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Clinical & Radiographic Evaluation of Zinc Oxide-Ozonated Oil as a New Primary Root Canal Filling

Primary Purpose

Pulp Disease, Dental, Obturation, Root Canal Infection

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
pulpectomy procedure and the clinical evaluation
radiographic evaluation
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulp Disease, Dental focused on measuring pulpectomy, Ozonated Olive Oil, zinc oxide eugenol, primary molars

Eligibility Criteria

4 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy & cooperative child history of spontaneous pain Percussion sensitivity presence of inter-radicular or periapical radiolucency No internal root resorption External root resorption limited to apical third and with at least two-thirds root intact. Exclusion Criteria: Uncooperativeness of child and/or parents Unrestorable tooth Presence of calcific metamorphosis inside root canals Tooth with evidence of extensive internal/external pathological root resorption.

Sites / Locations

  • Tanta UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

group 1: zinc oxide-ozonated olive oil

group 2: zinc oxide- olive oil

group 3:zinc oxide- eugenol

Arm Description

Group I: 30 primary molars were filled with fresh mix of zinc oxide powder with ozonated olive oil A single-visit pulpectomy procedure was performed . Standardized preoperative periapical radiograph was obtained to assess tooth condition & proper selection. Teeth were anesthetized & Rubber dam isolation was done, then all caries was removed & access opening was gained. Working length was determined by apex locator. All canals were prepared using Kidzo file system in a lateral brushing motion with an Endo-Mate DT endodontic motor at 350 RPM and 2.5 N/cm torque. EDTA gel 17% will be used before instrumentation & irrigation was done with normal saline. Dryness with paper points size 30 . placement of the root canal filling material (zinc oxide-ozonated olive oil) was applied . Intermediate restorative material was placed, then tooth was restored with stainless-steel crown

Group 2: 30 primary molars were filled with fresh mix of zinc oxide powder with olive oil A single-visit pulpectomy procedure was performed . Standardized preoperative periapical radiograph was obtained to assess tooth condition & proper selection. Teeth were anesthetized & Rubber dam isolation was done, then all caries was removed & access opening was gained. Working length was determined by apex locator. All canals were prepared using Kidzo file system in a lateral brushing motion with an Endo-Mate DT endodontic motor at 350 RPM and 2.5 N/cm torque. EDTA gel 17% will be used before instrumentation & irrigation was done with normal saline. Dryness with paper points size 30 . placement of the root canal filling material (zinc oxide- olive oil) was applied . Intermediate restorative material was placed, then tooth was restored with stainless-steel crown

Group 3: 30 primary molars were filled with zinc oxide- eugenol A single-visit pulpectomy procedure was performed . Standardized preoperative periapical radiograph was obtained to assess tooth condition & proper selection. Teeth were anesthetized & Rubber dam isolation was done, then all caries was removed & access opening was gained. Working length was determined by apex locator. All canals were prepared using Kidzo file system in a lateral brushing motion with an Endo-Mate DT endodontic motor at 350 RPM and 2.5 N/cm torque. EDTA gel 17% will be used before instrumentation & irrigation was done with normal saline. Dryness with paper points size 30 . placement of the root canal filling material (zinc oxide- eugenol) was applied . Intermediate restorative material was placed, then tooth was restored with stainless-steel crown

Outcomes

Primary Outcome Measures

clinical success of primary molar pulpectomy after using new root canal filling materials (Zinc Oxide-Ozonated olive Oil , Zinc Oxide- olive Oil) compared to the widely used material (zinc oxide material)
by assessing the presence or absence of spontaneous pain, presence or absence of tenderness with percussion, presence or absence of abnormal mobility and presence or absence of swelling and/or fistula during the follow-up intervals ( three, six and twelve months )
radiographic success of primary molar pulpectomy after using new root canal filling materials (Zinc Oxide-Ozonated olive Oil , Zinc Oxide- olive Oil) compared to the widely used material (zinc oxide material)
by assessing the presence or absence of extensive pathologic root resorption, reduction or no change in pre-operative pathologic inter-radicular radiolucency and presence or absence of new postoperative pathologic radiolucency. the assessment is done using periapical radiographs at three, six and twelve months after pulpectomy procedure.

