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the Effect of Ozone Oil on the Postoperative Sequalae After Surgical Removal of Third Molar

Primary Purpose

Impacted Third Molar Tooth

Status
Completed
Phase
Phase 2
Locations
Iraq
Study Type
Interventional
Intervention
Ozone-Based Agent
Placebo
Sponsored by
University of Baghdad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impacted Third Molar Tooth focused on measuring third molar, ozone oil

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 1. Patients with mandibular third molar (Class I-II and position B, Pell and Gregory's classification) 2. Patients who were willing to compliance with study 3. the Surgical site free of active infection. 4. patients without any systemic disease that might affect the healing process such as uncontrolled diabetes.

Exclusion Criteria:

  • 1. Medical condition that prevent surgical intervention such as patient with bleeding disorders, recent myocardial infarction, psychiatric problem, uncontrolled systemic diseases, and patients with pacemaker, immunocompromised status and who were taking corticosteroidand anti-inflammatory drugs.

    2.. Poor oral hygiene and/or active advanced periodontal disease and, or patients with active local infection in relation to the third molar such as Pericoronitis.

    3. Smokers. 9. Any systemic condition that interfere with the use of ozone such as autoimmune disorders, myasthenia, hyperthyroidism, myocardial infarction, alcohol intoxication and ozone allergy

Sites / Locations

  • Baghdad University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

drug arm

placebo arm

Arm Description

In the study group the (0.5 ml) of Ozone oil (perio3®, Hoffmann, German) was placed inside the socket of the extracted tooth filling it completely following suturing of the flap

the ozone oil syringe was placed inside the patient mouth without applying the oil.

Outcomes

Primary Outcome Measures

measuring pain severity after extraction using numerical rating scale
severity measured using numerical rating scale from the first postoperative day to 7th day
assessing the change in mouth opening using vernier caliper
severity, baseline , the 2nd and 7th postoperative day
measuring the change in facial measurement to assess the swelling
severity, baseline , the 2nd and 7th postoperative day

Secondary Outcome Measures

surgical difficulty
duration and technique
class
cl 1 and cl 2
angulation of impaction
mesioangular , vertical, horizontal

Full Information

First Posted
September 13, 2022
Last Updated
September 15, 2022
Sponsor
University of Baghdad
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1. Study Identification

Unique Protocol Identification Number
NCT05544539
Brief Title
the Effect of Ozone Oil on the Postoperative Sequalae After Surgical Removal of Third Molar
Official Title
the Effect of Ozone Oil on the Post Operative Sequelae After Surgical Removal of Impacted Mandibular Third Molar: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
March 21, 2021 (Actual)
Primary Completion Date
July 28, 2021 (Actual)
Study Completion Date
July 28, 2021 (Actual)

3. Sponsor/Collaborators

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

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
This study aimed to evaluate the effectiveness of intra socket application of Ozone oil on postoperative pain, trismus and facial swelling following the surgical extraction of impacted mandibular third molars.
Detailed Description
Background: Surgical removal of impacted teeth is frequently encountered in dental clinic. Pain, trismus, and swelling are common postoperative sequelae for third molar surgery. Different methods have been used to prevent or decrease these postoperative sequelae, one of them is the application of Ozone oil that shows many advantages in controlling the inflammation, thus reducing pain, trismus and swelling. There is an evidence to suggest that it may have significant effects in the synthesis, release, and metabolism of a series of biochemical substances. Aim of the study: This study aimed to evaluate the effects of local application of Ozone oil on postoperative pain, trismus and facial swelling following the surgical removal of mandibular third molars. Materials and Methods: This triple blind randomized prospective clinical trial was performed during period from January 2021 until the end of July 2021, on (40) patients, age range was between (18-35) years, with impacted mandibular third molar in similar positions (Class I-II and position B, Pell and Gregory's classification). They were randomly assigned into two groups, 20 patients for Ozone oil group treated with topical application of Ozone oil in their socket, and 20 patients into the control group in which the Ozone oil syringe was inserted inside the patient mouth without applying the treatment. Assessment of trismus was done by measuring the maximum mouth opening and the swelling was assessed by measuring distance between five predetermined points (tragus, angle of mouth, pogonion, lateral angle of eye and angle of mandible). These measurements were done before surgery as a baseline record as well as at the second and seventh postoperative days. Pain was evaluated using numeric rating scale from the day of surgery until the seventh day.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impacted Third Molar Tooth
Keywords
third molar, ozone oil

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
drug arm
Arm Type
Experimental
Arm Description
In the study group the (0.5 ml) of Ozone oil (perio3®, Hoffmann, German) was placed inside the socket of the extracted tooth filling it completely following suturing of the flap
Arm Title
placebo arm
Arm Type
Placebo Comparator
Arm Description
the ozone oil syringe was placed inside the patient mouth without applying the oil.
Intervention Type
Drug
Intervention Name(s)
Ozone-Based Agent
Other Intervention Name(s)
ozone
Intervention Description
In the study group Ozone oil was placed inside the socket of the extracted tooth following suturing of the flap
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
In the control group Ozone oil syringe was placed inside the socket of the extracted tooth without applying the oil
Primary Outcome Measure Information:
Title
measuring pain severity after extraction using numerical rating scale
Description
severity measured using numerical rating scale from the first postoperative day to 7th day
Time Frame
7 days
Title
assessing the change in mouth opening using vernier caliper
Description
severity, baseline , the 2nd and 7th postoperative day
Time Frame
baseline , the 2nd and 7th postoperative day
Title
measuring the change in facial measurement to assess the swelling
Description
severity, baseline , the 2nd and 7th postoperative day
Time Frame
baseline , the 2nd and 7th postoperative day
Secondary Outcome Measure Information:
Title
surgical difficulty
Description
duration and technique
Time Frame
through out the operation duration, an average of 1 hour
Title
class
Description
cl 1 and cl 2
Time Frame
through out the operation duration, an average of 1 hour
Title
angulation of impaction
Description
mesioangular , vertical, horizontal
Time Frame
through out the operation duration, an average of 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1. Patients with mandibular third molar (Class I-II and position B, Pell and Gregory's classification) 2. Patients who were willing to compliance with study 3. the Surgical site free of active infection. 4. patients without any systemic disease that might affect the healing process such as uncontrolled diabetes. Exclusion Criteria: 1. Medical condition that prevent surgical intervention such as patient with bleeding disorders, recent myocardial infarction, psychiatric problem, uncontrolled systemic diseases, and patients with pacemaker, immunocompromised status and who were taking corticosteroidand anti-inflammatory drugs. 2.. Poor oral hygiene and/or active advanced periodontal disease and, or patients with active local infection in relation to the third molar such as Pericoronitis. 3. Smokers. 9. Any systemic condition that interfere with the use of ozone such as autoimmune disorders, myasthenia, hyperthyroidism, myocardial infarction, alcohol intoxication and ozone allergy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maiyada Talib
Organizational Affiliation
Baghdad university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baghdad University
City
Baghdad
ZIP/Postal Code
00964
Country
Iraq

12. IPD Sharing Statement

Plan to Share IPD
No

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the Effect of Ozone Oil on the Postoperative Sequalae After Surgical Removal of Third Molar

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