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

NCT05655923 | Unknown Phase 1 DMC

• 1 other identifier: ozonized oil in periodontitis
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis

Keywords

intrabony defect

Outcome Measures

Primary Outcomes (1)

• intrabony defect fill

  regeneration of intrabony defect with enhance in clinical parameter

  6 months

Secondary Outcomes (1)

• BMP2

  3 weeks

Study Arms (3)

Group I

PLACEBO COMPARATOR

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

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.

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

Biological: ozonized olive oil; Biological: xenograft bone substitute

Interventions

ozonized olive oil BIOLOGICAL

ozonized oil will be mixed with xenograft in group II and Group III

Group II; Group III

xenograft bone substitute BIOLOGICAL

Xenograft bone substitutes in all Groups

Also known as: deproteinized bovine bone

Group I; Group II; Group III

Eligibility Criteria

• Age: 25 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

RECRUITING

Related Publications (6)

• 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.

  PMID: 18166260 BACKGROUND

• 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.

  PMID: 21575276 BACKGROUND

• 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.

  PMID: 15209994 BACKGROUND

• 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.

  PMID: 9579616 BACKGROUND

• 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.

  PMID: 25426896 BACKGROUND

• 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.

  PMID: 26777769 BACKGROUND

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

nourhan adel aldorri, dr

CONTACT

00201210566004; nourhanaldorri89@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Model Details: ozonized olive oil

Study Record Dates

• First Submitted: December 10, 2022
• First Posted: December 19, 2022
• Study Start: July 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: February 1, 2023
• Last Updated: December 19, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)