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

NCT05544539 | Completed Phase 2

• 1 other identifier: mandibular third molar
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Impacted Third Molar Tooth

Keywords

third molar; ozone oil

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• surgical difficulty

  through out the operation duration, an average of 1 hour

• class

  through out the operation duration, an average of 1 hour

• angulation of impaction

  through out the operation duration, an average of 1 hour

Study Arms (2)

drug arm

EXPERIMENTAL

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

placebo arm

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Ozone-Based Agent DRUG

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

Also known as: ozone

drug arm

Placebo DRUG

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

placebo arm

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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.
• 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

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

Baghdad University

Baghdad, 00964, Iraq

Location

MeSH Terms

Interventions

Ozone

Intervention Hierarchy (Ancestors)

Oxygen; Gases; Inorganic Chemicals

Study Officials

• Maiyada Talib

  Baghdad university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dentist

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 16, 2022
• Study Start: March 21, 2021
• Primary Completion: July 28, 2021
• Study Completion: July 28, 2021
• Last Updated: September 16, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)