit, a colorimetric assay for antioxidant levels in serum or plasma. The Total Oxidant Status (TOS) was measured with a CS0790-1KT Antioxidant Assay Kit, which includes all necessary reagents to measure total antioxidant capacity in plasma, serum, urine, saliva, cells, and tissue lysates. It also measures the radical cation (ABTS+) scavenging capacity. The 8-Hydroxy-2'-deoxyguanosine (8-OHdG) and Tumor Necrosis Factor-α (TNF-α) levels were determined using an E-EL-H0109 HUMAN TNF-ALPHA ELISA KIT, which detects protein levels quantitatively in serum, plasma, or cell lysate supernatants.
1 secondary outcome
Potential risk factors
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Background: PubMed 17692813Schipper RG, Silletti E, Vingerhoeds MH. Saliva as research material: biochemical, physicochemical and practical aspects. Arch Oral Biol. 2007 Dec;52(12):1114-35. doi: 10.1016/j.archoralbio.2007.06.009. Epub 2007 Aug 10.
- Background: PubMed 31240214Kovac V, Poljsak B, Perinetti G, Primozic J. Systemic Level of Oxidative Stress during Orthodontic Treatment with Fixed Appliances. Biomed Res Int. 2019 May 23;2019:5063565. doi: 10.1155/2019/5063565. eCollection 2019.
- Background: PubMed 21435548Angelieri F, Carlin V, Martins RA, Ribeiro DA. Biomonitoring of mutagenicity and cytotoxicity in patients undergoing fixed orthodontic therapy. Am J Orthod Dentofacial Orthop. 2011 Apr;139(4 Suppl):e399-404. doi: 10.1016/j.ajodo.2009.06.029.
- Background: PubMed 24949910Guler C, Toy E, Ozturk F, Gunes D, Karabulut AB, Otlu O. Evaluation of salivary total oxidant-antioxidant status and DNA damage of children undergoing fixed orthodontic therapy. Angle Orthod. 2015 Mar;85(2):239-44. doi: 10.2319/110113-798.1. Epub 2014 Jun 20.
- Background: PubMed 22534037Krifka S, Hiller KA, Spagnuolo G, Jewett A, Schmalz G, Schweikl H. The influence of glutathione on redox regulation by antioxidant proteins and apoptosis in macrophages exposed to 2-hydroxyethyl methacrylate (HEMA). Biomaterials. 2012 Jul;33(21):5177-86. doi: 10.1016/j.biomaterials.2012.04.013. Epub 2012 Apr 24.
- Background: PubMed 28250683Ambati M, Rani KR, Reddy PV, Suryaprasanna J, Dasari R, Gireddy H. Evaluation of oxidative stress in chronic periodontitis patients following systemic antioxidant supplementation: A clinical and biochemical study. J Nat Sci Biol Med. 2017 Jan-Jun;8(1):99-103. doi: 10.4103/0976-9668.198366.
- Background: PubMed 27833701Ichiishi E, Li XK, Iorio EL. Oxidative Stress and Diseases: Clinical Trials and Approaches. Oxid Med Cell Longev. 2016;2016:3458276. doi: 10.1155/2016/3458276. Epub 2016 Oct 19. No abstract available.
- Background: PubMed 12867278Chiou CC, Chang PY, Chan EC, Wu TL, Tsao KC, Wu JT. Urinary 8-hydroxydeoxyguanosine and its analogs as DNA marker of oxidative stress: development of an ELISA and measurement in both bladder and prostate cancers. Clin Chim Acta. 2003 Aug;334(1-2):87-94. doi: 10.1016/s0009-8981(03)00191-8.
- Background: PubMed 15341901Evans MD, Dizdaroglu M, Cooke MS. Oxidative DNA damage and disease: induction, repair and significance. Mutat Res. 2004 Sep;567(1):1-61. doi: 10.1016/j.mrrev.2003.11.001.
- Backgroundundefined
- Background: PubMed 8359042Kaplan MD, Baum BJ. The functions of saliva. Dysphagia. 1993;8(3):225-9. doi: 10.1007/BF01354542.
- Background: PubMed 24404837Cuevas-Cordoba B, Santiago-Garcia J. Saliva: a fluid of study for OMICS. OMICS. 2014 Feb;18(2):87-97. doi: 10.1089/omi.2013.0064. Epub 2014 Jan 3.
- Individual participant dataSharing planned: Yes. anyone can contact the PI by mail and ask two share the IPD. All data will be stored in a cloud available by University of Campania. The PI will share a link to accede to the files.
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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.
Vincenzo Grassia, DDs, PhD principal investigator
University of Campania Luigi Vanvitelli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saliva samples collection in people with Inflammation and Oxidative Stress, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 18 Jul 2024. 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 Italy. 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?
Results are not available in the source record.
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?
Oxidative-reduction and inflammation (time frame: One year). 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 NCT06507592, which also lists 19 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 18 Jul 2024.