Effect of LLLT and Ozone to Reduce Complications After Extraction of Impacted Lower Molar

NCT05922150 | Completed

• 1 other identifier: LLLT & ozone
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Complications of Extraction of Impacted Teeth

Outcome Measures

Primary Outcomes (3)

• pain

  measurement of pain by NRS, between 0 and 10, zero meaning no pain and 10 meaning worst imaginable pain

  baseline to seventh day

• swelling

  measurement of swelling by using tape, using 3 lines

  baseline to seventh day

• trismus

  measurement of maximum mouth opening by using digital Vernia

  baseline to seventh day

Study Arms (4)

LLLT and ozone group

EXPERIMENTAL

administered of low level laser therapy and ozone gel after extraction of impacted mandibular third molar

Radiation: low level laser therapy; Drug: ozone gel

LLLT group

EXPERIMENTAL

administered of low level laser therapy after extraction of impacted mandibular third molar

Radiation: low level laser therapy

ozone group

EXPERIMENTAL

administered of low ozone gel after extraction of impacted mandibular third molar

Drug: ozone gel

control group

NO INTERVENTION

routinely extraction of impacted mandibular third molar

Interventions

low level laser therapy RADIATION

LLLT induces cellular biostimulation, speeds up tissue regeneration, enhances wound healing, and reduces pain and swelling through an anti-inflammatory effect. This is because the LLLT increases phagocytic activity, and the number and diameter of lymphatic vessels, decreases the permeability of blood vessels and restores microcapillary function

LLLT and ozone group; LLLT group

ozone gel DRUG

ozone is effective antimicrobial (viricidal, bactericidal, and fungicidal). Other well-known benefits include immunological modulatory and stimulating effects and anti-inflammatory, biosynthetic, anti-hypoxic, and bioenergeticseffects

LLLT and ozone group; ozone group

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

Osama

Baghdad, Iraq

Location

Related Publications (3)

• 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.

  PMID: 27055228 RESULT

• 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.

  PMID: 8409569 RESULT

• 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.

  PMID: 23494104 RESULT

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: postgraduate student

Study Record Dates

• First Submitted: May 27, 2023
• First Posted: June 28, 2023
• Study Start: March 9, 2022
• Primary Completion: October 1, 2022
• Study Completion: November 9, 2022
• Last Updated: June 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

IR (1)