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

Primary Purpose

Complications of Extraction of Impacted Teeth

Status
Completed
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
low level laser therapy
ozone gel
Sponsored by
University of Baghdad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Complications of Extraction of Impacted Teeth

Eligibility Criteria

18 Years - 38 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Osama

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

LLLT and ozone group

LLLT group

ozone group

control group

Arm Description

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

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

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

routinely extraction of impacted mandibular third molar

Outcomes

Primary Outcome Measures

pain
measurement of pain by NRS, between 0 and 10, zero meaning no pain and 10 meaning worst imaginable pain
swelling
measurement of swelling by using tape, using 3 lines
trismus
measurement of maximum mouth opening by using digital Vernia

Secondary Outcome Measures

Full Information

First Posted
May 27, 2023
Last Updated
June 18, 2023
Sponsor
University of Baghdad
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1. Study Identification

Unique Protocol Identification Number
NCT05922150
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 9, 2022 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
November 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Baghdad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complications of Extraction of Impacted Teeth

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LLLT and ozone group
Arm Type
Experimental
Arm Description
administered of low level laser therapy and ozone gel after extraction of impacted mandibular third molar
Arm Title
LLLT group
Arm Type
Experimental
Arm Description
administered of low level laser therapy after extraction of impacted mandibular third molar
Arm Title
ozone group
Arm Type
Experimental
Arm Description
administered of low ozone gel after extraction of impacted mandibular third molar
Arm Title
control group
Arm Type
No Intervention
Arm Description
routinely extraction of impacted mandibular third molar
Intervention Type
Radiation
Intervention Name(s)
low level laser therapy
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
ozone gel
Intervention Description
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 Outcome Measure Information:
Title
pain
Description
measurement of pain by NRS, between 0 and 10, zero meaning no pain and 10 meaning worst imaginable pain
Time Frame
baseline to seventh day
Title
swelling
Description
measurement of swelling by using tape, using 3 lines
Time Frame
baseline to seventh day
Title
trismus
Description
measurement of maximum mouth opening by using digital Vernia
Time Frame
baseline to seventh day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Osama
City
Baghdad
Country
Iraq

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
27055228
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.
Results Reference
result
PubMed Identifier
8409569
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.
Results Reference
result
PubMed Identifier
23494104
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.
Results Reference
result

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

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