PeriodontitisPhase 1/2NCT05655923
Clinical and Biochemical Assessment of Ozonated Olive Oil Mixed Bone Substitute in Treating Intra Bony Periodontal Defect
A Phase 1/2 study testing ozonized olive oil and xenograft bone substitute in people with Periodontitis, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- ozonized olive oil and xenograft bone substitute
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2022to Feb 2023
- Phase
- Phase 1/2
- 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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- chronic periodontitis requiring surgical intervention to treat an intra-bony defect adjacent to a natural tooth One or more periodontal defects with PD >6 mm, radiographic vertical bony defect >3 mm in depth, and radiographic base of defect >2 mm coronal to the root apex.
- Systemically healthy as evidence by a medical questionnaire guided by modified cornel medical index Availability for multiple follow-up appointments.
Who cannot join
- Smokers women who were pregnant or intended to become pregnant during the study period Patient unwilling to perform hygienic instructions Untreated infection at the study site other than periodontitis Tooth mobility Miller Class II or III Subgingival restoration, untreated caries at or below the cement enamel junction (CEJ), root fracture, or apical pathology.
- Vulnerable individuals Presence of systemic diseases.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Biochemical Assessment of Ozonated Olive Oil Mixed Bone Substitute in Treating Intra Bony Periodontal Defect- Randomized Clinical Trial
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.
Read the 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 field(Azarpazhooh \& 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 bleeding.(Gupta \& 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 oxygen/ozone 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 system.(Gattani \& 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 (0.5-4 mg/l) 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 bacteria.(Nagayoshi 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 immunoglobulin's, Enhance phagocytosis activity (V. Bocci, n.d.). 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 plasma(Bocci 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. 2016)they 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 therapy.We 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.
- Conditions
- Periodontitis
- Being tested
- ozonized olive oil, xenograft bone substitute
- Keywords
- intrabony defect
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ozonized olive oilBiological
ozonized oil will be mixed with xenograft in group II and Group III
xenograft bone substituteBiological
Also called deproteinized bovine bone
Xenograft bone substitutes in all Groups
| Study group | Role | What they receive |
|---|---|---|
| Group I | Placebo comparator | ten patients will be subjected to place bone substitute mixed with Olive oil in intra bony defect. ( Control group) Receives: Biological: xenograft bone substitute |
| Group II | Active comparator | ten patients will be subjected to place bone substitute mixed with ozonated olive oil in intra bony defect without further application of ozonated oil. Receives: Biological: ozonized olive oil; Biological: xenograft bone substitute |
| Group III | Active comparator | ten patients will be subjected to place bone substitute mixed with ozonated olive oil in intra bony defect with further weekly application of ozonated olive oil until third week Receives: Biological: ozonized olive oil; Biological: xenograft bone substitute |
What is being measured
The primary outcome is the main question the study is designed to answer.
intrabony defect fill
regeneration of intrabony defect with enhance in clinical parameter
Measured: 6 months
Secondary outcomes (1)
BMP2
increase of GCF of bone morphogenic protein 2
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start1 Jul 2022
- Primary completionJan 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- ozonized olive oil
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourhan adel mohammed mahmoud aldorri, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05655923
- Sponsor's protocol ID
- ozonized oil in periodontitis
- Status last verified
- Dec 2022
- First submitted
- 10 Dec 2022
- Last updated
- 19 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Azarpazhooh A, Limeback H. The application of ozone in dentistry: a systematic review of literature. J Dent. 2008 Feb;36(2):104-16. doi: 10.1016/j.jdent.2007.11.008. Epub 2007 Dec 31.
PubMed 18166260Bocci VA, Zanardi I, Travagli V. Ozone acting on human blood yields a hormetic dose-response relationship. J Transl Med. 2011 May 17;9:66. doi: 10.1186/1479-5876-9-66.
PubMed 21575276Nagayoshi M, Fukuizumi T, Kitamura C, Yano J, Terashita M, Nishihara T. Efficacy of ozone on survival and permeability of oral microorganisms. Oral Microbiol Immunol. 2004 Aug;19(4):240-6. doi: 10.1111/j.1399-302X.2004.00146.x.
PubMed 15209994Laurell L, Gottlow J, Zybutz M, Persson R. Treatment of intrabony defects by different surgical procedures. A literature review. J Periodontol. 1998 Mar;69(3):303-13. doi: 10.1902/jop.1998.69.3.303.
PubMed 9579616Patel PV, Kumar V, Kumar S, Gd V, Patel A. Therapeutic effect of topical ozonated oil on the epithelial healing of palatal wound sites: a planimetrical and cytological study. J Investig Clin Dent. 2011 Nov;2(4):248-58. doi: 10.1111/j.2041-1626.2011.00072.x. Epub 2011 Jul 7.
PubMed 25426896Tasdemir Z, Alkan BA, Albayrak H. Effects of Ozone Therapy on the Early Healing Period of Deepithelialized Gingival Grafts: A Randomized Placebo-Controlled Clinical Trial. J Periodontol. 2016 Jun;87(6):663-71. doi: 10.1902/jop.2016.150217. Epub 2016 Jan 16.
