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Clinical and Biochemical Assessment of Ozonated Olive Oil Mixed Bone Substitute in Treating Intra Bony Periodontal Defect

Primary Purpose

Periodontitis

Status
Recruiting
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
ozonized olive oil
xenograft bone substitute
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring intrabony defect

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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. -

Sites / Locations

  • Ain Shams UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Group I

Group II

Group III

Arm Description

ten patients will be subjected to place bone substitute mixed with Olive oil in intra bony defect. ( Control group)

ten patients will be subjected to place bone substitute mixed with ozonated olive oil in intra bony defect without further application of ozonated oil.

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

Outcomes

Primary Outcome Measures

intrabony defect fill
regeneration of intrabony defect with enhance in clinical parameter

Secondary Outcome Measures

BMP2
increase of GCF of bone morphogenic protein 2

Full Information

First Posted
December 10, 2022
Last Updated
December 10, 2022
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05655923
Brief Title
Clinical and Biochemical Assessment of Ozonated Olive Oil Mixed Bone Substitute in Treating Intra Bony Periodontal Defect
Official Title
Clinical and Biochemical Assessment of Ozonated Olive Oil Mixed Bone Substitute in Treating Intra Bony Periodontal Defect- Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
February 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
intrabony defect

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
ozonized olive oil
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Placebo Comparator
Arm Description
ten patients will be subjected to place bone substitute mixed with Olive oil in intra bony defect. ( Control group)
Arm Title
Group II
Arm Type
Active Comparator
Arm Description
ten patients will be subjected to place bone substitute mixed with ozonated olive oil in intra bony defect without further application of ozonated oil.
Arm Title
Group III
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
ozonized olive oil
Intervention Description
ozonized oil will be mixed with xenograft in group II and Group III
Intervention Type
Biological
Intervention Name(s)
xenograft bone substitute
Other Intervention Name(s)
deproteinized bovine bone
Intervention Description
Xenograft bone substitutes in all Groups
Primary Outcome Measure Information:
Title
intrabony defect fill
Description
regeneration of intrabony defect with enhance in clinical parameter
Time Frame
6 months
Secondary Outcome Measure Information:
Title
BMP2
Description
increase of GCF of bone morphogenic protein 2
Time Frame
3 weeks

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
nourhan adel aldorri, dr
Phone
00201210566004
Email
nourhanaldorri89@gmail.com
Facility Information:
Facility Name
Ain Shams University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18166260
Citation
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.
Results Reference
background
PubMed Identifier
21575276
Citation
Bocci 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.
Results Reference
background
PubMed Identifier
15209994
Citation
Nagayoshi 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.
Results Reference
background
PubMed Identifier
9579616
Citation
Laurell 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.
Results Reference
background
PubMed Identifier
25426896
Citation
Patel 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.
Results Reference
background
PubMed Identifier
26777769
Citation
Tasdemir 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.
Results Reference
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Clinical and Biochemical Assessment of Ozonated Olive Oil Mixed Bone Substitute in Treating Intra Bony Periodontal Defect

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