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

NCT ID: NCT05544539

Last Updated: 2022-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-21
• Study Completion Date: 2021-07-28

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.

Conditions

Impacted Third Molar Tooth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Ozone-Based Agent

Intervention Type: DRUG

In the study group Ozone oil was placed inside the socket of the extracted tooth following suturing of the flap

placebo arm

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

In the control group Ozone oil syringe was placed inside the socket of the extracted tooth without applying the oil

Interventions

Ozone-Based Agent

In the study group Ozone oil was placed inside the socket of the extracted tooth following suturing of the flap

Intervention Type: DRUG

Placebo

In the control group Ozone oil syringe was placed inside the socket of the extracted tooth without applying the oil

Intervention Type: DRUG

Other Intervention Names

ozone

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Baghdad

OTHER

Sponsor Role: lead

Responsible Party

Maiyada A. Talib

dentist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maiyada Talib

Role: PRINCIPAL_INVESTIGATOR

Baghdad university

Locations

Baghdad University

Baghdad, , Iraq

Countries

Iraq

Other Identifiers

mandibular third molar

Identifier Type: -

Identifier Source: org_study_id