Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06507592
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-06-03
Brief Title:
Oxidative-reductive Processes and the Degree of Inflammation in Saliva With Conventional Brackets and Clear Aligners
Sponsor:
None
Organization:
None
Study Overview
Official Title:
In Vivo Evaluation of the Differences in Oxidative-reductive Processes in Saliva During Treatment With Conventional Brackets and Clear Aligners
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 andor the reduction of antioxidants Some ROS types eg 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 cancer4 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 bodys 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
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 andor the reduction of antioxidants Some ROS types eg 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 cancer4 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 bodys 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None