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Completed

NCT Number: NCT05544539

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

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.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Baghdad University

Baghdad, 00964, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

  • 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

Treatment and study plan

Ozone-Based Agent

Drug

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

Other names: ozone

Placebo

Drug

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

Primary outcomes

  1. measuring pain severity after extraction using numerical rating scale

    Time frame: 7 days

    severity measured using numerical rating scale from the first postoperative day to 7th day

  2. assessing the change in mouth opening using vernier caliper

    Time frame: baseline , the 2nd and 7th postoperative day

    severity, baseline , the 2nd and 7th postoperative day

  3. measuring the change in facial measurement to assess the swelling

    Time frame: baseline , the 2nd and 7th postoperative day

    severity, baseline , the 2nd and 7th postoperative day

Secondary outcomes

  1. surgical difficulty

    Time frame: through out the operation duration, an average of 1 hour

    duration and technique

  2. class

    Time frame: through out the operation duration, an average of 1 hour

    cl 1 and cl 2

  3. angulation of impaction

    Time frame: through out the operation duration, an average of 1 hour

    mesioangular , vertical, horizontal

Sponsors and collaborators

Lead sponsor

University of Baghdad

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 16, 2022
Registry last updated
Sep 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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