Clinical trial NCT05922150: Effect of LLLT and Ozone to Reduce Complications After Extraction of Impacted Lower Molar
Official title: Efficiency of Low Level Laser Therapy and Ozone on Sequelae After Extraction of Impacted Mandibular Third Molar
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complications of Extraction of Impacted Teeth
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Many factors cause third molars to stay impacted in the jaws, hence the extraction of impacted wisdom teeth occurs often in dental clinics. Pain, trismus, and edema are typical postoperative complications following third molar surgery. Various strategies have been developed to prevent or reduce these postoperative complications, Among these is the use of Low-Level Laser Therapy (LLLT), which demonstrates numerous benefits in lowering pain, trismus, and edema by managing inflammation. The precise biological mechanism of action remains unknown. There seems to be evidence that it may have neuro-pharmacological impacts on the production, metabolism, and release of a number of biological compounds, the other option is use of ozone which has antimicrobial effectiveness (viricidal, bactericidal, and fungicidal). Additional well-known advantages include immunological modulatory and stimulating actions, including anti-inflammatory, biosynthetic, anti-hypoxic, and bioenergetic characteristics. Ozone can interact with blood components in the right amounts to positively impact oxygen metabolism and cell energy while also triggering antioxidant defense mechanisms


Eligibility criteria: Inclusion Criteria:

* Patients who had mandibular third molar, totally or partially impacted in the bone (Class II-III and position B, Pell and Gregory's classification), in need of surgical extraction, which were evaluated clinically and by radiological examination.
* Patients who were in age range between 18-40 years old.
* Patients who were willing to compliance with study and were available for follow up.
* Patients should be with good oral hygiene and without any acute illness

Exclusion Criteria:

* Patients with medical condition that prevent any surgical intervention such as patient with recent myocardial infarction, bleeding disorders, psychiatric problem and patients with pacemaker, uncontrolled systemic disease, immunocompromised patient and patients taking corticosteroid and anti-inflammatory drugs.
* Patients with history of head and neck radiotherapy.
* Pregnant or lactation women
* Active advanced uncontrolled periodontal disease and bad oral hygiene, or patients with local acute infection in relation to third molar especially pericoronitis.
* Patients who suffer from photodermatoses and photosensitized patients (photoallergies).
* Hyperthyroidism

Primary outcomes:
measure: pain
timeFrame: baseline to seventh day
measure: swelling
timeFrame: baseline to seventh day
measure: trismus
timeFrame: baseline to seventh day
Secondary outcomes:
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Osama
Study officials:
References:
citation: Eshghpour M, Ahrari F, Takallu M. Is Low-Level Laser Therapy Effective in the Management of Pain and Swelling After Mandibular Third Molar Surgery? J Oral Maxillofac Surg. 2016 Jul;74(7):1322.e1-8. doi: 10.1016/j.joms.2016.02.030. Epub 2016 Mar 12.
citation: Roynesdal AK, Bjornland T, Barkvoll P, Haanaes HR. The effect of soft-laser application on postoperative pain and swelling. A double-blind, crossover study. Int J Oral Maxillofac Surg. 1993 Aug;22(4):242-5. doi: 10.1016/s0901-5027(05)80646-0.
citation: Kazancioglu HO, Ezirganli S, Demirtas N. Comparison of the influence of ozone and laser therapies on pain, swelling, and trismus following impacted third-molar surgery. Lasers Med Sci. 2014 Jul;29(4):1313-9. doi: 10.1007/s10103-013-1300-y. Epub 2013 Mar 14.