Impacted Third Molar ToothPhase 2NCT05544539
the Effect of Ozone Oil on the Postoperative Sequalae After Surgical Removal of Third Molar
A Phase 2 study testing Ozone-Based Agent in people with Impacted Third Molar Tooth, run by University of Baghdad at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Impacted Third Molar Tooth
- What is being tested?
- Ozone-Based Agent
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIraq
- Study dates
- 21 Mar 2021to 28 Jul 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Ozone-Based Agent, Placebo
- Keywords
- third molar, ozone oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ozone-Based AgentDrug
Also called ozone
In the study group Ozone oil was placed inside the socket of the extracted tooth following suturing of the flap
PlaceboDrug
In the control group Ozone oil syringe was placed inside the socket of the extracted tooth without applying the oil
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Ozone-Based Agent |
| placebo arm | Placebo comparator | the ozone oil syringe was placed inside the patient mouth without applying the oil. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
measuring pain severity after extraction using numerical rating scale
severity measured using numerical rating scale from the first postoperative day to 7th day
Measured: 7 days
assessing the change in mouth opening using vernier caliper
severity, baseline , the 2nd and 7th postoperative day
Measured: 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
Measured: baseline , the 2nd and 7th postoperative day
Secondary outcomes (3)
surgical difficulty
duration and technique
Measured: through out the operation duration, an average of 1 hour
class
cl 1 and cl 2
Measured: through out the operation duration, an average of 1 hour
angulation of impaction
mesioangular , vertical, horizontal
Measured: through out the operation duration, an average of 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start21 Mar 2021
- Primary completion28 Jul 2021
- Study completion28 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impacted Third Molar ToothStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maiyada A. Talib, University of Baghdad
- Investigators
- Maiyada Talib, Principal investigator, Baghdad university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05544539
- Sponsor's protocol ID
- mandibular third molar
- Status last verified
- Sep 2022
- First submitted
- 13 Sep 2022
- Last updated
- 16 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of Ozone Oil on the Post Operative Sequelae After Surgical Removal of Impacted Mandibular Third Molar: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05544539
- Acronym / sponsor ID
- mandibular third molar
- Conditions
- Impacted Third Molar Tooth
- Keywords
- third molar, ozone oil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 21 Mar 2021 (actual)
- Primary completion
- 28 Jul 2021 (actual)
- Study completion
- 28 Jul 2021 (actual)
- First posted
- 16 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| drug arm | Experimental | Drug: Ozone-Based AgentIn 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 |
| placebo arm | Placebo comparator | Drug: Placebothe ozone oil syringe was placed inside the patient mouth without applying the oil. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ozone-Based AgentAlso: ozoneIn the study group Ozone oil was placed inside the socket of the extracted tooth following suturing of the flap | Drug | drug arm |
| PlaceboIn the control group Ozone oil syringe was placed inside the socket of the extracted tooth without applying the oil | Drug | placebo arm |
Primary outcome
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
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
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
3 secondary outcomes
surgical difficulty
Time frame: through out the operation duration, an average of 1 hour
class
Time frame: through out the operation duration, an average of 1 hour
angulation of impaction
Time frame: through out the operation duration, an average of 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maiyada Talib principal investigator
Baghdad university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ozone-Based Agent in people with Impacted Third Molar Tooth, run by University of Baghdad at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measuring pain severity after extraction using numerical rating scale (time frame: 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2022.