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

the Effect of Ozone Oil on the Post Operative Sequelae After Surgical Removal of Impacted Mandibular Third Molar: Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Impacted Third Molar Tooth
• Intervention / Treatment: Drug: Ozone-Based Agent; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Iraq
  • Baghdad, Iraq, 00964
    • Baghdad University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: drug arm; 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	Drug: Ozone-Based Agent; In the study group Ozone oil was placed inside the socket of the extracted tooth following suturing of the flap; Other Names: ozone
Placebo Comparator: placebo arm; the ozone oil syringe was placed inside the patient mouth without applying the oil.	Drug: Placebo; In the control group Ozone oil syringe was placed inside the socket of the extracted tooth without applying the oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measuring pain severity after extraction using numerical rating scale	severity measured using numerical rating scale from the first postoperative day to 7th day	7 days
assessing the change in mouth opening using vernier caliper	severity, baseline , the 2nd and 7th postoperative day	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	baseline , the 2nd and 7th postoperative day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
surgical difficulty	duration and technique	through out the operation duration, an average of 1 hour
class	cl 1 and cl 2	through out the operation duration, an average of 1 hour
angulation of impaction	mesioangular , vertical, horizontal	through out the operation duration, an average of 1 hour

Collaborators and Investigators

• Sponsor: University of Baghdad
• Investigators: Principal Investigator: Maiyada Talib, Baghdad University

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2021
• Primary Completion (Actual): July 28, 2021
• Study Completion (Actual): July 28, 2021

Study Registration Dates

• First Submitted: September 13, 2022
• First Submitted That Met QC Criteria: September 15, 2022
• First Posted (Actual): September 16, 2022

Study Record Updates

• Last Update Posted (Actual): September 16, 2022
• Last Update Submitted That Met QC Criteria: September 15, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: third molar; ozone oil
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth, Impacted
• Other Study ID Numbers: mandibular third molar

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No