Secondary Outcome Measures

Full Information

First Posted
November 21, 2022
Last Updated
April 10, 2023
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT05633537
Brief Title
Clinical & Radiographic Evaluation of Zinc Oxide-Ozonated Oil as a New Primary Root Canal Filling
Official Title
Clinical and Radiographic Evaluation of Zinc Oxide-Ozonated Oil as a New Root Canal Filling Material for Primary Molars
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 4, 2021 (Actual)
Primary Completion Date
March 1, 2023 (Actual)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Preserving primary teeth is essential for many aspects such as the child's growth and development, esthetic, functional, psychological, and dental arch integrity aspects. a randomized blinded controlled clinical trial aimed to evaluate the clinical and radiographic success of Zinc Oxide-Ozonated Olive Oil as root canal filling materials for primary molars compared to Zinc Oxide-Olive Oil & Zinc Oxide-eugenol. 90 primary molars of 30 children aged between 4-8 years with pulpally involved primary molars, are equally divided into 3 groups which treated with Zinc Oxide-Ozonated Olive Oil , zinc oxide -olive oil and zinc oxide eugenol as obturation materials following pulpectomy procedure. The subjects were followed up clinically and radiographically at 3, 6 and 12 months.
Detailed Description
Pulpectomy for primary teeth involves root canal preparation followed by obturation with a resorbable material. Zinc oxide eugenol (ZOE) is the most widely used obturating material. The main ZOE disadvantages are the difference in rate of resorption compared to the root, and limited antimicrobial activity. ZOE is formed when crude eugenol is mixed with zinc oxide. the set material easily hydrolyzes, resulting in free eugenol release which can be harmful to human soft tissues; this motivated the search for a new eugenol substitute to be combined with zinc oxide. Olive oil is a vegetable oil that comprises antioxidants, carotenoids, oleuropein, and oleocanthal, a phenolic component that significantly contributes to its antibacterial and anti-inflammatory properties. ozone in the form of ozonated olive oil, have the ability to produce nascent oxygen deep into the treated area without triggering irritation so, improved rheological characteristics, increased intracellular ATP, stimulated cellular metabolism, and expression of cytokines related to healing, particularly Transforming Growth Factor.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulp Disease, Dental, Obturation, Root Canal Infection
Keywords
pulpectomy, Ozonated Olive Oil, zinc oxide eugenol, primary molars

