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OpenTrials
Completed

NCT Number: NCT05922150

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

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

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Key information

Age range

18 year–38 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Osama

Baghdad, Iraq

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. pain

    Time frame: 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

    Time frame: baseline to seventh day

    measurement of swelling by using tape, using 3 lines

  3. trismus

    Time frame: baseline to seventh day

    measurement of maximum mouth opening by using digital Vernia

Sponsors and collaborators

Lead sponsor

University of Baghdad

Other

Registry information

Official study title

Efficiency of Low Level Laser Therapy and Ozone on Sequelae After Extraction of Impacted Mandibular Third Molar

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 28, 2023
Registry last updated
Jun 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.