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

Sponsor
University of Baghdad (Other)
Overall Status
Completed
CT.gov ID
NCT05922150
Collaborator
(none)
60
1
4
8
7.5

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Radiation: low level laser therapy
  • Drug: ozone gel
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Efficiency of Low Level Laser Therapy and Ozone on Sequelae After Extraction of Impacted Mandibular Third Molar
Actual Study Start Date :
Mar 9, 2022
Actual Primary Completion Date :
Oct 1, 2022
Actual Study Completion Date :
Nov 9, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: LLLT and ozone group

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

Radiation: low level laser therapy
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

Drug: ozone gel
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

Experimental: LLLT group

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

Radiation: low level laser therapy
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

Experimental: ozone group

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

Drug: ozone gel
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

No Intervention: control group

routinely extraction of impacted mandibular third molar

Outcome Measures

Primary Outcome Measures

  1. pain [baseline to seventh day]

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

  2. swelling [baseline to seventh day]

    measurement of swelling by using tape, using 3 lines

  3. trismus [baseline to seventh day]

    measurement of maximum mouth opening by using digital Vernia

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 38 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Osama Baghdad Iraq

Sponsors and Collaborators

  • University of Baghdad

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Osama Abdulkathim Ali, postgraduate student, University of Baghdad
ClinicalTrials.gov Identifier:
NCT05922150
Other Study ID Numbers:
  • LLLT & ozone
First Posted:
Jun 28, 2023
Last Update Posted:
Jun 28, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 28, 2023