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group 1: zinc oxide-ozonated olive oil
Arm Type
Experimental
Arm Description
Group I: 30 primary molars were filled with fresh mix of zinc oxide powder with ozonated olive oil A single-visit pulpectomy procedure was performed . Standardized preoperative periapical radiograph was obtained to assess tooth condition & proper selection. Teeth were anesthetized & Rubber dam isolation was done, then all caries was removed & access opening was gained. Working length was determined by apex locator. All canals were prepared using Kidzo file system in a lateral brushing motion with an Endo-Mate DT endodontic motor at 350 RPM and 2.5 N/cm torque. EDTA gel 17% will be used before instrumentation & irrigation was done with normal saline. Dryness with paper points size 30 . placement of the root canal filling material (zinc oxide-ozonated olive oil) was applied . Intermediate restorative material was placed, then tooth was restored with stainless-steel crown
Arm Title
group 2: zinc oxide- olive oil
Arm Type
Experimental
Arm Description
Group 2: 30 primary molars were filled with fresh mix of zinc oxide powder with olive oil A single-visit pulpectomy procedure was performed . Standardized preoperative periapical radiograph was obtained to assess tooth condition & proper selection. Teeth were anesthetized & Rubber dam isolation was done, then all caries was removed & access opening was gained. Working length was determined by apex locator. All canals were prepared using Kidzo file system in a lateral brushing motion with an Endo-Mate DT endodontic motor at 350 RPM and 2.5 N/cm torque. EDTA gel 17% will be used before instrumentation & irrigation was done with normal saline. Dryness with paper points size 30 . placement of the root canal filling material (zinc oxide- olive oil) was applied . Intermediate restorative material was placed, then tooth was restored with stainless-steel crown
Arm Title
group 3:zinc oxide- eugenol
Arm Type
Active Comparator
Arm Description
Group 3: 30 primary molars were filled with zinc oxide- eugenol A single-visit pulpectomy procedure was performed . Standardized preoperative periapical radiograph was obtained to assess tooth condition & proper selection. Teeth were anesthetized & Rubber dam isolation was done, then all caries was removed & access opening was gained. Working length was determined by apex locator. All canals were prepared using Kidzo file system in a lateral brushing motion with an Endo-Mate DT endodontic motor at 350 RPM and 2.5 N/cm torque. EDTA gel 17% will be used before instrumentation & irrigation was done with normal saline. Dryness with paper points size 30 . placement of the root canal filling material (zinc oxide- eugenol) was applied . Intermediate restorative material was placed, then tooth was restored with stainless-steel crown
Intervention Type
Procedure
Intervention Name(s)
pulpectomy procedure and the clinical evaluation
Other Intervention Name(s)
clinical evaluation of root canal treatment of primary molars
Intervention Description
in this study, pulpectomy procedure was performed in a single visit and the root canals were filled with different obturating materials. The clinical follow up evaluation was carried out after three, six and twelve months after pulpectomy procedures. The teeth were clinically evaluated each follow up visit for the following clinical features: absence of spontaneous pain, no tenderness with percussion, no abnormal mobility and absence of swelling & sinus or fistula. If the tooth exhibited any one of above clinical features, the pulpectomy was considered to be a failure (F); otherwise, it was regarded as clinical success (S).
Intervention Type
Radiation
Intervention Name(s)
radiographic evaluation
Intervention Description
Radiographic evaluation was performed immediately after teeth restoration (base line radiograph), then after three, six and twelve months. The parallel periapical technique was performed using the rinn (XCP) periapical film holder and a long cone which was mounted to the x-ray tube. The criteria for radiographic success were no evidence of extensive pathologic root resorption, reduction or no change in pre-operative pathologic inter-radicular radiolucency and no evidence of new postoperative pathologic radiolucency.
Primary Outcome Measure Information:
Title
clinical success of primary molar pulpectomy after using new root canal filling materials (Zinc Oxide-Ozonated olive Oil , Zinc Oxide- olive Oil) compared to the widely used material (zinc oxide material)
Description
by assessing the presence or absence of spontaneous pain, presence or absence of tenderness with percussion, presence or absence of abnormal mobility and presence or absence of swelling and/or fistula during the follow-up intervals ( three, six and twelve months )
Time Frame
12 months
Title
radiographic success of primary molar pulpectomy after using new root canal filling materials (Zinc Oxide-Ozonated olive Oil , Zinc Oxide- olive Oil) compared to the widely used material (zinc oxide material)
Description
by assessing the presence or absence of extensive pathologic root resorption, reduction or no change in pre-operative pathologic inter-radicular radiolucency and presence or absence of new postoperative pathologic radiolucency. the assessment is done using periapical radiographs at three, six and twelve months after pulpectomy procedure.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy & cooperative child history of spontaneous pain Percussion sensitivity presence of inter-radicular or periapical radiolucency No internal root resorption External root resorption limited to apical third and with at least two-thirds root intact. Exclusion Criteria: Uncooperativeness of child and/or parents Unrestorable tooth Presence of calcific metamorphosis inside root canals Tooth with evidence of extensive internal/external pathological root resorption.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
shaimaa eldesouky, lecturer
Phone
+201008994242
Email
shaimaaeldesouky@dent.tanta.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
shimaa hadwa, lecturer
Phone
+201008994242
Email
shimaa.hadwa@dent.tanta.edu.eg
Facility Information:
Facility Name
Tanta University
City
Tanta
State/Province
Gharbia
ZIP/Postal Code
6624033
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaimaa eldesouky, PhD
Phone
01008994242
Email
shiamaaeldesouky@dent.tanta.edu.eg
First Name & Middle Initial & Last Name & Degree
shimaa hadwa, PhD
Phone
00201115535527
Email
shimaa.hadwa@dent.tanta.edu.eg
First Name & Middle Initial & Last Name & Degree
shaimaa eldesouky, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
21991471
Citation
Barja-Fidalgo F, Moutinho-Ribeiro M, Oliveira MA, de Oliveira BH. A systematic review of root canal filling materials for deciduous teeth: is there an alternative for zinc oxide-eugenol? ISRN Dent. 2011;2011:367318. doi: 10.5402/2011/367318. Epub 2010 Oct 17.
Results Reference
background
PubMed Identifier
24197970
Citation
Chandra SP, Chandrasekhar R, Uloopi KS, Vinay C, Kumar NM. Success of root fillings with zinc oxide-ozonated oil in primary molars: preliminary results. Eur Arch Paediatr Dent. 2014 Jun;15(3):191-5. doi: 10.1007/s40368-013-0094-8. Epub 2013 Nov 6.
Results Reference
background
PubMed Identifier
12353045
Citation
Sarrami N, Pemberton MN, Thornhill MH, Theaker ED. Adverse reactions associated with the use of eugenol in dentistry. Br Dent J. 2002 Sep 14;193(5):257-9. doi: 10.1038/sj.bdj.4801539.
Results Reference
background
PubMed Identifier
31882036
Citation
Ulusoy OI, Ekici MAG, Alacam T, Bari E, Ulusoy C. Virgin Olive Oil, Soybean Oil, and Hank's Balanced Salt Solution Used as Storage Media on Periodontal Ligament Cell Viability. Pediatr Dent. 2019 Nov 15;41(6):485-488.
Results Reference
background
PubMed Identifier
22346227
Citation
Saini R. Ozone therapy in dentistry: A strategic review. J Nat Sci Biol Med. 2011 Jul;2(2):151-3. doi: 10.4103/0976-9668.92318.
Results Reference
background

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Clinical & Radiographic Evaluation of Zinc Oxide-Ozonated Oil as a New Primary Root Canal Filling

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