PubMed 26777769
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Biochemical Assessment of Ozonated Olive Oil Mixed Bone Substitute in Treating Intra Bony Periodontal Defect- Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05655923
- Acronym / sponsor ID
- ozonized oil in periodontitis
- Conditions
- Periodontitis
- Keywords
- intrabony defect
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 19 Dec 2022 (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 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 field(Azarpazhooh \& 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 bleeding.(Gupta \& 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 oxygen/ozone 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 system.(Gattani \& 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 (0.5-4 mg/l) 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 bacteria.(Nagayoshi 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 immunoglobulin's, Enhance phagocytosis activity (V. Bocci, n.d.). 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 plasma(Bocci 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. 2016)they 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 therapy.We 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- ozonized olive oil
| Arm | Type | Receives |
|---|---|---|
| Group I | Placebo comparator | Biological: xenograft bone substituteten patients will be subjected to place bone substitute mixed with Olive oil in intra bony defect. ( Control group) |
| Group II | Active comparator | Biological: ozonized olive oil, Biological: xenograft bone substituteten patients will be subjected to place bone substitute mixed with ozonated olive oil in intra bony defect without further application of ozonated oil. |
| Group III | Active comparator | Biological: ozonized olive oil, Biological: xenograft bone substituteten patients will be subjected to place bone substitute mixed with ozonated olive oil in intra bony defect with further weekly application of ozonated olive oil until third week |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- chronic periodontitis requiring surgical intervention to treat an intra-bony defect adjacent to a natural tooth One or more periodontal defects with PD >6 mm, radiographic vertical bony defect >3 mm in depth, and radiographic base of defect >2 mm coronal to the root apex.
- Systemically healthy as evidence by a medical questionnaire guided by modified cornel medical index Availability for multiple follow-up appointments.
Key exclusion criteria (3 listed)
- Smokers women who were pregnant or intended to become pregnant during the study period Patient unwilling to perform hygienic instructions Untreated infection at the study site other than periodontitis Tooth mobility Miller Class II or III Subgingival restoration, untreated caries at or below the cement enamel junction (CEJ), root fracture, or apical pathology.
- Vulnerable individuals Presence of systemic diseases.
- -
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 |
|---|---|---|
| ozonized olive oilozonized oil will be mixed with xenograft in group II and Group III | Biological | Group II, Group III |
| xenograft bone substituteAlso: deproteinized bovine boneXenograft bone substitutes in all Groups | Biological | Group I, Group II, Group III |
Primary outcome
intrabony defect fill
Time frame: 6 months
regeneration of intrabony defect with enhance in clinical parameter
1 secondary outcome
BMP2
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2022.
- Background: PubMed 18166260Azarpazhooh A, Limeback H. The application of ozone in dentistry: a systematic review of literature. J Dent. 2008 Feb;36(2):104-16. doi: 10.1016/j.jdent.2007.11.008. Epub 2007 Dec 31.
- Background: PubMed 21575276Bocci VA, Zanardi I, Travagli V. Ozone acting on human blood yields a hormetic dose-response relationship. J Transl Med. 2011 May 17;9:66. doi: 10.1186/1479-5876-9-66.
- Background: PubMed 15209994Nagayoshi M, Fukuizumi T, Kitamura C, Yano J, Terashita M, Nishihara T. Efficacy of ozone on survival and permeability of oral microorganisms. Oral Microbiol Immunol. 2004 Aug;19(4):240-6. doi: 10.1111/j.1399-302X.2004.00146.x.
- Background: PubMed 9579616Laurell L, Gottlow J, Zybutz M, Persson R. Treatment of intrabony defects by different surgical procedures. A literature review. J Periodontol. 1998 Mar;69(3):303-13. doi: 10.1902/jop.1998.69.3.303.
- Background: PubMed 25426896Patel PV, Kumar V, Kumar S, Gd V, Patel A. Therapeutic effect of topical ozonated oil on the epithelial healing of palatal wound sites: a planimetrical and cytological study. J Investig Clin Dent. 2011 Nov;2(4):248-58. doi: 10.1111/j.2041-1626.2011.00072.x. Epub 2011 Jul 7.
- Background: PubMed 26777769Tasdemir Z, Alkan BA, Albayrak H. Effects of Ozone Therapy on the Early Healing Period of Deepithelialized Gingival Grafts: A Randomized Placebo-Controlled Clinical Trial. J Periodontol. 2016 Jun;87(6):663-71. doi: 10.1902/jop.2016.150217. Epub 2016 Jan 16.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ozonized olive oil and xenograft bone substitute in people with Periodontitis, run by Ain Shams University at 1 site in Egypt.
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 2 inclusion and 3 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 19 Dec 2022. 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 Egypt. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact nourhan adel aldorri, dr (00201210566004, nourhanaldorri89@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intrabony defect fill (time frame: 6 months). 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 NCT05655923, which also lists 6 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 19 Dec 2022.