Ignite Creation Date:
2024-05-06 @ 6:24 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05655923
Status:
RECRUITING
Last Update Posted:
2022-12-19
First Post:
2022-12-10
Brief Title:
Clinical and Biochemical Assessment of Ozonated Olive Oil Mixed Bone Substitute in Treating Intra Bony Periodontal Defect
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Clinical and Biochemical Assessment of Ozonated Olive Oil Mixed Bone Substitute in Treating Intra Bony Periodontal Defect- Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to investigate the effect of ozonated olive oil in treating intra bony defect by means of clinical and radiographic parameters and gingival cervicular fluid BMP2 level
Detailed Description:
Ozone is a triatomic molecule containing three oxygen atoms has many different uses in various fields one of them is a practice of ozone in medicine Seidler et al 2008 as well as in dentistry fieldAzarpazhooh Limeback 2008 Ozone is unstable gas and release rapidly a nascent oxygen molecule to form an oxygen gas due to this property ozone gas used to kill bacteria fungi Inactivate viruses and control bleedingGupta Mansi 2012
There are three different systems for producing ozone gas Ultraviolet System yields low concentrations of ozone used in saunas esthetics and for air decontamination Cold Plasma System used in water and air decontamination Corona Discharge System yields a high amount of ozone Most commonly used system corona discharge system easy to manipulate and has a precise ozone production amount Gupta Mansi 2012 Ozone has three forms of application in dentistry ozonated water ozonated olive oil ozone gas Ozonated olive oil and water show an ideal system to be used due to the ability to trap and discharges oxygen ozone Meena et al 2011
The aims of oxygenozone therapy are removal of pathogens reestablishment of proper oxygen metabolic rate stimulation of a pleasant ecologic environment improve circulation immune stimulation stimulation of an anti-oxidant systemGattani Shewale 2016
antimicrobial antibacterial antifungal and antiviral effect is claimed to be through damaging to the cytoplasmic membrane oxidation of intracellular content specific to the microbial cell effective in antibiotic resistive strain Nagayoshi M et al 2004 conducted a study to evaluate the ability of different concentrations of ozone on survival and permeability of oral microorganisms they reported that ozonated water 05-4 mgl was greatly effective in killing both gram-positive and gram-negative bacteria Some strains of gram-negative bacteria as P endodontalis and the periodontopathic bacterium P gingivalis shows more liability to ozonated water than gram-positive bacteriaNagayoshi et al 2004 Immunostimulate effect of ozone therapy was reported to be related to its effect on triggering cellular and humoral immune system Proliferation of immunocompetent cells Synthesis of immunoglobulins Enhance phagocytosis activity V Bocci nd Ozone therapy was found also to have an active role in activation of antioxidants and synthesis of interleukin leukotriene and prostaglandin V Bocci et al 2009 Gattani Shewale 2016 A systematic review by V A Bocci et al 2011 was conducted to study the interaction of ozone therapy and blood In erythrocytes it activates phosphofructokinase thus accelerate glycolysis and result in increased ATP and 2 3-diphosphoglycerate Repeated sessions allow lipid oxidation products to reach bone marrow and activate subtle development at erythropoietin level this will form new erythrocytes and improved its biochemical characteristics a phenomena named super gifted erythrocytes This super gifted erythrocytes was found to have a high content of glucose-6-phosphate dehydrogenase Ozone therapy enhanced the phagocytosis effect of neutrophil and trigger cysteine oxidation and induce the release of cytokines During the ozone therapy detection of platelet-derived growth factor subunit B TGF-b1 IL- 8 and epidermal growth factor released in heparinized plasmaBocci et al 2011 A recent randomized controlled trial was conducted to study the efficiency of ozone therapy in an early healing period of connective tissue gingival graft placed to cover root surface Taşdemir et al 2016they concluded that ozone therapy improved blood profusion during the first week of therapy which could improve wound healing and decrease post-operative pain
Patel et al 2011 evaluated the therapeutic effects of topical ozonized olive oil on the healing of post-harvested palatal donor wound sites with large epithelial and connective tissue deficiencies that heal by secondary intention The result revealed that ozonized oil significantly enhanced re-epithelialization of the palatal donor site wounds
The main challenge facing periodontal therapy is that of contamination during the early phases of healing which compromise the initial healing events In addition the tissue response to such inflammatory state that usually associated with marked reduction in anabolic mediators also compromise periodontal regeneration Since ozone therapy works on both bacterial inflammatory and host anabolic and catabolic mediators it should be studied carefully in order to investigate more and augment its role in periodontal therapyWe still have few investigations with lots of gaps still needs to be investigated Thus this study will be performed to approach the effect of ozonized olive oil mixed with the bone substitute as a biocompatible scaffold and as a possible delivery material in treating Intra-bony periodontal defects
There are three different systems for producing ozone gas Ultraviolet System yields low concentrations of ozone used in saunas esthetics and for air decontamination Cold Plasma System used in water and air decontamination Corona Discharge System yields a high amount of ozone Most commonly used system corona discharge system easy to manipulate and has a precise ozone production amount Gupta Mansi 2012 Ozone has three forms of application in dentistry ozonated water ozonated olive oil ozone gas Ozonated olive oil and water show an ideal system to be used due to the ability to trap and discharges oxygen ozone Meena et al 2011
The aims of oxygenozone therapy are removal of pathogens reestablishment of proper oxygen metabolic rate stimulation of a pleasant ecologic environment improve circulation immune stimulation stimulation of an anti-oxidant systemGattani Shewale 2016
antimicrobial antibacterial antifungal and antiviral effect is claimed to be through damaging to the cytoplasmic membrane oxidation of intracellular content specific to the microbial cell effective in antibiotic resistive strain Nagayoshi M et al 2004 conducted a study to evaluate the ability of different concentrations of ozone on survival and permeability of oral microorganisms they reported that ozonated water 05-4 mgl was greatly effective in killing both gram-positive and gram-negative bacteria Some strains of gram-negative bacteria as P endodontalis and the periodontopathic bacterium P gingivalis shows more liability to ozonated water than gram-positive bacteriaNagayoshi et al 2004 Immunostimulate effect of ozone therapy was reported to be related to its effect on triggering cellular and humoral immune system Proliferation of immunocompetent cells Synthesis of immunoglobulins Enhance phagocytosis activity V Bocci nd Ozone therapy was found also to have an active role in activation of antioxidants and synthesis of interleukin leukotriene and prostaglandin V Bocci et al 2009 Gattani Shewale 2016 A systematic review by V A Bocci et al 2011 was conducted to study the interaction of ozone therapy and blood In erythrocytes it activates phosphofructokinase thus accelerate glycolysis and result in increased ATP and 2 3-diphosphoglycerate Repeated sessions allow lipid oxidation products to reach bone marrow and activate subtle development at erythropoietin level this will form new erythrocytes and improved its biochemical characteristics a phenomena named super gifted erythrocytes This super gifted erythrocytes was found to have a high content of glucose-6-phosphate dehydrogenase Ozone therapy enhanced the phagocytosis effect of neutrophil and trigger cysteine oxidation and induce the release of cytokines During the ozone therapy detection of platelet-derived growth factor subunit B TGF-b1 IL- 8 and epidermal growth factor released in heparinized plasmaBocci et al 2011 A recent randomized controlled trial was conducted to study the efficiency of ozone therapy in an early healing period of connective tissue gingival graft placed to cover root surface Taşdemir et al 2016they concluded that ozone therapy improved blood profusion during the first week of therapy which could improve wound healing and decrease post-operative pain
Patel et al 2011 evaluated the therapeutic effects of topical ozonized olive oil on the healing of post-harvested palatal donor wound sites with large epithelial and connective tissue deficiencies that heal by secondary intention The result revealed that ozonized oil significantly enhanced re-epithelialization of the palatal donor site wounds
The main challenge facing periodontal therapy is that of contamination during the early phases of healing which compromise the initial healing events In addition the tissue response to such inflammatory state that usually associated with marked reduction in anabolic mediators also compromise periodontal regeneration Since ozone therapy works on both bacterial inflammatory and host anabolic and catabolic mediators it should be studied carefully in order to investigate more and augment its role in periodontal therapyWe still have few investigations with lots of gaps still needs to be investigated Thus this study will be performed to approach the effect of ozonized olive oil mixed with the bone substitute as a biocompatible scaffold and as a possible delivery material in treating Intra-bony periodontal defects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None